Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-30 @ 7:25 AM
Study NCT ID:
NCT04374968
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2020-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Blood Flow Restriction Therapy Following ACL Tear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}, {'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant and investigator will be aware of treatment arm allocation. Outcomes will be assessed in a masked fashion'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel randomized controlled trial with a treatment and control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-05-01', 'lastUpdatePostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quadriceps Strength', 'timeFrame': 'Three months', 'description': 'Quadriceps strength via handheld dynamometer'}], 'secondaryOutcomes': [{'measure': 'Quadriceps Strength', 'timeFrame': 'six months', 'description': 'Quadriceps strength via handheld dynamometer'}, {'measure': 'Knee range of motion', 'timeFrame': 'three months', 'description': 'Knee range of motion via goniometer'}, {'measure': 'Knee range of motion', 'timeFrame': 'six months', 'description': 'Knee range of motion via goniometer'}, {'measure': 'Patient reported outcome measurement information system', 'timeFrame': 'Three months', 'description': 'Patient reported outcomes measurement information system score on patient physical function, scale 0-100 with higher scores better'}, {'measure': 'Patient reported outcomes measurement information system', 'timeFrame': 'Six months', 'description': 'Patient reported outcomes measurement information system score on patient physical function, scale 0-100 with higher scores better'}, {'measure': 'international knee documentation committee questionnaire', 'timeFrame': 'three months', 'description': 'international knee documentation committee questionnaire, scale 0-100 with higher scores better'}, {'measure': 'international knee documentation committee questionnaire', 'timeFrame': 'six months', 'description': 'international knee documentation committee questionnaire, scale 0-100 with higher scores better'}, {'measure': 'Pain scores', 'timeFrame': 'three months', 'description': 'Visual analog scale pain scores, scale 0-10 higher is more pain'}, {'measure': 'Pain scores', 'timeFrame': 'six months', 'description': 'Visual analog scale pain scores, scale 0-10 higher is more pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Tear', 'Knee Injuries', 'Sport Injury']}, 'referencesModule': {'references': [{'pmid': '38035216', 'type': 'DERIVED', 'citation': 'Okoroha KR, Tramer JS, Khalil LS, Jildeh TR, Abbas MJ, Buckley PJ, Lindell C, Moutzouros V. Effects of a Perioperative Blood Flow Restriction Therapy Program on Early Quadriceps Strength and Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2023 Nov 27;11(11):23259671231209694. doi: 10.1177/23259671231209694. eCollection 2023 Nov.'}]}, 'descriptionModule': {'briefSummary': 'Evaluating the use of peri-operative blood flow restriction therapy surrounding anterior cruciate ligament tear', 'detailedDescription': 'The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy both before and after anterior cruciate ligament reconstruction (ACLR) following a tear. BFR has been proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia. Muscle atrophy occurs following ACL tear and reconstruction. Thus, physical therapy is used in the peri-operative period to regain strength with the ultimate goal of returning to activity.\n\nThe goal of this investigation is to determine if using BFR during perioperative therapy would lead to increased and expedited strength gains. Additionally we would like to determine if BFR helps patients to pass the standard rehabilitative functional tests and return to play sooner. We will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding ACL tear and reconstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ACL tear undergoing reconstruction\n\nExclusion Criteria:\n\n* History of pulmonary embolism\n* History of deep vein thrombosis\n* Family history of PE/DVT\n* Hypercoaguable disorder\n* Multiligamentous knee injury\n* Neurovascular injury\n* Peripheral vascular disease\n* Unable to complete physical therapy\n* Unable to tolerate blood flow restriction'}, 'identificationModule': {'nctId': 'NCT04374968', 'briefTitle': 'Use of Blood Flow Restriction Therapy Following ACL Tear', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Anterior Cruciate Ligament Tear', 'orgStudyIdInfo': {'id': '13080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BFR Treatment', 'description': 'Patients will be recruited following ACL tear and medical screening for history of DVT/PE. Patients allocated to the BFR intervention group will undergo physical therapy with the use of a blood flow restriction cuff. Rehabilitation will consist of a structured home exercise program prior to surgery. We will instruct patients on how to perform home BFR and test them in the office to ensure competence. Following surgery patients will immediately be started in physical therapy. Therapy will consist of a structured program progressing from range of motion, to strength training and then functional tests. Both arms will use the same protocol with the only difference being use of BFR.', 'interventionNames': ['Device: Blood flood restriction cuff']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control arm will undergo the same pre and post operative physical therapy as the BFR group. They will undergo a structure home therapy program prior to surgery and an outpatient physical therapy program under the guidance of a therapist following surgery.'}], 'interventions': [{'name': 'Blood flood restriction cuff', 'type': 'DEVICE', 'description': 'Blood flow restriction cuffs will be used as an augment to physical therapy', 'armGroupLabels': ['BFR Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48332', 'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Investigator', 'investigatorFullName': 'Joseph Tramer', 'investigatorAffiliation': 'Henry Ford Health System'}}}}