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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.

Must not have

Previous knee surgery in the affected or contra-lateral knee.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my knee or the opposite knee before.

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I am very flexible or have loose joints, scoring 4 or more on the Beighton scale.

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I had ACL surgery with a man-made graft.

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I have issues with my knee's ligaments or cartilage.

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My knee damage is confirmed by tests to be Grade 2 or higher.

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I need daily help for personal care due to other health issues.

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I have had surgery to repair my ACL.

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My ACL surgery involved using donor tissue or a mix of my own and donor tissue.

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I have a fracture in the front part of my shinbone.

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I have had a previous injury to the growth plate in my knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of reoperation

Secondary study objectives

Anterior Cruciate Ligament Integrity

Anterolateral Rotary Instability of the Knee

Incidence of distal femoral and/or proximal tibial/fibular physeal injury

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 13Eligibility criteria met