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

ACL - Anterior Cruciate Ligament Rupture Clinical Trial

— SQuASH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03896464
• Other study ID #: SQuASH
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: McMaster University
• Contact: Darren de SA, MD, FRCSC
• Phone: 9059232126
• Email: darren.desa[@]medportal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• ACL - Anterior Cruciate Ligament Rupture
• Rupture

Intervention

Procedure:
• Soft tissue hamstring autograft
Patients will be prescribed to receive a soft tissue hamstring autograft to for ACL reconstruction.
• Quadriceps tendon autograft
Patients will be prescribed to receive a quadriceps tendon autograft to for ACL reconstruction.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	Children's Hospital of Western Ontario	London	Ontario
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Canadian Orthopaedic Foundation, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Range of Motion	Knee range of motion and both anterior and posterior and rotational stability will be evaluated.	2 years
Secondary	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
Secondary	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
Secondary	Anterolateral Rotary Instability of the Knee	The pivot shift test will be used to detect anterolateral rotary instability of the knee	2 years