Complete tear of the anterior cruciate ligament
Conditions
Interventions
Patients with proximal ACL tears will be randomized into two treatment arms:
1. ACL repair (intervention): the torn ACL will be repaired and fixated back to the femoral origin using sutures and a cort
control): the torn ACL will be removed and replaced by a graft from the semitendinosus and gracilis tendons using all-inside drilling and cortical button fixation
Sponsors
Amsterdam UMC
Eligibility
Inclusion criteria
Inclusion criteria: Preoperatively: - Complete primary anterior cruciate ligament injury on physical examination and MRI - Tear in proximal quarter on MRI - Age 18 - 50 - Preinjury Tegner activity level =5 and desired Tegner activity level =5 (otherwise they can be treated non-operatively) - Operation within 4 weeks of injury Intraoperatively: - Sufficient tissue length (proximal tear that can be reattached to insertion site) - Sufficient tissue quality (to withhold repair sutures)
Exclusion criteria
Exclusion criteria: Preoperatively: - Complete ipsilateral concomitant knee ligament injury requiring surgery - Concomitant ipsilateral knee dislocation or patellar dislocation - Osteoarthritis KL grade =2 - Previous ipsilateral ACL reconstruction/repair - Intra-articular corticosteroids 6 months prior - No understanding of Dutch language or not capable of understanding the study and participation - No preoperative flexion of 90 degrees - Grade 3 pivot shift indicating gross ligament instability that requires additional proce-dures - Gross lower leg malalignment requiring bony osteotomies - Muscular, neurological or vascular diseases that influence rehabilitation or surgery - Prolonged use medication use of prednison or cytostatics - Pregnancy during injury or surgery - Osteoporosis that influence rehabilitation or surgery Intraoperatively: - No complete tear at arthroscopy (partial tear or intact ACL) or only partially a proximal tear
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective International Knee Documentation Comitee (IKDC) score at two-year follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Other patient reported outcomes at two-year follow-up: - Knee Injury and Osteoarthritis Outcome Score (KOOS) - Lysholm score - Forgotten Joint Score (FJS) - Patient satisfaction score - Pain score. 2. Objective outcomes at two-year follow-up: - Failure of ACL repair/reconstruction: defined as (traumatic) rerupture or symptomatic instability - Reoperation of the knee for any reason: defined as any new operation on the same knee for any other reason than revision (e.g. symptomatic meniscus tear, hardware irritation, infection or stiffness/arthrofibrosis) - Contralateral ACL injury: defined as a complete rupture of the contralateral ACL - Stability: defined as the laxity found with physical examination using the IKDC objective score, and side-to-side differences using KT-1000 or Rollimeter 3. Return to sports outcomes at two-year follow-up: - Return to sports: defined as returning to sports activities as reported by patients and using the preinjury and postoperative Tegner activity scale - Return to the same sport: defined as returning to the same sports activities as reported by patients and using the preinjury and postoperative Tegner activity scale - Return to preinjury level of sports: defined as returning to sports using the preinjury and postoperative Tegner activity scale - Confidence of return to sports and fear of reinjury: assessed by using the ACL-Return to Sports Index (ACL-RSI) score 4. Osteoarthritis at 10-year follow-up. - Radiographs of both knees will be performed, and the operated knee will be compared to (I) the contralateral knee if no operation occurred in that knee, and (II) the ipsilateral knee radiograph preoperatively. The Kellgren-Lawrence (KL) grade will be used to assess the incidence and grades of osteoarthritis. | — |
Contacts
Public ContactJelle van der List
Amsterdam UMC
Outcome results
None listed