Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-01-31 @ 5:44 PM
Study NCT ID:
NCT03192761
Status:
UNKNOWN
Last Update Posted:
2019-07-11
First Post:
2017-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Best Method for ACL Reconstruction.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessor is not involved in the surgical procedures. Participants wear long trousers at follow-up procedures to mask surgical incisions.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'When the patient has been anaesthetized for surgery, the method of reconstruction is defined by opening a sealed envelope in the operating theatre.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2017-04-27', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in KNEES-ACL score', 'timeFrame': 'pre-op, 1 year, 2 years', 'description': 'patient-reported outcome measure'}], 'secondaryOutcomes': [{'measure': 'Change in anterior-posterior stability (quantified by Rolimeter)', 'timeFrame': 'pre-op, 1 year, 2 years', 'description': 'Measure of anterio-posterior laxity'}, {'measure': 'Change in graded pivot shift', 'timeFrame': 'pre-op, 1 year, 2 years', 'description': 'Subluxation of the tibia relative to the femur'}, {'measure': 'Change in muscle strength and forward lunge ability', 'timeFrame': 'pre-op, 1 year, 2 years', 'description': 'Result of muscle power and muscle coordination tests'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Reconstruction']}, 'descriptionModule': {'briefSummary': 'The investigators wish to compare 3 methods for reconstruction of the anterior cruciate ligament using 3 different grafts: bone-patella tendon-bone, hamstrings and iliotibial tract graft, as these methods influence the muscles around the knee differently. Methods using bone-patella tendon-bone and hamstrings are performed as standard operations, and the use of the iliotibial tract graft using a new method of reconstruction.\n\nThe purpose is:\n\n1. To assess whether one of three different grafts used for reconstruction of the ACL shows superior results compared to the others in relation to mechanical stability and re-rupture rates.\n2. To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others in subjective patient outcome measures.\n3. To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others when considering specific symptoms and complications that can be related to donor-site morbidity.\n4. To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others when considering muscular power, muscle coordination, and function.', 'detailedDescription': 'The purpose of the study is described in the "Brief Summary" section.\n\nPatients scheduled for ACL reconstruction at the Section of Arthroscopic Surgery and Sports Traumatology M51, Department of Orthopedics, Bispebjerg-Frederiksberg Hospital are eligible for this study Eligibility criteria are described in the "Eligibility" section.\n\nThe patients are scheduled for ACL surgery at consultation with a doctor from the Section of Arthroscopic Surgery and Sports Traumatology after usual, clinical criteria. The doctor informs the patient about the project, gives the patient the written patient information, and if the patient shows interest in the study, an appointment is scheduled with one of the surgeons involved in the project.\n\nAt this appointment the patient is informed about the project by the surgeon. The patients will be granted the reflection time they need before consenting or rejecting.\n\nBefore the day of surgery muscle power, muscle coordination and functional tests are performed, and objective tests and PROMs are completed.\n\nSurgery is performed by one of two surgeons experienced in all three methods of surgery as described in the "Arms and Interventions" section.\n\nAfter the patient is put under general anaesthesia the method of ACL reconstruction is chosen by opening a sealed envelope.\n\nOutcome measures are recorded at 1-year and 2-year follow-up.\n\nAll three methods of reconstruction are believed to have the same risk for basic complications: infection (approx. 1%), stiffening of the knee (approx. 2%) and deep venous thrombosis (approx. 1 %)\n\nIt is assumed that a 20% difference in a patient reported outcome score (KNEES-ACL) represents a clinically relevant difference. Based on standard deviations for the outcome score, and with a 90% power, significant differences of 20 % can be shown in a sample of 20 patients. Significance level is set at 5%. The investigators aim for 30 patients in each group, considering potential drop-outs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an ACL rupture scheduled for ACL reconstruction after clinical investigation by an orthopedic specialist at the Section of Sports Traumatology M51.\n* Age 18-40 years.\n* Patients able to understand given information in relation to the study and to complete out-come questionnaires.\n\nExclusion Criteria:\n\n* Patient activity (sports or work) that excludes one or more of the three methods of surgery, e.g. work predominantly performed kneeling would exclude the use of the BPTBG.\n* Other ligament injuries (except non-surgically treated lesion of MCL - medial collateral ligament) to the same knee or ligament injury (except non-surgically treated lesion of MCL - medial collateral ligament) to the contralateral knee\n* Conditions in either knee with pain of such intensity, that participation in the functional tests of this study are impossible.\n* Auto-immune disease that involves lower limb joints or muscles.\n* Local or systemic infection.\n* Actual or previous systemic corticosteroid, chemotherapeutic, or immunosuppressive treatment.\n* BMI\\>30.'}, 'identificationModule': {'nctId': 'NCT03192761', 'briefTitle': 'The Best Method for ACL Reconstruction.', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'The Best Method for ACL Reconstruction. A Study Comparing Reconstructions of Anterior Cruciate Ligament Using Grafts Taken From Three Different Anatomical Locations at the Knee and Thigh. A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'BBH-ACL-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACL-reconstruction hamstrings', 'description': 'ACL reconstruction hamstrings', 'interventionNames': ['Procedure: ACL reconstruction hamstrings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ACL-reconstruction patella tendon', 'description': 'ACL reconstruction patella tendon', 'interventionNames': ['Procedure: ACL reconstruction patella tendon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ACL-reconstruction iliotibial tract', 'description': 'ACL reconstruction iliotibial tract', 'interventionNames': ['Procedure: ACL reconstruction iliotibial tract']}], 'interventions': [{'name': 'ACL reconstruction hamstrings', 'type': 'PROCEDURE', 'description': 'HG reconstruction is performed according to the standard procedure of the department:\n\nA double semi-Tendinosus and gracillis graft is used. Placement of the bony tunnels is anatomical, and the femoral tunnel is positioned through the antero-medial portal. Fixation proximally is by CL-endobutton and at the tibia by Intrafix sheet and screw', 'armGroupLabels': ['ACL-reconstruction hamstrings']}, {'name': 'ACL reconstruction patella tendon', 'type': 'PROCEDURE', 'description': 'PTBG reconstruction is performed according to the standard procedure of the department:\n\nA bone patella tendon bone graft of 1 cm width from the midportion of the tendon is used. Placement of the bony tunnels is anatomical, the femoral being positioned through the antero-medial portal. Fixation proximally and distally is by interference screws.', 'armGroupLabels': ['ACL-reconstruction patella tendon']}, {'name': 'ACL reconstruction iliotibial tract', 'type': 'PROCEDURE', 'description': 'TIFLG reconstruction is performed as follows:\n\nThe TIFL graft is harvested using two lateral incisions. The graft is left attached to the distal iliotibial tract. Placement of the bony tunnels is anatomical, the femoral being drilled outside-in. The tibial drill tunnel is made by retrograde drilling 20 mm, leaving cortical bone at the distal end of the tunnel. Fixation distally is by CL-endobutton or interference screw and on femur by an interference screw outside-in.', 'armGroupLabels': ['ACL-reconstruction iliotibial tract']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Michael Krogsgaard', 'role': 'CONTACT', 'email': 'Michael.Krogsgaard@regionh.dk', 'phone': '+4520512714'}], 'facility': 'Bisppebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Lars Konradsen', 'role': 'CONTACT', 'email': 'Lars.Konradsen@Regionh.dk', 'phone': '+4540284517'}, {'name': 'Michael Krogsgaard', 'role': 'CONTACT', 'email': 'Michael.Krogsgaard@regionh.dk', 'phone': '+4520512714'}], 'overallOfficials': [{'name': 'Michael Krogsgaard', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of section'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Yes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lars Konradsen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior consultant, clinical professor', 'investigatorFullName': 'Lars Konradsen', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}