- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03896464
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings (SQuASH)
March 11, 2024 updated by: McMaster University
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 trial aims to demonstrate feasibility of a global RCT that will evaluate the efficacy of soft-tissue quadriceps versus hamstring autograft tendons on re-operation, return to sport, and knee function among paediatric patients undergoing primary ACL reconstruction.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
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
-
Principal Investigator:
- Darren De Sa, MD
-
Sub-Investigator:
- Olufemi R Ayeni, MD, PhD
-
Sub-Investigator:
- Devin C Peterson, MD
-
London, Ontario, Canada, N6A 5W9
- Not yet recruiting
- Children's Hospital of Western Ontario
-
Contact:
- Debra Bartley, MD
-
Principal Investigator:
- Debra Bartley, MD
-
Ottawa, Ontario, Canada, K1H 8L1
- Not yet recruiting
- Children's Hospital of Eastern Ontario
-
Principal Investigator:
- Sasha Carsen, MD
-
Contact:
- Sasha Carsen, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Males and females 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.
- Complete or partial transphyseal ACL femoral and tibial tunnel drilling/reconstruction techniques.
- 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.
Exclusion Criteria:
- Evidence (i.e. radiographic and/or arthroscopic) of International Cartilage Repair Society (ICRS) Cartilage Lesion Classification System Grade 2 and higher osteoarthritis.
- Tibial eminemence/spine fractures.
- Concomitant collateral, posterior cruciate, and/or cartilage pathology.
- Previous knee surgery in the affected or contra-lateral knee.
- Previous distal femur and/or proximal tibial/fibular physeal injury in the affected or contra-lateral knee.
- Allograft or allograft-augmentation of the ACL reconstruction.
- ACL reconstruction utilizing synthetic grafts.
- Primary ACL repair.
- Generalized ligamentous laxity and/or hypermobility (i.e. Beighton Criteria ≥ 4/9), given statistically significant higher failure rates (24% vs. 7.7%) and inferior subjective outcomes in this population.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
|
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.
|
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 reoperation
Time Frame: 2 years
|
Re-operation is defined as a composite of: failure (defined by one or more of: revision ACL surgery, MRI confirmation of re-rupture, Lachman 2+ and/or instrumented laxity measurement greater than 5 mm side-to-side difference), and non-failure indications (such as: meniscal tears requiring repair or menisectomy; osteochondral defects; symptomatic loose bodies; arthrofibrosis requiring manipulation under anesthesia and/or arthroscopic/open lysis of adhesions; removal of hardware; deep infection; and/or arthroscopic/open lavage without infection).
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Return to Sport
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
|
Range of Motion
Time Frame: 2 years
|
Knee range of motion and both anterior and posterior and rotational stability will be evaluated.
|
2 years
|
Incidence of distal femoral and/or proximal tibial/fibular physeal injury
Time Frame: 2 years
|
Incidence of these injuries will be confirmed through standing hip-to-ankle plain radiographs
|
2 years
|
Anterior Cruciate Ligament Integrity
Time Frame: 2 years
|
The Lachman test will be used to evaluate single and sagittal plane instability to determine integrity of the anterior cruciate ligament.
|
2 years
|
Anterolateral Rotary Instability of the Knee
Time Frame: 2 years
|
The pivot shift test will be used to detect anterolateral rotary instability of the knee
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Darren de SA, MD, FRCSC, McMaster University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
January 1, 2026
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 13, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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