Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-28 @ 12:57 PM
Study NCT ID:
NCT03171532
Status:
UNKNOWN
Last Update Posted:
2017-05-31
First Post:
2017-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-28', 'studyFirstSubmitDate': '2017-02-09', 'studyFirstSubmitQcDate': '2017-05-28', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport/Rec Score (Function in Sport and Recreation) change from baseline', 'timeFrame': 'Baseline, 1 year and 2 years post op', 'description': 'Patient reported outcome'}], 'secondaryOutcomes': [{'measure': 'Tegner-Lysholm Score change from baseline', 'timeFrame': 'Baseline, 1 year and 2 years post op', 'description': 'Patient reported outcome'}, {'measure': 'International Knee Documentation Committee (IKDC) Grade change from baseline', 'timeFrame': 'Baseline, 1 year and 2 years post op', 'description': 'Patient reported outcome'}, {'measure': 'KOOS Pain change from baseline', 'timeFrame': 'Baseline, 1 year and 2 years post op', 'description': 'Patient reported outcome'}, {'measure': 'KOOS Symptoms change from baseline', 'timeFrame': 'Baseline, 1 year and 2 years post op', 'description': 'Patient reported outcome'}, {'measure': 'KOOS Function in daily living (KOOS ADL) change from baseline', 'timeFrame': 'Baseline, 1 year and 2 years post op', 'description': 'Patient reported outcome'}, {'measure': 'KOOS Knee-related Quality of Life (KOOS QOL) change from baseline', 'timeFrame': 'Baseline, 1 year and 2 years post op', 'description': 'Patient reported outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ACL'], 'conditions': ['Physical Activity']}, 'descriptionModule': {'briefSummary': 'This study aims to study differences in clinical and functional outcomes at 2 years based on hamstring graft size after single bundle anatomic ACL reconstruction using either 4-strand or 5-strand hamstring grafts. We also propose to study the characteristics of hamstring graft in our subset of patients in Asian population context.', 'detailedDescription': 'This will be a prospective, randomized interventional study conducted at the National University Hospital under University Orthopaedics and Hand surgery Cluster during the period of December 2015 to December 2018. Study participants: The study will include 80 patients with complete Anterior Cruciate Ligament (ACL) tear undergoing primary arthroscopic reconstruction with ipsilateral hamstring autograft after written informed consent to participate in the study.\n\nThe subjects will be divided into two groups A) 4-strand hamstring or B) 5-strand hamstring group by block randomization using an online randomization generator (http://www.graphpad.com/quickcalcs). All the subjects will undergo the procedure by otherwise identical technique performed by single surgeon. At 1 and 2 years functional and subjective outcomes will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age above 18 years\n2. Clinical and MRI confirmed complete ACL tear\n3. Ipsilateral hamstring autograft\n4. Concomitant meniscus injury requiring either meniscus repair or partial menisectomy\n5. Concomitant chondral injury Grade 0,1,2 (International Cartilage Repair Society)\n6. Regular scheduled follow up with adherence to prescribed rehab protocol\n\nExclusion Criteria:\n\n1. Non consent\n2. Paediatric patient; age less than 18 years\n3. Partial or incomplete ACL tear\n4. Revision ACL surgery\n5. Hamstring allograft\n6. Multi-ligament injury of the knee (ACL and/or Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament, Postero Lateral Corner)\n7. Past history of knee surgery\n8. Contra-lateral ACL injury or other ligament injury\n9. Chondral injury Grade 3,4 (International Cartilage Repair Society)\n10. Intra-articular fracture (past or current)\n11. Radiologically evident osteoarthritis changes'}, 'identificationModule': {'nctId': 'NCT03171532', 'briefTitle': 'Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Comparison of Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament (ACL) Reconstruction: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2015/00652'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '4 strand hamstring ACL reconstruction', 'description': 'The hamstring tendons will be harvested by standard technique and the lengths of the Semitendinosus and Gracilis tendons will be measured after clearing all adherent muscle tissue. The ends will be prepared and folded in middle to prepare4-strand graft.', 'interventionNames': ['Procedure: Strands of Hamstring Autograft in ACL reconstruction']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5 strand hamstring ACL reconstruction', 'description': 'The hamstring tendons will be harvested by standard technique and the lengths of the Semitendinosus (ST) and Gracilis (GR) tendons will be measured after clearing all adherent muscle tissue. For 5-strand graft, minimum length of ST and GR in consideration would be 24 cm and 16 cm respectively. For 5-strand group the ST tendon will be be folded twice and sutured on itself to make a three strand graft and then GR tendon will be folded once along with it to make a final 5-strand graft.', 'interventionNames': ['Procedure: Strands of Hamstring Autograft in ACL reconstruction']}], 'interventions': [{'name': 'Strands of Hamstring Autograft in ACL reconstruction', 'type': 'PROCEDURE', 'description': 'The femoral and tibial ends will be tubularised and the final graft diameter will be recorded after passing through sizing cylinders graduated in 0.5mm increments. The femoral and tibial tunnels will be drilled as per standard technique for single bundle ACL reconstruction via trans-portal or trans-tibial route and both ends fixed by interference screw with additional post on the tibial end.', 'armGroupLabels': ['4 strand hamstring ACL reconstruction', '5 strand hamstring ACL reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Lingaraj Krishna, FRCS (Orth)', 'role': 'CONTACT', 'email': 'lingaraj_krishna@nuhs.edu.sg', 'phone': '+6567795555'}, {'name': 'Amritpal Singh, MBBS', 'role': 'CONTACT', 'email': 'amritpal_singh@nuhs.edu.sg', 'phone': '+6567795555'}], 'facility': 'National University Health System', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Lingaraj Krishna, FRCS (Orth)', 'role': 'CONTACT', 'email': 'lingaraj_krishna@nuhs.edu.sg', 'phone': '+6567795555'}, {'name': 'Amritpal Singh, MBBS', 'role': 'CONTACT', 'email': 'amritpal_singh@nuhs.edu.sg', 'phone': '+6567795555'}], 'overallOfficials': [{'name': 'Lingaraj Krishna, FRCS (Orth)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}