Anterior cruciate ligament rupture of the knee Skin and Connective Tissue Diseases Anterior Cruciate Ligament (ACL)
Conditions
Interventions
Surgery and structured rehabilitation compared with structured rehabilitation only.
Sponsors
Lund University Medical Faculty (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-35 at entry 2. A history of a knee sprain not more than 4 weeks before inclusion 3. An ACL insufficiency as determined by clinical examination (positive Lachman test and positive pivot shift) and a complete ACL tear as visualized on Magnetic Resonance Imaging (MRI) 4. Activity level 5-9 by Tegner classification 5. A plain radiographic examination with normal joint status or with a small avulsed lateral fragment or grade 1 osteophyte or grade 1 joint space narrowing as determined by the Osteoarthritis Research Society International (OARSI) atlas
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Earlier major knee injury or knee surgery other than diagnostic arthroscopy on either knee 3. One of the following associated injuries on either knee: 3.1. Grade III medial collateral ligament injury 3.2. An injury to the lateral/posterolateral ligament complex with significantly increased laxity 3.3. Posterior Cruciate Ligament (PCL) injury 3.4. An unstable meniscus tear that requires repair and post-operative treatment interfering with the rehabilitation protocol 3.5. Bi-compartmental extensive meniscus resections 4. A cartilage injury representing a full thickness loss down to bone visualized on MRI 5. Joint space narrowing (JSN) grade 1 combined with osteophytes or JSN grade 2 or greater in the index or contralateral knee as classified by the OARSI atlas 6. A history of deep vein thrombosis (DVT) or a disorder of the coagulative system 7. Refusing to undergo radiological or surgical interventions due to claustrophobia, etc. 8. General disease that affects physical function or systemic medication/abuse of steroids 9. Any other condition or treatment interfering with the completion of the trial, including patients with metal devices or motion disorders etc. that will be unable to complete MRI examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. KOOS and SF-36 patient-administered questionnaire scores, and number of treatment failures at 2 and 5 years 2. Number and grade of joint changes, including bone marrow and meniscus lesions, assessed by radiographs and MRI at 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Knee joint laxity, physical activity level, and molecular markers of joint tissue turnover | — |
Countries
Sweden
Outcome results
None listed