How to Best Treat Anterior Cruciate Ligament Injuries
ConditionAnterior Cruciate Ligament Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-50
SponsorUniversity Hospital, Akershus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Early ACL reconstruction
Procedure/SurgeryACL reconstruction followed by rehabilitation
Active rehabilitation
Procedure/SurgeryNon-operative treatment with active rehabilitation led by a physiotherapist with optional delayed surgery if indicated.
Treatment groups
328 Participants
are divided into 2 treatment groupsGroup A: Early ACL reconstructionActive comparator 1 intervention
Group B: Primary ACL rehabilitationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
at the time of inclusion/surgery, 2 years, 5 years and 10 yearsSecondary outcomes
1
Rate of new meniscal injuries
We want to detect the rate of new meniscal injuries (in the index knee) in the study arm populations.
Time frame
1 year, 2 years, 5 years, 10 years2
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
Time frame
2, 5 and 10 years3
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.
Time frame
2, 5 and 10 years4
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.
Time frame
2, 5 and 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Akershus
Lead sponsor
Norwegian National Knee Ligament Registry
Collaborator
Sorlandet Hospital HF
Collaborator
Kristiansund Hospital
Collaborator
Asker & Baerum Hospital
Collaborator
Source ClinicalTrials.gov