How to Best Treat Anterior Cruciate Ligament Injuries

NCT04770233 | Recruiting DMC

• 1 other identifier: REC148805
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 2

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.

Conditions

Anterior Cruciate Ligament Injuries

Keywords

acl; anterior cruciate ligament injury; anterior cruciate ligament rupture; anterior cruciate ligament tear; secondary meniscal tear; ACL reconstruction; ACL rehabilitation

Outcome Measures

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.

  at the time of inclusion/surgery, 2 years, 5 years and 10 years

Secondary Outcomes (5)

• Rate of new meniscal injuries

  1 year, 2 years, 5 years, 10 years

• Rate of subsequent knee surgery to the index knee

  2, 5 and 10 years

• Mean change in additional KOOS-subscales from baseline to follow-up

  2, 5 and 10 years

• Rate of subsequent treatment of an ACL-tear of the contralateral knee

  2, 5 and 10 years

• Rate of return to preinjury activity level

  2, 5 and 10 years

Study Arms (2)

Early ACL reconstruction

ACTIVE COMPARATOR

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

Primary ACL rehabilitation

ACTIVE COMPARATOR

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

Interventions

Early ACL reconstruction PROCEDURE

ACL reconstruction followed by rehabilitation

Also known as: ACL surgery

Early ACL reconstruction

Active rehabilitation PROCEDURE

Non-operative treatment with active rehabilitation led by a physiotherapist with optional delayed surgery if indicated.

Also known as: Non-operative treatment, physiotherapy, physical therapy

Primary ACL rehabilitation

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Elite athletes (Tegner 10) in pivoting sports and patients with additional knee injuries warranting repair

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Norwegian National Knee Ligament Registry: collaborator
• Sorlandet Hospital HF: collaborator
• Kristiansund Hospital: collaborator
• Asker & Baerum Hospital: collaborator

Study Sites (2)

Orthopedic Department, Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

RECRUITING

Orthopedic division, Oslo University Hospital

Oslo, 0850, Norway

RECRUITING

Related Publications (18)

• Ytterstad K, Granan LP, Engebretsen L. [The Norwegian Cruciate Ligament Registry has a high degree of completeness]. Tidsskr Nor Laegeforen. 2011 Feb 4;131(3):248-50. doi: 10.4045/tidsskr.10.0536. Norwegian.

  PMID: 21304574 BACKGROUND

• Spindler KP, Wright RW. Clinical practice. Anterior cruciate ligament tear. N Engl J Med. 2008 Nov 13;359(20):2135-42. doi: 10.1056/NEJMcp0804745. No abstract available.

  PMID: 19005197 BACKGROUND

• Granan LP, Engebretsen L, Bahr R. [Surgery for anterior cruciate ligament injuries in Norway]. Tidsskr Nor Laegeforen. 2004 Apr 1;124(7):928-30. Norwegian.

  PMID: 15060639 BACKGROUND

• Ingelsrud LH, Terwee CB, Terluin B, Granan LP, Engebretsen L, Mills KAG, Roos EM. Meaningful Change Scores in the Knee Injury and Osteoarthritis Outcome Score in Patients Undergoing Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2018 Apr;46(5):1120-1128. doi: 10.1177/0363546518759543. Epub 2018 Mar 8.

  PMID: 29517924 BACKGROUND

• Engebretsen L, Forssblad M, Lind M. Why registries analysing cruciate ligament surgery are important. Br J Sports Med. 2015 May;49(10):636-8. doi: 10.1136/bjsports-2014-094484. Epub 2015 Feb 2. No abstract available.

  PMID: 25807159 BACKGROUND

• Seil R, Mouton C, Theisen D. How to get a better picture of the ACL injury problem? A call to systematically include conservatively managed patients in ACL registries. Br J Sports Med. 2016 Jul;50(13):771-2. doi: 10.1136/bjsports-2015-095027. Epub 2015 Sep 23. No abstract available.

  PMID: 26400957 BACKGROUND

• Krumholz HM. Registries and selection bias: the need for accountability. Circ Cardiovasc Qual Outcomes. 2009 Nov;2(6):517-8. doi: 10.1161/CIRCOUTCOMES.109.916601. No abstract available.

  PMID: 20031886 BACKGROUND

• Ekas GR, Engebretsen L. [The cruciate ligament register--due for a change?]. Tidsskr Nor Laegeforen. 2016 Feb 23;136(4):298. doi: 10.4045/tidsskr.15.1291. eCollection 2016 Feb 23. No abstract available. Norwegian.

  PMID: 26905841 BACKGROUND

• Lauer MS, D'Agostino RB Sr. The randomized registry trial--the next disruptive technology in clinical research? N Engl J Med. 2013 Oct 24;369(17):1579-81. doi: 10.1056/NEJMp1310102. Epub 2013 Aug 31. No abstract available.

  PMID: 23991657 BACKGROUND

• Mathes T, Buehn S, Prengel P, Pieper D. Registry-based randomized controlled trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials. J Clin Epidemiol. 2018 Jan;93:120-127. doi: 10.1016/j.jclinepi.2017.09.017. Epub 2017 Sep 22.

  PMID: 28951111 BACKGROUND

• Sims AL, Parsons N, Achten J, Griffin XL, Costa ML, Reed MR; CORNET trainee collaborative. A randomized controlled trial comparing the Thompson hemiarthroplasty with the Exeter polished tapered stem and Unitrax modular head in the treatment of displaced intracapsular fractures of the hip: the WHiTE 3: HEMI Trial. Bone Joint J. 2018 Mar 1;100-B(3):352-360. doi: 10.1302/0301-620X.100B3.BJJ-2017-0872.R2.

  PMID: 29589786 BACKGROUND

• Yndigegn T, Hofmann R, Jernberg T, Gale CP. Registry-based randomised clinical trial: efficient evaluation of generic pharmacotherapies in the contemporary era. Heart. 2018 Oct;104(19):1562-1567. doi: 10.1136/heartjnl-2017-312322. Epub 2018 Apr 17.

  PMID: 29666176 BACKGROUND

• Frobert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angeras O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Karegren A, Nilsson J, Robertson L, Sandhall L, Sjogren I, Ostlund O, Harnek J, James SK; TASTE Trial. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013 Oct 24;369(17):1587-97. doi: 10.1056/NEJMoa1308789. Epub 2013 Aug 31.

  PMID: 23991656 BACKGROUND

• Frobell RB, Lohmander LS, Roos EM. The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment. Contemp Clin Trials. 2007 May;28(3):295-302. doi: 10.1016/j.cct.2006.10.002. Epub 2006 Oct 6.

  PMID: 17137844 BACKGROUND

• Eitzen I, Holm I, Risberg MA. Preoperative quadriceps strength is a significant predictor of knee function two years after anterior cruciate ligament reconstruction. Br J Sports Med. 2009 May;43(5):371-6. doi: 10.1136/bjsm.2008.057059. Epub 2009 Feb 17.

  PMID: 19224907 BACKGROUND

• Pandis N. Randomization. Part 2: Minimization. Am J Orthod Dentofacial Orthop. 2011 Dec;140(6):902-4. doi: 10.1016/j.ajodo.2011.08.016. No abstract available.

  PMID: 22133958 BACKGROUND

• FAITH Investigators. Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures. BMC Musculoskelet Disord. 2014 Jun 26;15:219. doi: 10.1186/1471-2474-15-219.

  PMID: 24965132 BACKGROUND

• Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.

  PMID: 14613558 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Rune Jakobsen, PhD/MD

  Akershus University Hospital, University of Oslo

  STUDY CHAIR

Central Study Contacts

Rune Jakobsen, PhD/MD

CONTACT

92092973; r.b.jakobsen@medisin.uio.no

Guri Ekås, PhD/MD

CONTACT

93617315; g.r.ekas@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Orthopedic Surgeon, Researcher, Assistant professor (MD/PhD)

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: April 29, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2045
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)