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

ConditionACL - Anterior Cruciate Ligament Rupture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorMcMaster University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients 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.

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).

Disqualifiers

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.

Tibial eminence/spine fractures treated surgically.

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).

Previous ACL reconstruction in the affected knee or contralateral knee.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Soft tissue hamstring autograft

    Procedure/Surgery

    Patients will be prescribed to receive a soft tissue hamstring autograft to for ACL reconstruction.

  • Quadriceps tendon autograft

    Procedure/Surgery

    Patients will be prescribed to receive a quadriceps tendon autograft to for ACL reconstruction.

Treatment groups

352 Participants
are divided into 2 treatment groups
Group A: Soft-tissue hamstringActive comparator 1 intervention
Group B: Quadriceps tendonActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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McMaster University

Lead sponsor

Canadian Orthopaedic Foundation

Collaborator

The Physicians' Services Incorporated Foundation

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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