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  • Study protocol for double-blind, randomised placebo-controlled trial evaluating semitendinosus function and morbidity following tendon harvesting for anterior cruciate ligament reconstruction augmented by platelet-rich plasma

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Rehabilitation medicine
Protocol
Study protocol for double-blind, randomised placebo-controlled trial evaluating semitendinosus function and morbidity following tendon harvesting for anterior cruciate ligament reconstruction augmented by platelet-rich plasma
  1. William du Moulin1,2,
  2. Adam Kositsky1,2,
  3. Matthew N Bourne1,2,
  4. Laura E Diamond1,2,
  5. Francois Tudor3,
  6. Christopher Vertullo2,4,
  7. David J Saxby1,2
  1. 1School of Health Sciences and Social Work, Griffith University - Gold Coast Campus, Southport, Queensland, Australia
  2. 2Griffith Centre of Biomedical and Rehabilitation Engineering (GCORE), Gold Coast, Queensland, Australia
  3. 3Orthopaedics, Gold Coast University Hospital Network, Gold Coast, Queensland, Australia
  4. 4Knee Research Australia, Gold Coast, Queensland, Australia
  1. Correspondence to William du Moulin; will.dumoulin{at}griffithuni.edu.au

Abstract

Introduction Anterior cruciate ligament (ACL) rupture is debilitating, often requiring surgical reconstruction. An ACL reconstruction (ACLR) using a tendon autograft harvested from the semitendinosus results in substantial injury to the donor muscle. Following ACLR, patients rarely return to their preinjury level of physical activity, are at elevated risk of secondary lower limb injuries and early onset knee osteoarthritis. To date, no randomised controlled trial has evaluated the efficacy of platelet-rich plasma (PRP) in aiding knee function and semitendinosus morphology of following ALCR.

Methods and analysis This is a multicentre double-blind randomised placebo-controlled trial. Fifty-four ACLR patients aged 18–50 years will be randomised to receive either a single application of PRP (ACLR+) or placebo saline (ACLR) into the semitendinosus harvest zone at the time of surgery. All patients will undergo normal postoperative rehabilitation recommended by the attending orthopaedic surgeon or physiotherapist. The primary outcome measure is between-limb difference (ACLR compared with intact contralateral) in isometric knee flexor strength at 60o knee flexion, collected 10–12 months postsurgery. This primary outcome measure will be statistically compared between groups (ACLR+ and standard ACLR). Secondary outcome measures include bilateral assessments of hamstring muscle morphology via MRI, biomechanical and electromyographic parameters during an anticipated 45° running side-step cut and multidirectional hopping task and patient-reported outcomes questionaries. Additionally, patient-reported outcomes questionaries will be collected before (baseline) as well as immediately after surgery, and at 2–6 weeks, 3–4 months, 10–12 months and 22–24 months postsurgery 10–12 months following surgery.

Ethics and dissemination Ethics approval has been granted by Griffith University Human Research Ethics Committee, Greenslopes Research and Ethics Committee, and Royal Brisbane & Women’s Hospital Human Research Ethics Committee. Results will be submitted for publication in a peer-reviewed medical journal.

Trial registration number ACTRN12618000762257p.

  • orthopaedic sports trauma
  • knee
  • rehabilitation medicine
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2022-061701

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    Footnotes

    • Twitter @lauradiamond5

    • Contributors WdM was responsible for responsible for study design conceptualisation and manuscript development. AK contributed to study design and manuscript development. MB and LED contributed study design conceptualisation, study oversight and, to reviewing and editing of the manuscript. FT and CV contributed to study design conceptualisation, study oversight, listed as principal site investigator and, to reviewing and editing of the manuscript. DS contributed to study design conceptualisation, study oversight, listed as the chief coordinating investigator and, to reviewing and editing of the manuscript. All authors read and approved the final version of this manuscript and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All persons designated as authors qualify for authorship, and all those who qualify for authorship are listed.

    • Funding This trial is being supported in collaboration with Arthrex on an Australian Research Council Industrial Training and Transformation Centre grant: Centre for Medical Implant Technology. Grant number: IC180100024.

    • Competing interests FT has given paid presentations for Smith & Nephew (Australia) and 3M Medical Solutions (Australia). CV: Director and Treasurer, Australian Orthopaedic Association. President of the Australian Knee Society.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.