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

McMaster University352 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

352

Conditions

ACL - Anterior Cruciate Ligament Rupture

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Rate of ACL failure

ACL graft failure is a composite outcome defined by MRI confirmation of rupture and/or asymmetrical symptomatic laxity (i.e., positive Lachman and/or positive pivot shift).

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 2 years

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).

Time frame: 2 years

Knee Pain

Knee pain will be evaluated using a 100-point Visual Analogue Scale (VAS). The VAS has been validated in ACL patients and is one of the most commonly used pain rating scores both in research and clinical practice as it is an easy-to-use, validated, one-dimensional scale that does not require verbal or reading skills.

Time frame: 2 years

Health-Related Quality of Life

Health-related quality of life (HRQL) and health utility will be evaluated using the EuroQol 5 Dimensions for Youth (EQ-5D-Y-3L) questionnaire.The EQ-5D is a standardized, utility-based instrument for use as a measure of HRQL and health utility. Similar to the adult version, the EQ-5D-Y-3L comprises 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression. The EQ-5D-Y-3L has been extensively validated in international paediatric populations.

Time frame: 2 years

Psychological Readiness to Return-to-Sport

Psychological predictors, specifically psychological readiness to return-to-sport, will be evaluated using the Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) questionnaire, which has been shown to be reliable and responsive at the group (study) level in younger populations across all sexes. The ACL-RSI scale has 3 domains: risk appraisal, confidence, and emotions. Greater psychological preparation is indicated by higher scores.

Time frame: 2 years

Range of Motion

Knee range of motion (ROM) and both anterior-posterior and rotational stability will be evaluated through physical examination (i.e. Lachman and pivot shift tests, respectively). ROM will be measured in the flexion-extension (i.e. sagittal) plane using a goniometer. Anterior-posterior stability will be measured using the Lachman test, given its non-invasive nature, high sensitivity, superiority over the anterior drawer test, and by virtue of being the most reliable clinical method to assess ACL integrity. It will be performed in the supine position, with the extremity in 20-30° of knee flexion, as is commonly described. Similarly, rotational stability will be assessed using the standardized pivot shift test, performed in 30° of knee flexion.

Time frame: 2 years

Adverse Events

The expert Adjudication Committee will evaluate all graft failures, re-operations and other knee-related adverse events through a process of independent review and consensus, guided by decision rules detailed in the Adjudication Charter (drafted using recommendations from the literature, tested for validity and agreement among the adjudicators, and in use for the pilot study). An adverse event is defined as any symptom, sign, illness, or experience that develops or worsens in severity during the course of the trial.

Time frame: 2 years

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts