Pilot study to investigate the feasibility of conducting a randomised controlled trial that compares Immediate versus Optional Delayed surgical repair for treatment of acute Anterior cruciate ligament injury: IODA pilot trial

Annemie Smeets, Feryal Ghafelzadeh Ahwaz, Stijn Bogaerts, An De Groef, Pieter Berger, Jean-François Kaux, Christophe Daniel, Jean-Louis Croisier, François Delvaux, Annouschka Laenen, Filip Staes, Koen Peers, Annemie Smeets, Feryal Ghafelzadeh Ahwaz, Stijn Bogaerts, An De Groef, Pieter Berger, Jean-François Kaux, Christophe Daniel, Jean-Louis Croisier, François Delvaux, Annouschka Laenen, Filip Staes, Koen Peers

Abstract

Introduction: Standard care for anterior cruciate ligament (ACL) injuries includes surgical reconstruction of the ACL. However, two randomised controlled trials (RCTs) concluded that conservative treatment does not result in inferior clinical outcomes compared with immediate ACL reconstruction. More research is needed to in the first place verify these results, and second to assess whether patient-specific parameters determine whether a patient would benefit from one treatment option over the other. However, before running a full RCT, it seems necessary to perform a pilot study that assesses the feasibility of recruiting patients with ACL for such a RCT. This is because recruitment may be challenging as many patients have strong treatment beliefs. Therefore, this pilot study will assess whether a large RCT is feasible with regard to participant recruitment, adherence to the allocated treatment arm and protocol feasibility. These pilot findings will help deciding about progressing to a future full RCT.

Methods and analysis: This is a pragmatic, multicentre, randomised controlled pilot trial with two parallel groups. Patients with an acute ACL injury will be recruited from two Belgian hospitals. Patients will be randomised to either conservative treatment or surgical treatment. Patients will be followed-up at 3, 6 and 12 months postrandomisation. Recruitment feasibility will be evaluated by calculating the recruitment rate 4 months after the two sites have been initiated. Clear criteria for progression to a full trial are defined. Adherence to the protocol will be assessed by calculating the proportion of patients who complete the assessments. Furthermore the proportion of patients who cross-over between treatment arms during the follow-up period will be assessed.

Ethics and dissemination: The study was approved by the ethical committees: Ethische Commissie Onderzoek UZ/KU Leuven (S62004) and Comité d'Ethique Hospitalo-Facultaire Universitaire de Liège (2020212). Results will be made available to caregivers, researchers and funder.

Trial registration number: This trial is registered on ClinicalTrials.gov (NCT04408690) on 29 May 2020.

Keywords: orthopaedic sports trauma; rehabilitation medicine; sports medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Trial flow chart. ACL, anterior cruciate ligament; eCRF, electronic case report form; FU, follow-up; V1, visit 1.

References

    1. Sanders TL, Maradit Kremers H, Bryan AJ, et al. . Incidence of anterior cruciate ligament tears and reconstruction: a 21-year population-based study. Am J Sports Med 2016;44:1502–7. 10.1177/0363546516629944
    1. Kobayashi H, Kanamura T, Koshida S, et al. . Mechanisms of the anterior cruciate ligament injury in sports activities: a twenty-year clinical research of 1,700 athletes. J Sports Sci Med 2010;9:669–75.
    1. Lee DW, Lee JH, Kim JN, et al. . Evaluation of anterolateral ligament injuries and concomitant lesions on magnetic resonance imaging after acute anterior cruciate ligament rupture. Arthroscopy 2018;34:2398–406. 10.1016/j.arthro.2018.02.048
    1. Filbay SR, Ackerman IN, Dhupelia S, et al. . Quality of life in symptomatic individuals after anterior cruciate ligament reconstruction, with and without radiographic knee osteoarthritis. J Orthop Sports Phys Ther 2018;48:398–408. 10.2519/jospt.2018.7830
    1. Thorstensson CA, Lohmander LS, Frobell RB, et al. . Choosing surgery: patients’ preferences within a trial of treatments for anterior cruciate ligament injury. A qualitative study. BMC Musculoskelet Disord 2009;9:1–9.
    1. Paterno MV, Rauh MJ, Schmitt LC, et al. . Incidence of second ACL injuries 2 years after primary ACL reconstruction and return to sport. Am J Sports Med 2014;42:1567–73. 10.1177/0363546514530088
    1. Lie MM, Risberg MA, Storheim K, et al. . What's the rate of knee osteoarthritis 10 years after anterior cruciate ligament injury? An updated systematic review. Br J Sports Med 2019;53:1162–7. 10.1136/bjsports-2018-099751
    1. Poulsen E, Goncalves GH, Bricca A, et al. . Knee osteoarthritis risk is increased 4-6 fold after knee injury - a systematic review and meta-analysis. Br J Sports Med 2019;53:1454–63. 10.1136/bjsports-2018-100022
    1. Cinque ME, Dornan GJ, Chahla J, et al. . High rates of osteoarthritis develop after anterior cruciate ligament surgery: an analysis of 4108 patients. Am J Sports Med 2018;46:2011–9. 10.1177/0363546517730072
    1. Wiggins AJ, Grandhi RK, Schneider DK, et al. . Risk of secondary injury in younger athletes after anterior cruciate ligament reconstruction: a systematic review and meta-analysis. Am J Sports Med 2016;44:1861–76. 10.1177/0363546515621554
    1. Ardern CL, Taylor NF, Feller JA, et al. . Fifty-five per cent return to competitive sport following anterior cruciate ligament reconstruction surgery: an updated systematic review and meta-analysis including aspects of physical functioning and contextual factors. Br J Sports Med 2014;48:1543–52. 10.1136/bjsports-2013-093398
    1. Monk AP, Davies LJ, Hopewell S, et al. . Surgical versus conservative interventions for treating anterior cruciate ligament injuries. Cochrane Database Syst Rev 2016;2016:1–38. 10.1002/14651858.CD011166.pub2
    1. Frobell RB, Roos EM, Roos HP, et al. . A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med 2010;363:331–42. 10.1056/NEJMoa0907797
    1. Frobell RB, Roos HP, Roos EM, et al. . Treatment for acute anterior cruciate ligament tear: five year outcome of randomised trial. BMJ 2013;346:f232. 10.1136/bmj.f232
    1. Davies L, Cook J, Leal J, et al. . Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial. Trials 2020;21:1–16. 10.1186/s13063-020-04298-y
    1. Reijman M, Eggerding V, van Es E, et al. . Early surgical reconstruction versus rehabilitation with elective delayed reconstruction for patients with anterior cruciate ligament rupture: COMPARE randomised controlled trial. BMJ 2021;372:n375. 10.1136/bmj.n375
    1. Reijman M. Opereren of even aanzien: goede behandelopties bij kruisbandscheur [Internet], 2019. ZonMW. Available:
    1. von Essen C, McCallum S, Barenius B, et al. . Acute reconstruction results in less sick-leave days and as such fewer indirect costs to the individual and society compared to delayed reconstruction for ACL injuries. Knee Surg Sports Traumatol Arthrosc 2020;28:2044–52. 10.1007/s00167-019-05397-3
    1. Rosso F, Bonasia DE, Cottino U, et al. . Factors affecting subjective and objective outcomes and return to play in anterior cruciate ligament reconstruction: a retrospective cohort study. Joints 2018;6:23–32. 10.1055/s-0038-1636931
    1. Everhart JS, Best TM, Flanigan DC. Psychological predictors of anterior cruciate ligament reconstruction outcomes: a systematic review. Knee Surg Sports Traumatol Arthrosc 2015;23:752–62. 10.1007/s00167-013-2699-1
    1. Paterno MV, Flynn K, Thomas S, et al. . Self-reported fear predicts functional performance and second ACL injury after ACL reconstruction and return to sport: a pilot study. Sports Health 2018;10:228–33. 10.1177/1941738117745806
    1. Kvist J, Ek A, Sporrstedt K, et al. . Fear of re-injury: a hindrance for returning to sports after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc 2005;13:393–7. 10.1007/s00167-004-0591-8
    1. Thomeé P, Währborg P, Börjesson M, et al. . Self-efficacy of knee function as a pre-operative predictor of outcome 1 year after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthr 2008;16:118–27. 10.1007/s00167-007-0433-6
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Wilk KE, Arrigo CA. Rehabilitation principles of the anterior cruciate ligament reconstructed knee: twelve steps for successful progression and return to play. Clin Sports Med 2017;36:189–232. 10.1016/j.csm.2016.08.012
    1. van Melick N, van Cingel REH, Brooijmans F, et al. . Evidence-based clinical practice update: practice guidelines for anterior cruciate ligament rehabilitation based on a systematic review and multidisciplinary consensus. Br J Sports Med 2016;50:1506–15. 10.1136/bjsports-2015-095898
    1. Cavanaugh JT, Powers M. ACL rehabilitation progression: where are we now? Curr Rev Musculoskelet Med 2017;10:289–96. 10.1007/s12178-017-9426-3
    1. Newman-Beinart NA, Norton S, Dowling D, et al. . The development and initial psychometric evaluation of a measure assessing adherence to prescribed exercise: the exercise adherence rating scale (EARS). Physiotherapy 2017;103:180–5. 10.1016/j.physio.2016.11.001
    1. Noyes FR, Barber SD, Mangine RE. Abnormal lower limb symmetry determined by function hop tests after anterior cruciate ligament rupture. Am J Sports Med 1991;19:513–8. 10.1177/036354659101900518
    1. Roemer FW, Frobell R, Lohmander LS, et al. . Anterior cruciate ligament osteoarthritis score (ACLOAS): longitudinal MRI-based whole joint assessment of anterior cruciate ligament injury. Osteoarthritis Cartilage 2014;22:668–82. 10.1016/j.joca.2014.03.006
    1. Moss-Morris R, Weinman J, Petrie K, et al. . The revised illness perception questionnaire (IPQ-R). Psychol Health 2002;17:1–16. 10.1080/08870440290001494
    1. de Raaij EJ, Schröder C, Maissan FJ, et al. . Cross-cultural adaptation and measurement properties of the brief illness perception Questionnaire-Dutch language version. Man Ther 2012;17:330–5. 10.1016/j.math.2012.03.001
    1. Demoulin C, Duvallon L, Roussel N. Traduction en français du « Brief illness perceived questionnaire » adapté aux patients lombalgiques et étude de ses qualités métrologiques. Revue du Rhumatisme 2016:A163–304.
    1. George SZ, Lentz TA, Zeppieri G, et al. . Analysis of shortened versions of the Tampa scale for kinesiophobia and pain catastrophizing scale for patients after anterior cruciate ligament reconstruction. Clin J Pain 2012;28:73–80. 10.1097/AJP.0b013e31822363f4

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