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Procedure

Quadriceps vs. Hamstring Autograft for ACL Rupture (SQuASH Trial)

N/A
Recruiting
Led By Darren de SA, MD, FRCSC
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Complete or partial transphyseal ACL femoral and tibial tunnel drilling/reconstruction techniques.
Males and females aged 10-18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

SQuASH Trial Summary

This trial aims to compare 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.

Who is the study for?
This trial is for boys and girls aged 10-18 who have had an ACL injury, speak the clinic's language, and can give informed consent. They must have been active in sports before their injury and be suitable for a specific type of knee surgery. Kids with very flexible joints, significant other health issues, or previous knee surgeries aren't eligible.Check my eligibility
What is being tested?
The study compares two types of tendon grafts used in knee surgery to repair the ACL in kids: one from the hamstring (the current standard) and one from the quadriceps (a newer option). The goal is to see which graft leads to better surgery outcomes like fewer re-operations and improved knee function.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include pain at the graft site, infection risk post-surgery, reduced range of motion or strength in the affected leg, complications related to anesthesia during surgery.

SQuASH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had ACL reconstruction with specific drilling techniques.
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I am between 10 and 18 years old.
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My ACL injury is confirmed by an MRI or arthroscopy.

SQuASH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of reoperation
Secondary outcome measures
Anterior Cruciate Ligament Integrity
Anterolateral Rotary Instability of the Knee
Incidence of distal femoral and/or proximal tibial/fibular physeal injury
+3 more

SQuASH Trial Design

2Treatment groups
Active Control
Group I: Soft-tissue hamstringActive Control1 Intervention
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.
Group II: Quadriceps tendonActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
881 Previous Clinical Trials
2,597,786 Total Patients Enrolled
Canadian Orthopaedic FoundationOTHER
13 Previous Clinical Trials
1,496 Total Patients Enrolled
The Physicians' Services Incorporated FoundationOTHER
162 Previous Clinical Trials
26,655 Total Patients Enrolled

Media Library

Quadriceps tendon autograft (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03896464 — N/A
Anterior Cruciate Ligament Rupture Research Study Groups: Soft-tissue hamstring, Quadriceps tendon
Anterior Cruciate Ligament Rupture Clinical Trial 2023: Quadriceps tendon autograft Highlights & Side Effects. Trial Name: NCT03896464 — N/A
Quadriceps tendon autograft (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03896464 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for individuals to partake in this trial?

"According to the clinicaltrials.gov website, this research venture is currently seeking volunteers; it was first published on January 1st 2020 and was most recently modified on April 4th 2022."

Answered by AI

Am I eligible to join this clinical exploration?

"The researchers seek 100 patients aged between 10 and 18 years old, who have anterior cruciate ligament. Other eligibility criteria include gender, the capability of participating in sports prior to injury, suitability for single-bundle arthroscopic assisted ACL reconstruction (including transphyseal femoral & tibial tunnel drilling/reconstruction techniques), as well as language proficiency amongst both patient and parent or guardian."

Answered by AI

What is the approximate number of participants in this experiment?

"Affirmative. The clinicaltrials.gov site shows that this trial is actively recruiting, having been first published on the 1st of January 2020 and recently updated on the 4th of April 2022. A hundred patients are sought across three different sites."

Answered by AI

Is senior participation permissible in this research trial?

"This clinical trial seeks participants who are between the age of 10 and 18 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
2020. "Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03896464.
~28 spots leftby Jan 2026
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