骨格が未熟な患者における軟部組織大腿四頭筋自家移植ACL再建とハムストリングス再建

基本情報

NCT ID: NCT03896464
ステータス: 募集中
試験のフェーズ: 該当なし
試験タイプ: 介入
目標被験者数: 352
治験依頼者名: McMaster University

概要

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.

対象疾患

ACL - Anterior Cruciate Ligament Rupture

介入

Soft tissue hamstring autograft(PROCEDURE)

Quadriceps tendon autograft(PROCEDURE)

依頼者（Sponsor）

The Physicians' Services Incorporated Foundation(OTHER)

Canadian Institutes Of Health Research (Cihr)(OTHER_GOV)

Mcmaster University(OTHER)

Canadian Orthopaedic Foundation(OTHER)

実施施設 (1)

Kobe University

Kobe, Japan(RECRUITING)