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

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 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.

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.