Anterior Cruciate Ligament Injuries Clinical Trial
Official title:
Improving the Treatment of Anterior Cruciate Ligament Tears in Norway With Register-RCTs - Who Should Have Surgery
NCT number | NCT04770233 |
Other study ID # | REC148805 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 29, 2021 |
Est. completion date | December 2045 |
The project is a pragmatic registry-based RCT aiming to investigate ACL injury treatment. Study results will help fill knowledge gaps, facilitate shared decision making and strengthen patient treatment. Included patients will be randomized to (1) early ACL surgery followed by rehabilitation or (2) active rehabilitation with optional delayed surgery if indicated. Randomization and data collection is conducted through the Norwegian National Knee Ligament Registry (NNKLR) which is a well established population based ACL registry. Participation is based on informed consent to participate in the NNKLR and the registry-based RCT. The study uses the platform and outcome measures of the NNKLR to collect and measure data. The data will be stored as usual in the NNKLR, but RCT specific data will be exported for analysis and stored inTjenester for sensitive data (TSD). Data collected in NNKLR are: patient data (age, height, weight, activity level, smoking-and snuff habits), knee injury data (injury data, injury mechanism, additional knee injury), treatment (non-operative or ACL reconstruction, reoperation), surgical details (operation date, antibiotics, anti-coagulants, graft type and size, approach for femoral tunnel, additional injury and additional surgical procedure) and patient reported knee function at baseline, 2, 5 and 10 years. Also, x-rays and MRIs will be imported for included patients and stored in TSD.
Status | Recruiting |
Enrollment | 328 |
Est. completion date | December 2045 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 50 Years |
Eligibility | Inclusion Criteria: - Patients who have sustained an acute ACL injury (must be possible to perform the "early surgery" treatment option within 12 weeks) - Age 16-50 years and skeletally mature - No previous surgery in the index knee or knee injury which influences rehabilitation - Patient capable to undergo both surgery and rehabilitation Exclusion Criteria: • Elite athletes (Tegner 10) in pivoting sports and patients with additional knee injuries warranting repair |
Country | Name | City | State |
---|---|---|---|
Norway | Orthopedic Department, Akershus University Hospital | Lørenskog | Viken |
Norway | Orthopedic division, Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Akershus | Asker & Baerum Hospital, Kristiansund Hospital, Norwegian National Knee Ligament Registry, Sorlandet Hospital HF |
Norway,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mean change in the score for Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales: Knee Related Quality of Life and Sports and Recreational Function from baseline to 2, 5 and 10 years after inclusion | Knee Injury and Osteoarthritis Outcome Score (KOOS) is a gold standard for patient reported outcome measures for knee injuries and knee osteoarthrities. This score has five subscales: pain, symptoms, function in daily living, function in sports and recreation and quality of life. Each subscale is calculated separately from 0-100. A score of 100 represent the best score possible, indicating no symptoms and a score of 0 is the worst possible score indicating extreme symptoms. | at the time of inclusion/surgery, 2 years, 5 years and 10 years | |
Secondary | Rate of new meniscal injuries | We want to detect the rate of new meniscal injuries (in the index knee) in the study arm populations. | 1 year, 2 years, 5 years, 10 years | |
Secondary | Rate of subsequent knee surgery to the index knee | We want to detect the rate and type of resurgeries to the study arm populations e.g. meniscal surgery, revision ACL surgery, debridement due to infection | 2, 5 and 10 years | |
Secondary | Mean change in additional KOOS-subscales from baseline to follow-up | We want to detect mean changes in the subscales Pain, Symptoms and Activities of daily living. Each subscale is calculated separately from 0-100. A score of 100 represent the best score possible, indicating no symptoms and a score of 0 is the worst possible score indicating extreme symptoms. | 2, 5 and 10 years | |
Secondary | Rate of subsequent treatment of an ACL-tear of the contralateral knee | We want to detect the rate of new ACL injuries and treatment to the other knee. | 2, 5 and 10 years | |
Secondary | Rate of return to preinjury activity level | We want to detect the rate of patients returning to preinjury activity level after ACL injury. Activity level is based on al Hefti's scale 1-4 according to degree of pivoting. Level 1 is pivoting sport such as soccer, basket ball, team handball, floorball, rugby. Level 2 is sports with some pivoting such as tennis, squash, alpine skiing, twin tip skiing, martial arts, dancing. Level 3 is sports without pivoting such as cycling, running, strength training, swimming, spinning, cross-country skiing. Level 4 is no sports activity. | 2, 5 and 10 years |
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