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How to Best Treat Anterior Cruciate Ligament Injuries

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ClinicalTrials.gov Identifier: NCT04770233
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : February 3, 2022
Sponsor:
Collaborators:
Norwegian National Knee Ligament Registry
Sorlandet Hospital HF
Kristiansund Hospital
Asker & Baerum Hospital
Information provided by (Responsible Party):
Guri Ranum Ekås, University Hospital, Akershus

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injuries Procedure: Early ACL reconstruction Procedure: Active rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Registry-based multi-center RCT. Centralized randomization through NNKLR stratified by participating centers. Allocation concealment secured by requiring registration into the NNKLR and the R-RCT before allocation is revealed.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving the Treatment of Anterior Cruciate Ligament Tears in Norway With Register-RCTs - Who Should Have Surgery
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : December 2045

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Early ACL reconstruction
Early ACL reconstruction is performed within 12 weeks after ACL injury and is followed by rehabilitation led by a physiotherapist. ACL surgical technique and rehabilitation is pragmatic according to the routines at the including centre.
Procedure: Early ACL reconstruction
ACL reconstruction followed by rehabilitation
Other Name: ACL surgery

Active Comparator: Primary ACL rehabilitation

Primary ACL rehabilitation is active rehabilitaion led by a physiotherapist. Active rehabilitation will begin as early as possible after the ACL injury. The goal of rehabilitation is to stabilized the knee without an operation.

ACL reconstruciton is still an option after 6 months if the knee is unstable or do not allow adequat return to physical activity. If the patient sustain new knee injuries secondary to the ACL injury or has major instability, ACL reconstruction may be necessary before 6 months. The patients randomized to active rehabilitation will be routinely followed-up at his/her local hospital at 6 months.

Procedure: Active rehabilitation
Non-operative treatment with active rehabilitation led by a physiotherapist with optional delayed surgery if indicated.
Other Name: Non-operative treatment, physiotherapy, physical therapy




Primary Outcome Measures :
  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 [ Time Frame: at the time of inclusion/surgery, 2 years, 5 years and 10 years ]
    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.


Secondary Outcome Measures :
  1. Rate of new meniscal injuries [ Time Frame: 1 year, 2 years, 5 years, 10 years ]
    We want to detect the rate of new meniscal injuries (in the index knee) in the study arm populations.

  2. Rate of subsequent knee surgery to the index knee [ Time Frame: 2, 5 and 10 years ]
    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

  3. Mean change in additional KOOS-subscales from baseline to follow-up [ Time Frame: 2, 5 and 10 years ]
    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.

  4. Rate of subsequent treatment of an ACL-tear of the contralateral knee [ Time Frame: 2, 5 and 10 years ]
    We want to detect the rate of new ACL injuries and treatment to the other knee.

  5. Rate of return to preinjury activity level [ Time Frame: 2, 5 and 10 years ]
    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.



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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770233


Contacts
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Contact: Rune Jakobsen, PhD/MD 92092973 ext +47 r.b.jakobsen@medisin.uio.no
Contact: Guri Ekås, PhD/MD 93617315 ext +47 g.r.ekas@medisin.uio.no

Locations
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Norway
Orthopedic Department, Akershus University Hospital Recruiting
Lørenskog, Viken, Norway, 1478
Contact: Guri Ekås, PhD    93617315 ext +47    g.r.ekas@medisin.uio.no   
Contact: Rune Jakobsen, PhD/MD         
Orthopedic division, Oslo University Hospital Recruiting
Oslo, Norway, 0850
Contact: Lars Engebretsen, PhD/MD         
Contact: Caroline Tveiten, MD         
Sponsors and Collaborators
University Hospital, Akershus
Norwegian National Knee Ligament Registry
Sorlandet Hospital HF
Kristiansund Hospital
Asker & Baerum Hospital
Investigators
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Study Chair: Rune Jakobsen, PhD/MD Akershus University Hospital, University of Oslo
Publications:

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Responsible Party: Guri Ranum Ekås, Consultant, Orthopedic Surgeon, Researcher, Assistant professor (MD/PhD), University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT04770233    
Other Study ID Numbers: REC148805
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guri Ranum Ekås, University Hospital, Akershus:
acl
anterior cruciate ligament injury
anterior cruciate ligament rupture
anterior cruciate ligament tear
secondary meniscal tear
ACL reconstruction
ACL rehabilitation
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries