ACL - Anterior Cruciate Ligament RuptureSQuASHNCT03896464
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
A study testing Soft tissue hamstring autograft and Quadriceps tendon autograft in people with ACL - Anterior Cruciate Ligament Rupture, run by McMaster University at 6 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Rupture
- What is being tested?
- Soft tissue hamstring autograft and Quadriceps tendon autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Jan 2020to 1 Jan 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 10-18 years.
- History, physical exam, and magnetic resonance imaging (MRI) or arthroscopic image confirmation of ACL insufficiency.
- Suitable for anatomic, single-bundle arthroscopic-assisted ACL reconstruction.
- 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).
- Patient involved in sport (competitive and/or recreational level) prior to injury.
- Patient and parent/guardian speak, read, and understand the language of the clinical site.
- Patient and parent/guardian provide informed consent and/or assent.
Who cannot join
- 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.
- Tibial eminence/spine fractures treated surgically.
- 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).
- Previous ACL reconstruction in the affected knee or contralateral knee.
- Previous distal femur and/or proximal tibial/fibular physeal injury in the affected knee or contralateral knee.
- Allograft or allograft-augmentation, or synthetic augmentation of the ACL reconstruction.
Show all 12Show fewer
- Biological-augmentation of the ACL reconstruction (i.e. platelet-rich-plasma, fibrin clot, reinforced bioinductive implants, etc.).
- ACL reconstruction utilizing synthetic grafts.
- Primary ACL repair.
- Patient diagnosed with inflammatory arthropathy.
- Significant medical co-morbidities (requiring daily assistance for activities of daily living).
- Patient, parent/guardian, and/or clinical investigator believe the patient will have difficulty maintaining follow-up.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Canada5 sites, 5 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8N3Z5
Darren de SA, MSc, darren.desa@medportal.ca
Nicole Simunovic, MSc, (289) 237-3224, simunon@mcmaster.ca
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Nathalie Jourdain
Marie-Lyne Nault, MD, FRCSC
- Recruiting
Shriners Hospitals for Children - Canada
Montreal, Quebec, H4A 0A9
Nicolas Herrera, MSc
Justin Drager, MD, FRCSC
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Sasha Carsen, MD
Sasha Carsen, MD
- Recruiting
Women's College Hospital/Research Institute
Toronto, Ontario, M5S 1B2
Ananya Pathak, MSc
Jihad Abouali, MD, FRCSC
Japan1 site, 1 recruiting
- Recruiting
Kobe University
Kobe
Kanto Nagai, MD, PhD
Kanto Nagai, MD, PhD
About this study
Official title: 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.
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Being tested
- Soft tissue hamstring autograft, Quadriceps tendon autograft
- Keywords
- Autograft, Soft-tissue hamstring, Quadriceps Tendon
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue hamstring autograftProcedure or surgery
Patients will be prescribed to receive a soft tissue hamstring autograft to for ACL reconstruction.
Quadriceps tendon autograftProcedure or surgery
Patients will be prescribed to receive a quadriceps tendon autograft to for ACL reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Soft-tissue hamstring | Active comparator | 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. Receives: Procedure: Soft tissue hamstring autograft |
| Quadriceps tendon | Active comparator | 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. Receives: Procedure: Quadriceps tendon autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Jan 2020
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACL - Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Orthopaedic Foundation, The Physicians' Services Incorporated Foundation, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Darren de SA, MD, FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896464
- Sponsor's protocol ID
- SQuASH
- Acronym
- SQuASH
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2019
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ayeni OR; SQuASH Investigators. Soft-tissue quadriceps tendon autograft during primary anterior cruciate ligament reconstruction in Skeletally-immature patients vs. Hamstrings: A protocol for a multi-centre randomized controlled trial. J Orthop Surg Res. 2025 Dec 1;21(1):6. doi: 10.1186/s13018-025-06534-0.
PubMed 41327264