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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
Sponsor:
Collaborators:
Canadian Orthopaedic Foundation
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
McMaster University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
ACL - Anterior Cruciate Ligament Rupture Procedure: Soft tissue hamstring autograft Procedure: Quadriceps tendon autograft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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. 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).

  3. Range of Motion [ Time Frame: 2 years ]
    Knee range of motion and both anterior and posterior and rotational stability will be evaluated.

  4. 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

  5. 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.

  6. 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



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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females aged 10-18 years.
  2. History, physical exam, and magnetic resonance imaging (MRI) or arthroscopic image confirmation of ACL insufficiency.
  3. Suitable for anatomic, single-bundle arthroscopic-assisted ACL reconstruction.
  4. Complete or partial transphyseal ACL femoral and tibial tunnel drilling/reconstruction techniques.
  5. Patient involved in sport (competitive and/or recreational level) prior to injury.
  6. Patient and parent/guardian speak, read, and understand the language of the clinical site.
  7. Patient and parent/guardian provide informed consent.

Exclusion Criteria:

  1. Evidence (i.e. radiographic and/or arthroscopic) of International Cartilage Repair Society (ICRS) Cartilage Lesion Classification System Grade 2 and higher osteoarthritis.
  2. Tibial eminemence/spine fractures.
  3. Concomitant collateral, posterior cruciate, and/or cartilage pathology.
  4. Previous knee surgery in the affected or contra-lateral knee.
  5. Previous distal femur and/or proximal tibial/fibular physeal injury in the affected or contra-lateral knee.
  6. Allograft or allograft-augmentation of the ACL reconstruction.
  7. ACL reconstruction utilizing synthetic grafts.
  8. Primary ACL repair.
  9. 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.
  10. Significant medical co-morbidities (requiring daily assistance for activities of daily living).
  11. Patient, parent/guardian, and/or clinical investigator believe the patient will have difficulty maintaining follow-up.

Information from the National Library of Medicine

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


Contacts
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Contact: Darren de SA, MD, FRCSC 9059232126 darren.desa@medportal.ca
Contact: Nicole Simunovic, MSc (289) 237-3224 simunon@mcmaster.ca

Locations
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Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8N3Z5
Contact: Darren de SA, MSc       darren.desa@medportal.ca   
Contact: Nicole Simunovic, MSc    (289) 237-3224    simunon@mcmaster.ca   
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         
Sponsors and Collaborators
McMaster University
Canadian Orthopaedic Foundation
The Physicians' Services Incorporated Foundation
Investigators
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Principal Investigator: Darren de SA, MD, FRCSC McMaster University

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03896464    
Other Study ID Numbers: SQuASH
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McMaster University:
Autograft
Soft-tissue hamstring
Quadriceps Tendon
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries