Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
Study NCT ID:
NCT04528992
Status:
WITHDRAWN
Last Update Posted:
2024-11-25
First Post:
2020-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Blood Flow Restriction (BFR) Therapy on ACL Graft Maturation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090003', 'term': 'Blood Flow Restriction Therapy'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'BFR Physical Therapy Protocol was not finalized and department had multiple similar studies.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2020-08-24', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in MRI imaging of Graft', 'timeFrame': '2 weeks, 3 months, 6 months', 'description': 'Graft ligamentization or maturation on MRI using T2 mapping'}, {'measure': 'Difference in Quadriceps Volume & Cross-sectional Area', 'timeFrame': '3 months, 6 months', 'description': 'Quadriceps muscle atrophy measured on MRI with quadriceps cross-sectional area'}, {'measure': 'Difference in Thigh Circumference Measurement', 'timeFrame': '3 months, 6 months', 'description': 'Muscle measurement determined with measuring tape for thigh circumference'}], 'secondaryOutcomes': [{'measure': 'Isokinetic Dynamometer', 'timeFrame': '2 weeks, 3 months, 6 months', 'description': 'Measurement of knee extension and flexion torque at 180° and 300°/sec using the isokinetic dynamometer'}, {'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '2 weeks, 3 months, 6 months', 'description': 'Patient reported assessment of current level of pain from no pain to worst imaginable'}, {'measure': 'Single Assessment Numerical Evaluation (SANE)', 'timeFrame': '2 weeks, 3 months, 6 months', 'description': 'Patient reported outcome measure of function. 0-100% scale with 100% being normal'}, {'measure': 'International Knee Documentation Committee (IKDC)', 'timeFrame': '2 weeks, 3 months, 6 months', 'description': 'Patient reported outcome measure of symptoms, sports activity \\& knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Injuries', 'Anterior Cruciate Ligament Injuries']}, 'descriptionModule': {'briefSummary': 'This is a study comparing the effects of blood flow restriction (BFR) therapy on the maturation of the Anterior Cruciate Ligament (ACL) graft after reconstruction surgery compared to physical therapy without the use of BFR.', 'detailedDescription': "The study will be a randomized controlled trial to compare outcomes between physical therapy with BFR and physical therapy without BFR on the ACL graft maturation following reconstruction surgery. BFR therapy will begin as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR, will consist of the physical therapy following the surgeon's postoperative protocol.\n\nTo be considered for participation in this study, patients must be 18 years and older undergoing primary ACL reconstruction. In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ages 18 or older, all gender\n* Patients receiving any type of ACL graft, either autograft or allograft, and any type of tissue\n\nExclusion Criteria:\n\n* Patients who do not meet the the comprehensive BFR screening criteria based on predetermined contraindications and precautions\n* Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery\n* Revision procedures\n* Patients unable to lay still in an MRI scanner\n* Patients receiving treatment outside Stanford\n* Patients undergoing concomitant meniscus treatment that restricts patients' weight bearing or prolongs their immobilization compared to their surgeons standard postoperative ACL reconstruction protocol\n* Patients who are unable to lay still in an MRI scanner\n* Patients with a torn ACL or previous ACL reconstruction in the contralateral knee"}, 'identificationModule': {'nctId': 'NCT04528992', 'briefTitle': 'Effects of Blood Flow Restriction (BFR) Therapy on ACL Graft Maturation', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Effects of Blood Flow Restriction (BFR) Therapy on Early Anterior Cruciate Ligament (ACL) Graft Maturation', 'orgStudyIdInfo': {'id': 'IRB-56716'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical Therapy with BFR', 'description': "Participants will begin BFR therapy as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR will consist of the physical therapy following the surgeon's postoperative protocol.", 'interventionNames': ['Other: Blood Flow Restriction Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physical Therapy without BFR', 'description': "Participants will undergo standard physical therapy following the surgeon's postoperative protocol.", 'interventionNames': ['Other: Standard Postoperative Physical Therapy']}], 'interventions': [{'name': 'Blood Flow Restriction Therapy', 'type': 'OTHER', 'description': "BFR is a rehabilitation method that involves wearing a tight band around the exercising extremity to briefly limit blood flow while doing light weight exercises. The response is similar to heavy weight training or lifting but without the stress on the extremity that is still healing from surgery. Will be given after 2 weeks standard postoperative physical therapy per surgeon's ACL reconstruction protocol following surgery.", 'armGroupLabels': ['Physical Therapy with BFR']}, {'name': 'Standard Postoperative Physical Therapy', 'type': 'OTHER', 'description': "This is the surgeon's standard postoperative physical therapy protocol after ACL reconstruction.", 'armGroupLabels': ['Physical Therapy without BFR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}], 'overallOfficials': [{'name': 'Seth Sherman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Seth Sherman', 'investigatorAffiliation': 'Stanford University'}}}}