Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature Vs. Hamstrings (SQuASH)

Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature Vs. Hamstrings (SQuASH): a Multi-Centre Randomized Controlled Trial

To date, 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 Randomised Control Trial (RCT) has examined the efficacy of the quadriceps tendon autograft in primary paediatric ACL reconstruction compared to the historical "gold-standard" soft-tissue hamstring autograft in this population. In light of 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 paediatric patients at the index surgery. This is a parallel, international, multi-centre, blinded randomized controlled trial of 352 skeletally-immature (at the time of injury) patients (ages 10-18 years, inclusive) undergoing primary ACL reconstruction to compare the effect of autograft tendon choice (i.e. hamstring versus soft-tissue quadriceps) on the rates of ACL graft failure, return-to-sport, knee function, pain, health-related quality of life and health utility, psychological factors, range of motion and stability, and any other adverse events at 24 months.

Study Overview

• Status: Recruiting
• Conditions: ACL - Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Procedure: Soft tissue hamstring autograft; Procedure: Quadriceps tendon autograft

• Study Type: Interventional
• Enrollment (Estimated): 352
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole Simunovic, MSc; Phone Number: (289) 237-3224; Email: simunon@mcmaster.ca
• Study Contact Backup: Name: Darren de SA, MD, FRCSC; Phone Number: 9059232126; Email: darren.desa@medportal.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N3Z5
      • Recruiting
      • McMaster University
      • Contact: Nicole Simunovic, MSc; Phone Number: (289) 237-3224; Email: simunon@mcmaster.ca
      • Contact: Darren de SA, MSc; Email: darren.desa@medportal.ca
      • Contact: Darren de SA, MD
      • Contact: Olufemi R Ayeni, MD, PhD
      • Contact: Devin C Peterson, MD
    • Ottawa, Ontario, Canada, K1H 8L1
      • Recruiting
      • Children's Hospital of Eastern Ontario
      • Contact: Sasha Carsen, MD
    • Toronto, Ontario, Canada, M5S 1B2
      • Recruiting
      • Women's College Hospital/Research Institute
      • Contact: Ananya Pathak, MSc
      • Contact: Jihad Abouali, MD, FRCSC
  • Quebec
    • Montréal, Quebec, Canada, H3T 1C5
      • Recruiting
      • CHU Sainte-Justine
      • Contact: Nathalie Jourdain
      • Contact: Marie-Lyne Nault, MD, FRCSC
    • Montréal, Quebec, Canada, H4A 0A9
      • Recruiting
      • Shriners Hospitals for Children - Canada
      • Contact: Nicolas Herrera, MSc
      • Contact: Justin Drager, MD, FRCSC
• Japan
  • Kobe, Japan
    • Recruiting
    • Kobe University
    • Contact: Kanto Nagai, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Patients aged 10-18 years.
2. History, physical exam, and magnetic resonance imaging (MRI) or arthroscopic image confirmation of ACL insufficiency.
3. Suitable for anatomic, single-bundle arthroscopic-assisted ACL reconstruction.
4. X-ray or MRI evidence of skeletal immaturity (i.e., open physes) based on imaging that is closest to the time of injury (and correlated with standard bone age left hand posteroanterior (PA) radiographs).
5. Patient involved in sport (competitive and/or recreational level) prior to injury.
6. Patient and parent/guardian speak, read, and understand the language of the clinical site.
7. Patient and parent/guardian provide informed consent and/or assent.

Exclusion Criteria

1. Evidence (i.e. radiographic and/or arthroscopic) of International Cartilage Repair Society (ICRS) Cartilage Lesion Classification System Grade 2 (i.e., lesions extending down to 50% of the cartilage depth) and higher osteoarthritis that is symptomatic, requiring treatment other than debridement or microfracture.
2. Tibial eminence/spine fractures treated surgically.
3. Concomitant collateral, posterior cruciate, and/or cartilage pathology requiring surgical reconstruction and/or advanced restoration techniques (i.e., osteochondral allograft or autograft transfer, matrix-induced autologous chondrocyte implantation, particulate juvenile articular cartilage allograft transplantation).
4. Previous ACL reconstruction in the affected knee or contralateral knee.
5. Previous distal femur and/or proximal tibial/fibular physeal injury in the affected knee or contralateral knee.
6. Allograft or allograft-augmentation, or synthetic augmentation of the ACL reconstruction.
7. Biological-augmentation of the ACL reconstruction (i.e. platelet-rich-plasma, fibrin clot, reinforced bioinductive implants, etc.).
8. ACL reconstruction utilizing synthetic grafts.
9. Primary ACL repair.
10. Patient diagnosed with inflammatory arthropathy.
11. Significant medical co-morbidities (requiring daily assistance for activities of daily living).
12. Patient, parent/guardian, and/or clinical investigator believe the patient will have difficulty maintaining follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Soft-tissue hamstring; All patients in the study will undergo arthroscopic-assisted, single-bundle, complete transphyseal, anatomic primary ACL reconstruction at the discretion of the surgeon, considering the individual patient's age, physeal status, and anticipated years of growth remaining to skeletal maturity. Patients in this arm will undergo soft-tissue autograft reconstruction using hamstrings (i.e. semitendinosus and/or gracilis) grafts. Grafts will be secured on the femur and tibia according to surgeon preference, given literature demonstrating no clear superior method for graft fixation.	Procedure: Soft tissue hamstring autograft; Patients will be prescribed to receive a soft tissue hamstring autograft to for ACL reconstruction.
Active Comparator: Quadriceps tendon; Patients in this arm will undergo soft-tissue autograft reconstruction using all-soft-tissue quadriceps (i.e. full or partial thickness) grafts. Grafts will be secured on the femur and tibia according to surgeon preference, given literature demonstrating no clear superior method for graft fixation.	Procedure: Quadriceps tendon autograft; Patients will be prescribed to receive a quadriceps tendon autograft to for ACL reconstruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of ACL failure	ACL graft failure is a composite outcome defined by MRI confirmation of rupture and/or asymmetrical symptomatic laxity (i.e., positive Lachman and/or positive pivot shift).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Return to Sport	Return to sport (at any level and to pre-injury level) will be evaluated using the Tegner Activity Scale. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports, in which the response is presented as an 11-point Likert scale, where 0 indicates the lowest level of ability to perform work and sport functions, and 10 indicates competitive participation in high level sports.	2 years
Patient Reported Knee Function	Patient Knee Function will be evaluated using the Pediatric International Knee Documentation Committee Subjective Form (Pedi-IKDC). The Pedi-IKDC is a 15 question form that consists of measures of daily living and sport activity, in which the response options are presented as either 4 or 10 point Likert scales. Scores for the form range from 0 (lowest level of function) to 100 (highest level of function).	2 years
Knee Pain	Knee pain will be evaluated using a 100-point Visual Analogue Scale (VAS). The VAS has been validated in ACL patients and is one of the most commonly used pain rating scores both in research and clinical practice as it is an easy-to-use, validated, one-dimensional scale that does not require verbal or reading skills.	2 years
Health-Related Quality of Life	Health-related quality of life (HRQL) and health utility will be evaluated using the EuroQol 5 Dimensions for Youth (EQ-5D-Y-3L) questionnaire.The EQ-5D is a standardized, utility-based instrument for use as a measure of HRQL and health utility. Similar to the adult version, the EQ-5D-Y-3L comprises 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression. The EQ-5D-Y-3L has been extensively validated in international paediatric populations.	2 years
Psychological Readiness to Return-to-Sport	Psychological predictors, specifically psychological readiness to return-to-sport, will be evaluated using the Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) questionnaire, which has been shown to be reliable and responsive at the group (study) level in younger populations across all sexes. The ACL-RSI scale has 3 domains: risk appraisal, confidence, and emotions. Greater psychological preparation is indicated by higher scores.	2 years
Range of Motion	Knee range of motion (ROM) and both anterior-posterior and rotational stability will be evaluated through physical examination (i.e. Lachman and pivot shift tests, respectively). ROM will be measured in the flexion-extension (i.e. sagittal) plane using a goniometer. Anterior-posterior stability will be measured using the Lachman test, given its non-invasive nature, high sensitivity, superiority over the anterior drawer test, and by virtue of being the most reliable clinical method to assess ACL integrity. It will be performed in the supine position, with the extremity in 20-30° of knee flexion, as is commonly described. Similarly, rotational stability will be assessed using the standardized pivot shift test, performed in 30° of knee flexion.	2 years
Adverse Events	The expert Adjudication Committee will evaluate all graft failures, re-operations and other knee-related adverse events through a process of independent review and consensus, guided by decision rules detailed in the Adjudication Charter (drafted using recommendations from the literature, tested for validity and agreement among the adjudicators, and in use for the pilot study). An adverse event is defined as any symptom, sign, illness, or experience that develops or worsens in severity during the course of the trial.	2 years

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian Institutes of Health Research (CIHR); Canadian Orthopaedic Foundation; The Physicians' Services Incorporated Foundation
• Investigators: Principal Investigator: Darren de SA, MD, FRCSC, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Autograft; Quadriceps Tendon; Soft-tissue hamstring
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: SQuASH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No