Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings

Study Overview
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Brief Summary
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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.

Official Title
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Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings (SQuASH): A Multi-Centre Randomized Controlled Trial

Conditions
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ACL - Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Procedure: Soft tissue hamstring autograft
* Procedure: Quadriceps tendon autograft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Soft-tissue hamstring<br>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<br>* Patients will be prescribed to receive a soft tissue hamstring autograft to for ACL reconstruction.<br>|
| Active Comparator: Quadriceps tendon<br>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<br>* Patients will be prescribed to receive a quadriceps tendon autograft to for ACL reconstruction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of reoperation | 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 | 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 | 
| Range of Motion | 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 | Incidence of these injuries will be confirmed through standing hip-to-ankle plain radiographs | 2 years | 
| Anterior Cruciate Ligament Integrity | 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 | The pivot shift test will be used to detect anterolateral rotary instability of the knee | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autograft, Soft-tissue hamstring, Quadriceps Tendon