Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-04 @ 6:39 PM
Study NCT ID:
NCT00529958
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2007-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050376', 'term': 'Bone-Patellar Tendon-Bone Grafting'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D059549', 'term': 'Anterior Cruciate Ligament Reconstruction'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aclstudy@ucalgary.ca', 'phone': '403-220-8944', 'title': 'ACL RCT Research Coordinator', 'organization': 'University of Calgary Sport Medicine Centre'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Two years post-operatively.', 'description': "Patient-reported adverse events by phone, email or at regularly scheduled follow-up visits. Unexpected/unusual problems with the patient's knee were assessed in clinic, diagnosed and managed accordingly. Patients presenting with emergent concerns were initially seen in the hospital emergency department. All patients experiencing an adverse event/complication were followed (by phone, email, regularly scheduled or additional visits) until the issue was completely resolved or appropriately managed.", 'eventGroups': [{'id': 'EG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 20, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 22, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 38, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Failed Meniscal Repair', 'notes': 'Requiring repeat surgery for medial meniscal tears. There were no lateral meniscal tears.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stiffness', 'notes': 'Intra-articular scarring requiring repeat surgery, caused by generalized arthrofibrosis (1), Cyclops lesions (4), or graft hypertrophy causing impingement (4).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hamstring Injury', 'notes': 'Hamstring injuries on the ipsilateral side, include hamstring strain (18 patients) and a hamstring tear (1 patient with a patellar tendon graft; tear due to a major traumatic event while wakeboarding).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tibial Periostitis', 'notes': 'Diagnosed as pain, swelling, redness and tenderness isolated to the medial tibial surface, distinct from pain in the knee. All presented within 2 weeks post-operatively; all successfully treated with nonsteroidal anti-inflammatory drugs (NSAIDS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Wound Infection', 'notes': 'Treated successfully with IV and oral antibiotics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Superficial Wound Infection', 'notes': 'Successfully treated with oral antibiotics.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sensory Nerve Problems', 'notes': 'Related to graft harvest/portal incisions (5 patients) or as a result of medial meniscal repair (3 patients); treated with topical NSAIDs cream and corticosteroid injections. All problems were resolved except one resulting in long-term dysesthesia.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stitch Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Meniscal Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Patellar Tendinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chondral Lesion', 'notes': 'Requiring surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistent Effusion/Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hardware Issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Septic Arthritis', 'notes': 'Detected 1 month post-operatively; treated with arthroscopic washout, intravenous antibiotics and successful preservation of the graft. Coagulase-negative Staphylococcus was the identified organism. Complete resolution.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Massive Pulmonary Embolism', 'notes': 'Identified at 2 weeks post-operatively; treated successfully with anticoagulation and an IVC filter with no long-term sequelae. Complete resolution.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Vein Thrombosis', 'notes': 'Identified 18 days post-operatively; treated successfully with anticoagulant therapy with no clinical sequelae.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft'}, {'id': 'OG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'OG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.0', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '29.8', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '28.7', 'spread': '13.7', 'groupId': 'OG002'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47.7', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '52.6', 'spread': '19.2', 'groupId': 'OG001'}, {'value': '50.5', 'spread': '16.9', 'groupId': 'OG002'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61.7', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '65.2', 'spread': '18.4', 'groupId': 'OG001'}, {'value': '65.5', 'spread': '17.9', 'groupId': 'OG002'}]}]}, {'title': '1-Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '74.5', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '75.4', 'spread': '18.5', 'groupId': 'OG001'}, {'value': '73.6', 'spread': '19.2', 'groupId': 'OG002'}]}]}, {'title': '2-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '84.6', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '82.5', 'spread': '17.7', 'groupId': 'OG001'}, {'value': '82.4', 'spread': '17.5', 'groupId': 'OG002'}]}]}, {'title': '5-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '82.5', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '83.9', 'spread': '18.2', 'groupId': 'OG001'}, {'value': '81.1', 'spread': '19.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'A Bonferroni adjustment for multiple comparisons was used in the sample size calculation, resulting in 90 patients per group. With a 20% lost-to-follow-up rate, the final sample size was 108 patients per group for a total of 324 patients.', 'groupDescription': 'All patients were analyzed on an "intention-to-treat" basis using a 5% significance level for all analyses. The ACL-QOL scores for each study group were analyzed using adjusted Bonferroni comparisons and repeated-measures analyses, using a mixed-model analysis of variance for treatment group over time of assessment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The sample size calculation was based on 88 ACL-deficient patients with surgical intervention and an ACL-QOL score of 74.5 (SD=20.1) at a mean 39-month follow-up, a minimal clinically important difference of 10 points, power=0.80 and p=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 and 6 months, 1, 2, and 5 years post-operatively', 'description': 'The 32-item patient-reported Anterior Cruciate Ligament Quality-of-Life (ACL-QOL) questionnaire assesses symptoms/physical complaints, work-related, sports/recreational, lifestyle and social/emotional concerns. A higher score on the 0 to 100mm visual analog scale represents better quality of life.', 'unitOfMeasure': 'Score (0 to 100)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft'}, {'id': 'OG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'OG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}], 'classes': [{'title': 'Minimum 2-Year Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'title': 'No re-injury or failure', 'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}, {'title': 'Complete Traumatic Re-rupture', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}, {'title': 'Partial Traumatic Tear', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Atraumatic Graft Failure', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': '5-Year Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'title': 'No re-injury or failure', 'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}, {'title': 'Complete Traumatic Re-rupture', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}, {'title': 'Partial Traumatic Tear', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'Atraumatic Graft Failure', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Minimum 2-year Follow-up, 5-Year Follow-up, 10-Year Follow-up', 'description': '* COMPLETE TRAUMATIC RE-RUPTURE - defined as a consequence of an acute traumatic event resulting in a change in static stability since the most recent follow-up visit; determined clinically by a definite loss of end point on Lachman testing, increased anterior translation (\\>3mm) and a greater than or equal grade 2 pivot shift. Confirmed by MRI or diagnostic arthroscopy.\n* PARTIAL TRAUMATIC TEARS - defined as a consequence of an acute traumatic event resulting in a suspected meniscal injury or graft tear on history, without the clinical characteristics of a "complete traumatic rerupture". Confirmed by MR or diagnostic arthroscopy.\n* TRAUMATIC RE-INJURY - combined total of "complete traumatic re-ruptures" and "partial traumatic tears".\n* ATRAUMATIC GRAFT FAILURES - defined in the absence of an acute traumatic event, with greater than or equal grade 2 pivot shift and/or greater than or equal to 6mm side-to-side difference on the KT arthrometer.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 110 participants randomized to each study group. At 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft'}, {'id': 'OG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'OG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal (A)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Nearly Normal (B)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Abnormal (C)', 'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}, {'title': 'Severely Abnormal (D)', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '1-Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal (A)', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'title': 'Nearly Normal (B)', 'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}, {'title': 'Abnormal (C)', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}, {'title': 'Severely Abnormal (D)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '2-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal (A)', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}, {'title': 'Nearly Normal (B)', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}, {'title': 'Abnormal (C)', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}, {'title': 'Severely Abnormal (D)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '5-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Normal (A)', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}, {'title': 'Nearly Normal (B)', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}, {'title': 'Abnormal (C)', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}, {'title': 'Severely Abnormal (D)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 1, 2, 5 years post-operatively', 'description': 'IKDC Objective group grades: Normal (A), Nearly Normal (B), Abnormal (C), Severely Abnormal (D) The IKDC Objective Overall Group Grade is determined by the lowest grade assigned to defined objective knee examination measurements, including effusion, passive motion deficit and manual/instrumented ligament examinations (i.e. Lachman, anterior-posterior (AP) translation).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 110 participants randomized to each study group. At 1-, 2-, and 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.'}, {'type': 'SECONDARY', 'title': 'Mean International Knee Documentation Committee (IKDC) Subjective Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft'}, {'id': 'OG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'OG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.1', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '51.0', 'spread': '16.2', 'groupId': 'OG001'}, {'value': '51.5', 'spread': '14.6', 'groupId': 'OG002'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '60.2', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '65.7', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '63.1', 'spread': '12.1', 'groupId': 'OG002'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '71.1', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '76.1', 'spread': '13.1', 'groupId': 'OG001'}, {'value': '75.8', 'spread': '11.1', 'groupId': 'OG002'}]}]}, {'title': '1-Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '79.7', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '81.7', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '80.0', 'spread': '11.9', 'groupId': 'OG002'}]}]}, {'title': '2-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '84.6', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '85.3', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '84.2', 'spread': '11.8', 'groupId': 'OG002'}]}]}, {'title': '5-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '83.9', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '85.2', 'spread': '13.0', 'groupId': 'OG001'}, {'value': '84.3', 'spread': '13.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively', 'description': 'Patient-reported health-related outcome measure with a score between 0 and 100. A higher score represents a better outcome.', 'unitOfMeasure': 'score on a scale (out of 100)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 110 participants randomized to each study group. At 1-, 2- and 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Each Pivot Shift Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft'}, {'id': 'OG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'OG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Equal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Glide (+)', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'title': 'Clunk (++)', 'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}, {'title': 'Gross (+++)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Equal', 'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}, {'title': 'Glide (+)', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}, {'title': 'Clunk (++)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Gross (+++)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Equal', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}, {'title': 'Glide (+)', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}, {'title': 'Clunk (++)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Gross (+++)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '1-Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Equal', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}, {'title': 'Glide (+)', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}, {'title': 'Clunk (++)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}, {'title': 'Gross (+++)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '2-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Equal', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}, {'title': 'Glide (+)', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}, {'title': 'Clunk (++)', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}, {'title': 'Gross (+++)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '5-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Equal', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}, {'title': 'Glide (+)', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}, {'title': 'Clunk (++)', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}, {'title': 'Gross (+++)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively', 'description': 'The Pivot Shift test is a dynamic, passive test to assess the rotational instability of the Anterior Cruciate Ligament in the knee.\n\nPivot shift grades include: equal/0 (negative); glide/1; clunk/2; gross/3. A positive grade indicates injury to the Anterior Cruciate Ligament.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Moderate or Severe Kneeling Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft'}, {'id': 'OG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'OG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': '5 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 2 and 5 years post-operatively', 'description': 'Patients kneeled down on the same hard surface (i.e. clinic floor) and self-reported the pain on a scale of: none, mild, moderate or severe. The number of patients reporting moderate or severe kneeling pain were combined in the reported proportions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At 2 and 5-year follow-up, outcome data was not collected on all participants due to loss-to-follow-up, withdrawal or missed study visits.'}, {'type': 'SECONDARY', 'title': 'Knee Laxity as Measured by the KT Arthrometer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft'}, {'id': 'OG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'OG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': '1-Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': '2-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '2.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 and 2 years post-operatively', 'description': 'Mean side-to-side differences, as measured using the KT-1000 Arthrometer instrument at 30lbs/134N forces to objectively measure knee laxity.', 'unitOfMeasure': 'Millimetres (side-to-side difference)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.'}, {'type': 'SECONDARY', 'title': 'Mean Tegner Activity Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft'}, {'id': 'OG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'OG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '7.9', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '2.0', 'groupId': 'OG002'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '1.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months, 1 and 2 years post-operatively', 'description': 'Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10))', 'unitOfMeasure': 'Activity Level', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.'}, {'type': 'SECONDARY', 'title': 'Return to Pre-injury Tegner Activity Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft'}, {'id': 'OG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'OG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}], 'classes': [{'title': '1 Year', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': '2 Years', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': '5 Years', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1, 2 and 5 years post-operatively', 'description': 'Proportion of patients returning to pre-injury levels, as measured by the Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10)).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 110 participants randomized to each study group. At 1-, 2- and 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.'}, {'type': 'SECONDARY', 'title': 'Cincinnati Occupational Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft'}, {'id': 'OG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'OG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.6', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '35.4', 'spread': '21.3', 'groupId': 'OG001'}, {'value': '36.3', 'spread': '17.7', 'groupId': 'OG002'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.7', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '36.1', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '36.4', 'spread': '19.3', 'groupId': 'OG002'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.7', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '37.4', 'spread': '21.6', 'groupId': 'OG001'}, {'value': '37.0', 'spread': '20.2', 'groupId': 'OG002'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.7', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '38.0', 'spread': '22.0', 'groupId': 'OG001'}, {'value': '38.0', 'spread': '21.5', 'groupId': 'OG002'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.8', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '34.4', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '38.0', 'spread': '22.5', 'groupId': 'OG002'}]}]}, {'title': '5 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.9', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '23.8', 'groupId': 'OG001'}, {'value': '37.8', 'spread': '24.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively', 'description': 'The Cincinnati Occupational Rating Scale assesses the level of work-related activities, including sitting, standing, walking, squatting, climbing, lifting and carrying weighted objects. The score ranges from 0 to 100, with a lower score representing more sedentary work-related activities.', 'unitOfMeasure': 'score on a scale (out of 100)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.'}, {'type': 'SECONDARY', 'title': 'Skin-to-Skin Operative Times', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft'}, {'id': 'OG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'OG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}], 'classes': [{'categories': [{'measurements': [{'value': '75.3', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '67.8', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '88.0', 'spread': '14.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During surgery', 'description': 'Skin-to-skin operative times (in minutes) for each ACL reconstruction procedure', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Radiographic (X-ray) Changes', 'timeFrame': 'Baseline, 2 and 5 years post-operatively', 'description': 'The analysis for the radiographic assessment data is currently ongoing, to provide a comparison of baseline, 2- and 5-year post-operative x-rays.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-03'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft'}, {'id': 'OG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'OG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}], 'classes': [{'title': 'Deep wound infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Superficial wound infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Chondral lesion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Failed meniscal repair', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Stiffness', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hamstring injury', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Tibial periostitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Stitch abscess', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Cellulitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Meniscal cyst', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Patellar tendinopathy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Persistent effusion / inflammation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Sensory nerve problems', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Wound dehiscence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hardware issues', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Massive pulmonary embolism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Deep vein thrombosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Septic arthritis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years post-operatively', 'description': 'All complications/adverse events that occurred within the first two-years post-operatively.\n\nSee Adverse Events section for results of this outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft'}, {'id': 'FG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'FG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}], 'periods': [{'title': '2-Year Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'comment': '110 randomized to HT, but there was (n=1) cross-over from the DB group', 'groupId': 'FG001', 'numSubjects': '110'}, {'comment': '110 randomized to DB, but there was (n=1) cross-over to the HT group', 'groupId': 'FG002', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'comment': '108 HT patients analyzed excludes n=1 cross-over patient (analyzed on intention-to-treat basis).', 'groupId': 'FG001', 'numSubjects': '108'}, {'comment': '108 DB patients analyzed include 1 cross-over with HT graft (analyzed on intention-to-treat basis).', 'groupId': 'FG002', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': '5-Year Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'comment': '108 HT patients available for 5-year follow-up excludes n=1 cross-over patient from the DB group', 'groupId': 'FG001', 'numSubjects': '108'}, {'comment': '108 DB patients available for 5-year follow-up includes n=1 cross-over with a single-bundle HT graft', 'groupId': 'FG002', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '105'}, {'groupId': 'FG002', 'numSubjects': '107'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '330', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft\n\nPatellar Tendon: Patellar Tendon autograft'}, {'id': 'BG001', 'title': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft\n\nHamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'BG002', 'title': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft\n\nDouble-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '28.5', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '28.3', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '28.5', 'spread': '9.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '183', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronicity: Acute, Chronic', 'classes': [{'categories': [{'title': 'Acute', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}, {'title': 'Chronic', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '281', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Injured side: Left, Right', 'classes': [{'categories': [{'title': 'Left', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}, {'title': 'Right', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'N=110 patients were randomized to each study group. One cross-over from the DB group received an HT graft, but was analyzed as part of the DB study group.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-15', 'studyFirstSubmitDate': '2007-09-12', 'resultsFirstSubmitDate': '2017-11-07', 'studyFirstSubmitQcDate': '2007-09-12', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-12', 'studyFirstPostDateStruct': {'date': '2007-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome)', 'timeFrame': '2 years post-operatively', 'description': 'All complications/adverse events that occurred within the first two-years post-operatively.\n\nSee Adverse Events section for results of this outcome.'}], 'primaryOutcomes': [{'measure': 'Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome', 'timeFrame': 'Baseline, 3 and 6 months, 1, 2, and 5 years post-operatively', 'description': 'The 32-item patient-reported Anterior Cruciate Ligament Quality-of-Life (ACL-QOL) questionnaire assesses symptoms/physical complaints, work-related, sports/recreational, lifestyle and social/emotional concerns. A higher score on the 0 to 100mm visual analog scale represents better quality of life.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures', 'timeFrame': 'Minimum 2-year Follow-up, 5-Year Follow-up, 10-Year Follow-up', 'description': '* COMPLETE TRAUMATIC RE-RUPTURE - defined as a consequence of an acute traumatic event resulting in a change in static stability since the most recent follow-up visit; determined clinically by a definite loss of end point on Lachman testing, increased anterior translation (\\>3mm) and a greater than or equal grade 2 pivot shift. Confirmed by MRI or diagnostic arthroscopy.\n* PARTIAL TRAUMATIC TEARS - defined as a consequence of an acute traumatic event resulting in a suspected meniscal injury or graft tear on history, without the clinical characteristics of a "complete traumatic rerupture". Confirmed by MR or diagnostic arthroscopy.\n* TRAUMATIC RE-INJURY - combined total of "complete traumatic re-ruptures" and "partial traumatic tears".\n* ATRAUMATIC GRAFT FAILURES - defined in the absence of an acute traumatic event, with greater than or equal grade 2 pivot shift and/or greater than or equal to 6mm side-to-side difference on the KT arthrometer.'}, {'measure': 'Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade', 'timeFrame': 'Baseline, 1, 2, 5 years post-operatively', 'description': 'IKDC Objective group grades: Normal (A), Nearly Normal (B), Abnormal (C), Severely Abnormal (D) The IKDC Objective Overall Group Grade is determined by the lowest grade assigned to defined objective knee examination measurements, including effusion, passive motion deficit and manual/instrumented ligament examinations (i.e. Lachman, anterior-posterior (AP) translation).'}, {'measure': 'Mean International Knee Documentation Committee (IKDC) Subjective Score', 'timeFrame': 'Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively', 'description': 'Patient-reported health-related outcome measure with a score between 0 and 100. A higher score represents a better outcome.'}, {'measure': 'Number of Participants With Each Pivot Shift Grade', 'timeFrame': 'Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively', 'description': 'The Pivot Shift test is a dynamic, passive test to assess the rotational instability of the Anterior Cruciate Ligament in the knee.\n\nPivot shift grades include: equal/0 (negative); glide/1; clunk/2; gross/3. A positive grade indicates injury to the Anterior Cruciate Ligament.'}, {'measure': 'Proportion of Patients With Moderate or Severe Kneeling Pain', 'timeFrame': 'Baseline, 2 and 5 years post-operatively', 'description': 'Patients kneeled down on the same hard surface (i.e. clinic floor) and self-reported the pain on a scale of: none, mild, moderate or severe. The number of patients reporting moderate or severe kneeling pain were combined in the reported proportions.'}, {'measure': 'Knee Laxity as Measured by the KT Arthrometer', 'timeFrame': 'Baseline, 1 and 2 years post-operatively', 'description': 'Mean side-to-side differences, as measured using the KT-1000 Arthrometer instrument at 30lbs/134N forces to objectively measure knee laxity.'}, {'measure': 'Mean Tegner Activity Level', 'timeFrame': 'Baseline, 6 months, 1 and 2 years post-operatively', 'description': 'Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10))'}, {'measure': 'Return to Pre-injury Tegner Activity Level', 'timeFrame': '1, 2 and 5 years post-operatively', 'description': 'Proportion of patients returning to pre-injury levels, as measured by the Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10)).'}, {'measure': 'Cincinnati Occupational Rating Scale', 'timeFrame': 'Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively', 'description': 'The Cincinnati Occupational Rating Scale assesses the level of work-related activities, including sitting, standing, walking, squatting, climbing, lifting and carrying weighted objects. The score ranges from 0 to 100, with a lower score representing more sedentary work-related activities.'}, {'measure': 'Skin-to-Skin Operative Times', 'timeFrame': 'During surgery', 'description': 'Skin-to-skin operative times (in minutes) for each ACL reconstruction procedure'}, {'measure': 'Radiographic (X-ray) Changes', 'timeFrame': 'Baseline, 2 and 5 years post-operatively', 'description': 'The analysis for the radiographic assessment data is currently ongoing, to provide a comparison of baseline, 2- and 5-year post-operative x-rays.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anterior Cruciate Ligament (ACL) Reconstruction', 'Patellar Tendon', 'Hamstring Tendon', 'Double-Bundle', 'Autograft'], 'conditions': ['Anterior Cruciate Ligament Rupture', 'Deficiency of Anterior Cruciate Ligament', 'Chronic Instability of Knee', 'Anterior Cruciate Ligament Injury']}, 'referencesModule': {'references': [{'pmid': '9617395', 'type': 'BACKGROUND', 'citation': 'Mohtadi N. Development and validation of the quality of life outcome measure (questionnaire) for chronic anterior cruciate ligament deficiency. Am J Sports Med. 1998 May-Jun;26(3):350-9. doi: 10.1177/03635465980260030201.'}, {'pmid': '21901700', 'type': 'BACKGROUND', 'citation': 'Mohtadi NG, Chan DS, Dainty KN, Whelan DB. Patellar tendon versus hamstring tendon autograft for anterior cruciate ligament rupture in adults. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD005960. doi: 10.1002/14651858.CD005960.pub2.'}, {'pmid': '25881568', 'type': 'RESULT', 'citation': 'Mohtadi N, Barber R, Chan D, Paolucci EO. Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction. Clin J Sport Med. 2016 May;26(3):182-9. doi: 10.1097/JSM.0000000000000202.'}, {'pmid': '25514139', 'type': 'RESULT', 'citation': 'Mohtadi N, Chan D, Barber R, Oddone Paolucci E. A Randomized Clinical Trial Comparing Patellar Tendon, Hamstring Tendon, and Double-Bundle ACL Reconstructions: Patient-Reported and Clinical Outcomes at a Minimal 2-Year Follow-up. Clin J Sport Med. 2015 Jul;25(4):321-31. doi: 10.1097/JSM.0000000000000165.'}, {'pmid': '26164058', 'type': 'RESULT', 'citation': 'Mohtadi N, Chan D, Barber R, Paolucci EO. Reruptures, Reinjuries, and Revisions at a Minimum 2-Year Follow-up: A Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction. Clin J Sport Med. 2016 Mar;26(2):96-107. doi: 10.1097/JSM.0000000000000209.'}, {'pmid': '31169571', 'type': 'RESULT', 'citation': 'Mohtadi NG, Chan DS. A Randomized Clinical Trial Comparing Patellar Tendon, Hamstring Tendon, and Double-Bundle ACL Reconstructions: Patient-Reported and Clinical Outcomes at 5-Year Follow-up. J Bone Joint Surg Am. 2019 Jun 5;101(11):949-960. doi: 10.2106/JBJS.18.01322.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized clinical trial is to determine the difference in quality of life outcome at two years, in patients undergoing an Anterior Cruciate Ligament (ACL) reconstruction procedure with either a patellar tendon, quadruple hamstring tendon or a double-bundle hamstring tendon autograft.', 'detailedDescription': 'Following an ACL injury, the knee is predisposed to chronic instability, further damage to the meniscal and chondral structures in the knee, osteoarthritis and an impaired quality of life. The successful treatment of an ACL deficient knee aims to preserve the intact meniscus and chondral structures, and to provide a functionally stable knee so that patients can return to pre-injury activities and restore their quality of life. The current standard of care for ACL deficient knees is with a surgical ACL reconstruction procedure. A Cochrane Review was done and demonstrated that the existing literature is controversial. To date, no existing trial has used validated patient-based outcome assessment, accounted for the critical differences between acute and chronic ACL deficiency or used modern techniques to ensure randomization concealment and a sufficient sample size to avoid type II error. The existing information does not define graft failure or re-ruptures, involve long-term follow-up to address osteoarthritis development, nor compare outcomes between single- and double-bundle reconstructive techniques. The current standard includes either a patellar tendon or quadruple semitendinosus/gracilis tendon autograft reconstruction. The newest option is a double-bundle semitendinosus/gracilis graft. This option attempts to restore the complex ACL anatomy by using two separate tendon components to reconstruct the ACL. This study will measure disease-specific quality of life at short- and long-term post-operative intervals (1, 2, 5 and 10 years). Additional secondary outcomes, including the incidence of traumatic re-ruptures and graft failures, will also be compared between treatment groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nA confirmed diagnosis of anterior cruciate ligament deficiency based on all of the following:\n\n* History of a traumatic injury episode\n* Physical examination findings of increased anterior translation of the tibia on the femur (Lachman test and/or anterior drawer test)\n* A positive pivot shift test\n* X-rays showing skeletal maturity (ie: tibial tubercle fused) and no fractures. (NB: Magnetic resonance imaging is not required)\n* Age 14-50 years old\n\nExclusion Criteria:\n\n* Patients with combined ligament deficiencies (Posterior Cruciate, Medial and/or Lateral Collateral deficiency.) (NB: Grade 1 side to side differences (ie. \\< 5mm) on valgus, varus or posterior stress testing will not be considered exclusions)\n* Intra-operative identification of International Cartilage Repair Society (ICRS) Grade 4 chondral lesion of \\> 1 cm ² \\[61\\]\n* Previous ligament surgery on the affected or contralateral knees\n* Cases involving litigation or Worker's Compensation\n* Confirmed connective tissue disorder (ie: Ehlers-Danlos, Marfans)\n* X-ray showing that tibial physis is not fused"}, 'identificationModule': {'nctId': 'NCT00529958', 'briefTitle': 'Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'A Randomized Clinical Trial Comparing Three Methods for Anterior Cruciate Ligament Reconstruction: Patellar Tendon, Quadruple Semitendinosus/Gracilis and Double-Bundle Semitendinosus/Gracilis Grafts.', 'orgStudyIdInfo': {'id': 'REB15-1061 (formerly 20966)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patellar Tendon (PT)', 'description': 'ACL reconstruction using a patellar tendon autograft', 'interventionNames': ['Procedure: Patellar Tendon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hamstring (HT)', 'description': 'ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft', 'interventionNames': ['Procedure: Hamstring Tendon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Double-Bundle (DB)', 'description': 'ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft', 'interventionNames': ['Procedure: Double-Bundle']}], 'interventions': [{'name': 'Patellar Tendon', 'type': 'PROCEDURE', 'otherNames': ['Bone-patellar tendon-bone graft', 'BTPB graft'], 'description': 'Patellar Tendon autograft', 'armGroupLabels': ['Patellar Tendon (PT)']}, {'name': 'Hamstring Tendon', 'type': 'PROCEDURE', 'otherNames': ['Single-bundle hamstring graft', 'ST/G graft'], 'description': 'Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft', 'armGroupLabels': ['Hamstring (HT)']}, {'name': 'Double-Bundle', 'type': 'PROCEDURE', 'otherNames': ['Double-bundle ST/G graft'], 'description': 'Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft', 'armGroupLabels': ['Double-Bundle (DB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 1N4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary Sport Medicine Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Nicholas G Mohtadi, MD MSc FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary Sport Medicine Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': "Workers' Compensation Board, Alberta", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor and Orthopaedic Surgeon', 'investigatorFullName': 'Dr. Nicholas Mohtadi', 'investigatorAffiliation': 'University of Calgary'}}}}