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

Abstract

IntroductionAnterior 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 analysisThis 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 disseminationEthics 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 numberACTRN12618000762257p.