Clinical trial NCT03896464: Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
Official title: Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings (SQuASH): A Multi-Centre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ACL - Anterior Cruciate Ligament Rupture
Keywords: Autograft
Soft-tissue hamstring
Quadriceps Tendon
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Orthopaedic Foundation
name: The Physicians' Services Incorporated Foundation
name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-04-01
Enrollment: 352
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 is a parallel, international, multi-centre, blinded randomized controlled trial of 352 skeletally-immature (at the time of injury) patients (ages 10-18 years, inclusive) undergoing primary ACL reconstruction to compare the effect of autograft tendon choice (i.e. hamstring versus soft-tissue quadriceps) on the rates of ACL graft failure, return-to-sport, knee function, pain, health-related quality of life and health utility, psychological factors, range of motion and stability, and any other adverse events at 24 months.


Eligibility criteria: Inclusion Criteria

1. Patients 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. X-ray or MRI evidence of skeletal immaturity (i.e., open physes) based on imaging that is closest to the time of injury (and correlated with standard bone age left hand posteroanterior (PA) radiographs).
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 and/or assent.

Exclusion Criteria

1. Evidence (i.e. radiographic and/or arthroscopic) of International Cartilage Repair Society (ICRS) Cartilage Lesion Classification System Grade 2 (i.e., lesions extending down to 50% of the cartilage depth) and higher osteoarthritis that is symptomatic, requiring treatment other than debridement or microfracture.
2. Tibial eminence/spine fractures treated surgically.
3. Concomitant collateral, posterior cruciate, and/or cartilage pathology requiring surgical reconstruction and/or advanced restoration techniques (i.e., osteochondral allograft or autograft transfer, matrix-induced autologous chondrocyte implantation, particulate juvenile articular cartilage allograft transplantation).
4. Previous ACL reconstruction in the affected knee or contralateral knee.
5. Previous distal femur and/or proximal tibial/fibular physeal injury in the affected knee or contralateral knee.
6. Allograft or allograft-augmentation, or synthetic augmentation of the ACL reconstruction.
7. Biological-augmentation of the ACL reconstruction (i.e. platelet-rich-plasma, fibrin clot, reinforced bioinductive implants, etc.).
8. ACL reconstruction utilizing synthetic grafts.
9. Primary ACL repair.
10. Patient diagnosed with inflammatory arthropathy.
11. Significant medical co-morbidities (requiring daily assistance for activities of daily living).
12. Patient, parent/guardian, and/or clinical investigator believe the patient will have difficulty maintaining follow-up.

Primary outcomes:
measure: Rate of ACL failure
timeFrame: 2 years
Secondary outcomes:
measure: Rate of Return to Sport
timeFrame: 2 years
measure: Patient Reported Knee Function
timeFrame: 2 years
measure: Knee Pain
timeFrame: 2 years
measure: Health-Related Quality of Life
timeFrame: 2 years
measure: Psychological Readiness to Return-to-Sport
timeFrame: 2 years
measure: Range of Motion
timeFrame: 2 years
measure: Adverse Events
timeFrame: 2 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital/Research Institute
state: Ontario
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Montréal
country: Canada
facility: Shriners Hospitals for Children - Canada
state: Quebec
city: Kobe
country: Japan
facility: Kobe University
Study officials:
affiliation: McMaster University
name: Darren de SA, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: