STABILITY 2: A protocol for a randomised trial in orthopaedic surgery to determine whether anterior cruciate ligament (ACL) reconstruction using a patellar or quadriceps tendon autograft with or without lateral extra-articular tenodesis is more effective at reducing the incidence of recurrent instability in young, active athletes
Abstract
Introduction: Anterior cruciate ligament reconstruction (ACLR) is complicated by high failure rates in young, active individuals, which is associated with worse outcomes and higher rates of osteoarthritis (OA). Failure of ACLR limits activity, reduces quality of life and substantially increases socio-economic costs. Thus, strategies to reduce ACLR failure are imperative. In the STABILITY 1 trial, we showed that adding a lateral extra-articular tenodesis (LET) to ACLR with a hamstring tendon (HT) graft provided greater stability than HT alone (Relative Risk Reduction (RRR)=0.38; 95% CI 0.21 to 0.52; p<0001). Recent meta-analyses suggest patellar tendon (bone patellar tendon bone (BPTB)) grafts provide better stability than HT although with greater donor site morbidity. Recently, the quadriceps tendon (QT) graft has become popular, claiming similar stability to BPTB without donor site morbidity. However, no high-quality studies have shown it to be better and no study has determined if the reduced rate of ACLR failure seen with the addition of a LET to a HT graft is still present when using stronger, stiffer BPTB or QT grafts. Therefore, this study will evaluate whether in patients at high risk of rerupture, graft type (QT, BPTB, HT) with or without a LET offers a greater reduction in rate of clinical failure, better performance-based function and patient-reported symptoms, function and quality of life or higher rates of return to sport 2 years after ACLR. And does graft…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,292 participants or records.
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