Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings (SQuASH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03896464|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|ACL - Anterior Cruciate Ligament Rupture||Procedure: Soft tissue hamstring autograft Procedure: Quadriceps tendon autograft||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Autograft donation incisions will be covered with adhesive bandages for clinical outcome assessment by the attending physician. The assessor will perform a physical assessment of the patient's knees, including range of motion and laxity.|
|Official Title:||Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings (SQuASH): A Multi-Centre Randomized Controlled Trial|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2024|
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.
Procedure: Soft tissue hamstring autograft
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.
Procedure: Quadriceps tendon autograft
Patients will be prescribed to receive a quadriceps tendon autograft to for ACL reconstruction.
- 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).
- 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.
- 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).
- Range of Motion [ Time Frame: 2 years ]Knee range of motion and both anterior and posterior and rotational stability will be evaluated.
- 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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896464
|Contact: Darren de SA, MD, FRCSCfirstname.lastname@example.org|
|Contact: Nicole Simunovic, MSc||(289) email@example.com|
|Hamilton, Ontario, Canada, L8N3Z5|
|Contact: Darren de SA, MSc firstname.lastname@example.org|
|Contact: Nicole Simunovic, MSc (289) 237-3224 email@example.com|
|Principal Investigator: Darren de SA, MD|
|Sub-Investigator: Olufemi R Ayeni, MD, PhD|
|Sub-Investigator: Devin C Peterson, MD|
|Children's Hospital of Western Ontario||Not yet recruiting|
|London, Ontario, Canada, N6A 5W9|
|Contact: Debra Bartley, MD|
|Principal Investigator: Debra Bartley, MD|
|Children's Hospital of Eastern Ontario||Not yet recruiting|
|Ottawa, Ontario, Canada, K1H 8L1|
|Contact: Sasha Carsen, MD|
|Principal Investigator: Sasha Carsen, MD|
|Principal Investigator:||Darren de SA, MD, FRCSC||McMaster University|