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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    100
  • sponsor
    McMaster University
Updated on 11 February 2021
autograft

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.

Details
Condition ACL - Anterior Cruciate Ligament Rupture, ACL - Anterior Cruciate Ligament Rupture, ACL - Anterior Cruciate Ligament Rupture
Treatment Quadriceps tendon autograft, Soft tissue hamstring autograft
Clinical Study IdentifierNCT03896464
SponsorMcMaster University
Last Modified on11 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 10 yrs and 18 yrs?
Gender: Male or Female
Do you have ACL - Anterior Cruciate Ligament Rupture?
Do you have any of these conditions: Do you have ACL - Anterior Cruciate Ligament Rupture??
Do you have any of these conditions: Do you have ACL - Anterior Cruciate Ligament Rupture??
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
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