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

Primary Purpose

ACL - Anterior Cruciate Ligament Rupture

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Soft tissue hamstring autograft
Quadriceps tendon autograft
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL - Anterior Cruciate Ligament Rupture focused on measuring Autograft, Soft-tissue hamstring, Quadriceps Tendon

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McMaster UniversityRecruiting
  • Children's Hospital of Western Ontario
  • Children's Hospital of Eastern Ontario

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Soft-tissue hamstring

Quadriceps tendon

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
Range of Motion
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
Incidence of these injuries will be confirmed through standing hip-to-ankle plain radiographs
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.
Anterolateral Rotary Instability of the Knee
The pivot shift test will be used to detect anterolateral rotary instability of the knee

Full Information

First Posted
March 27, 2019
Last Updated
May 30, 2023
Sponsor
McMaster University
Collaborators
Canadian Orthopaedic Foundation, The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03896464
Brief Title
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
Acronym
SQuASH
Official Title
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings (SQuASH): A Multi-Centre Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Canadian Orthopaedic Foundation, The Physicians' Services Incorporated Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL - Anterior Cruciate Ligament Rupture
Keywords
Autograft, Soft-tissue hamstring, Quadriceps Tendon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Soft-tissue hamstring
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Quadriceps tendon
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Soft tissue hamstring autograft
Intervention Description
Patients will be prescribed to receive a soft tissue hamstring autograft to for ACL reconstruction.
Intervention Type
Procedure
Intervention Name(s)
Quadriceps tendon autograft
Intervention Description
Patients will be prescribed to receive a quadriceps tendon autograft to for ACL reconstruction.
Primary Outcome Measure Information:
Title
Rate of reoperation
Description
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).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Rate of Return to Sport
Description
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.
Time Frame
2 years
Title
Patient Reported Knee Function
Description
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).
Time Frame
2 years
Title
Range of Motion
Description
Knee range of motion and both anterior and posterior and rotational stability will be evaluated.
Time Frame
2 years
Title
Incidence of distal femoral and/or proximal tibial/fibular physeal injury
Description
Incidence of these injuries will be confirmed through standing hip-to-ankle plain radiographs
Time Frame
2 years
Title
Anterior Cruciate Ligament Integrity
Description
The Lachman test will be used to evaluate single and sagittal plane instability to determine integrity of the anterior cruciate ligament.
Time Frame
2 years
Title
Anterolateral Rotary Instability of the Knee
Description
The pivot shift test will be used to detect anterolateral rotary instability of the knee
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darren de SA, MD, FRCSC
Phone
9059232126
Email
darren.desa@medportal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Simunovic, MSc
Phone
(289) 237-3224
Email
simunon@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darren de SA, MD, FRCSC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darren de SA, MSc
Email
darren.desa@medportal.ca
First Name & Middle Initial & Last Name & Degree
Nicole Simunovic, MSc
Phone
(289) 237-3224
Email
simunon@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Darren de SA, MD
First Name & Middle Initial & Last Name & Degree
Olufemi R Ayeni, MD, PhD
First Name & Middle Initial & Last Name & Degree
Devin C Peterson, MD
Facility Name
Children's Hospital of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Bartley, MD
First Name & Middle Initial & Last Name & Degree
Debra Bartley, MD
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasha Carsen, MD
First Name & Middle Initial & Last Name & Degree
Sasha Carsen, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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