2025 ISAKOS Biennial Congress ePoster
Soft-Tissue Quadriceps Autograft Acl-Reconstruction In The Skeletally-Immature Vs. Hamstrings (Squash): Feasibility Of A Randomized Controlled Trial.
Darren L. de SA, MD MBA FRCSC, Hamilton, Ontario CANADA
Kanto Nagai, MD, PhD, Kobe, Hyogo JAPAN
Devin Clarke Peterson, MD, FRCSC, Dip Sport Med, Ancaster, Ontario CANADA
Jihad Abouali, MD, FRCSC, Scarborough , Ontario CANADA
Marie-Lyne Nault, MD, PhD, Montreal, Quebec CANADA
Thierry Pauyo, MD, FRCSC, Montreal, QC CANADA
Sasha Carsen, MD CANADA
Olufemi R. Ayeni, MD, PhD, MSc, FRCSC, Hamilton, ON CANADA
McMaster University, Hamilton, Ontario, CANADA
FDA Status Not Applicable
Summary
SQuASH has demonstrated feasibility and safety as one of the largest, international randomized controlled trials in paediatric ACL reconstruction.
ePosters will be available shortly before Congress
Abstract
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings (SQuASH): Feasibility of a Randomized Controlled Trial.
Purpose
This study aims to demonstrate the feasibility of a global randomized controlled clinical trial evaluating the efficacy of soft-tissue quadriceps versus hamstring autograft tendons on re-operation, return-to-sport, and knee function among skeletally-immature, paediatric patients undergoing primary ACL reconstruction.
Methods
A total 100 patients, aged 10-18 years inclusive, who are skeletally-immature at the time of their injury, and undergoing arthroscopic-assisted, single-bundle primary ACL reconstruction will be randomized into two autograft treatment arms: 1) soft-tissue quadriceps or 2) hamstring tendon. The primary outcome of interest is the rate of re-operation within the first two years post-operatively, with several secondary outcomes within the same time frame including: rate of return-to-sport; patient-reported knee function; range of motion; incidence of physeal injury and its sequelae; and degrees of persistent anterior-posterior and rotatory laxity.
Results
To date, six international sites (one Japan, five Canada) have recruited 100 patients. Baseline demographics entail: 64.0% male, 54% right knees, mean (SD) BMI of 22.5 (4.9) and mean (SD) age 14.5 (1.5) years. Overall, 89% of injuries were traumatic in-nature, and pre-operatively, patients had a mean (SD) Tegner Activity Score of 6.5 (2.5). Interim analyses of the outcomes data are not planned as per study protocol to prevent adjustment of the nominal P value. Nevertheless, the trial has successfully completed several Data Safety and Monitoring Board meetings, and no safety concerns were identified. From a feasibility perspective, the trial has been a resounding success, achieving a 90% follow-up rate, 94% case-report form completion rate, 1% cross-over rate, and 100% recruitment rate.
Discussion
The use of the quadriceps tendon as an autograft option in primary paediatric Anterior Cruciate Ligament (ACL) reconstruction has not been well studied. The 2018 International Olympic Committee (IOC) Consensus Statement now outlines the quadriceps tendon as a possible autograft option. However, no Randomized Controlled Trials (RCT) have examined the efficacy of the quadriceps tendon autograft in the skeletally-immature compared to the historical "gold-standard" soft-tissue hamstring autograft. Considering its evidence for favourable outcomes in the adult population, and the (albeit limited) evidence showing safety and promise in the paediatric population, clinical equipoise exists for assessing its impact on outcomes in this patient population at the index surgery. SQuASH currently represents one of the largest, international randomized controlled trials in this realm, and thus far, has demonstrated feasibility and safety. Future plans entail moving toward the definitive trial of 352 patients.