The Best Method for ACL Reconstruction.
1 other identifier
interventional
90
1 country
1
Brief Summary
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. The purpose is:
- 1.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.
- 2.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.
- 3.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.
- 4.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 27, 2017
CompletedFirst Posted
Study publicly available on registry
June 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJuly 11, 2019
July 1, 2019
2.8 years
April 27, 2017
July 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in KNEES-ACL score
patient-reported outcome measure
pre-op, 1 year, 2 years
Secondary Outcomes (3)
Change in anterior-posterior stability (quantified by Rolimeter)
pre-op, 1 year, 2 years
Change in graded pivot shift
pre-op, 1 year, 2 years
Change in muscle strength and forward lunge ability
pre-op, 1 year, 2 years
Study Arms (3)
ACL-reconstruction hamstrings
ACTIVE COMPARATORACL reconstruction hamstrings
ACL-reconstruction patella tendon
ACTIVE COMPARATORACL reconstruction patella tendon
ACL-reconstruction iliotibial tract
ACTIVE COMPARATORACL reconstruction iliotibial tract
Interventions
HG reconstruction is performed according to the standard procedure of the department: A 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
PTBG reconstruction is performed according to the standard procedure of the department: A 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.
TIFLG reconstruction is performed as follows: The 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.
Eligibility Criteria
You may qualify if:
- Patients with an ACL rupture scheduled for ACL reconstruction after clinical investigation by an orthopedic specialist at the Section of Sports Traumatology M51.
- Age 18-40 years.
- Patients able to understand given information in relation to the study and to complete out-come questionnaires.
You may not qualify if:
- 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.
- 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
- Conditions in either knee with pain of such intensity, that participation in the functional tests of this study are impossible.
- Auto-immune disease that involves lower limb joints or muscles.
- Local or systemic infection.
- Actual or previous systemic corticosteroid, chemotherapeutic, or immunosuppressive treatment.
- BMI\>30.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lars Konradsenlead
Study Sites (1)
Bisppebjerg Hospital
Copenhagen, 3400, Denmark
Study Officials
- STUDY DIRECTOR
Michael Krogsgaard
Head of section
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Outcome assessor is not involved in the surgical procedures. Participants wear long trousers at follow-up procedures to mask surgical incisions.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior consultant, clinical professor
Study Record Dates
First Submitted
April 27, 2017
First Posted
June 20, 2017
Study Start
February 1, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2021
Last Updated
July 11, 2019
Record last verified: 2019-07