Semitendinosus vs quadriceps tendon autograft in anterior cruciate ligament reconstruction (SEQUAR): protocol for a prospective randomized controlled trial
摘要
Anterior cruciate ligament (ACL) rupture is a devastating injury for most individuals, especially in athletes with the desire to go back to pivoting sports. In ACL reconstruction (ACL-R), multiple autograft options are available, each with distinct advantages and limitations. The quadriceps tendon (QT) autograft has gained increasing attention due to its favorable biomechanical properties and lower donor site morbidity, yet studies comparing only athletic populations remains limited. This study protocol describes a randomized controlled trial (RCT) aiming to compare QT autograft with bone-block (QT-B) with semitendinosus tendon (ST) autograft in athletes undergoing primary ACL-R.
MethodsThis is a single center RCT. Two Hundred ACL-R patients aged 16–40 years with a Tegner Activity Scale (TAS) of ≥ 7 prior to the ACL injury will be randomized to receive either a ST graft or a QT-B graft at the time of ACL-R. All participants will receive standard postoperative care and rehabilitation, followed by comprehensive follow-up. The primary outcome was the side-to-side (STS) difference in anterior tibial translation (ATT) at 6 months. Secondary outcomes include patient-reported outcome measures (PROMs), isokinetic strength testing, imaging-based graft evaluation, surgical and clinical events, and 10-year radiographic evidence of joint degeneration. Detailed definitions and timepoints are provided in the full manuscript (Table
This protocol is the first RCT comparing the ST autograft to the QT-B autograft exclusively in athletes with TAS ≥ 7 undergoing ACL-R. In addition, this trial has the ambition of including 200 patients, thereby making it the largest trial to compare these two grafts to date. The successful completion of the trial has the potential to change current practice and contribute to the existing knowledge regarding graft choice in athletes undergoing ACL-R.
Trial registrationThe trial is registered at ClinicalTrials.gov: NCT04295148.
Registered date: 4 Mar 2020 (retrospectively registered).