None listed
Conditions
Brief summary
This is a prospective randomized controlled trial (RCT) comparing the outcome of patients undergoing primary anterior cruciate ligament reconstruction (ACLR) with either a hamstring tendon (HT) or a quadriceps tendon (QT) autograft. Patient outcomes will be collected and compared between the two surgical cohorts over a 24 month post-operative period, and will include a range of subjective and functional outcomes, knee movement and laxity measures, patient satisfaction, and kneeling tolerance.
Interventions
This is a prospective randomized controlled trial (RCT) comparing the outcome of patients undergoing primary anterior cruciate ligament reconstruction (ACLR) with either a hamstring tendon (HT) or a quadriceps tendon (QT) autograft. Patient outcomes will be collected and compared between the two surgical cohorts over a 24 month post-operative period, and will include a range of subjective and functional outcomes, knee movement and laxity measures, patient satisfaction, and kneeling tolerance. This trial has been designed as a randomised, controlled, multicentre trial with two parallel groups. Block randomisation will be performed with a 1:1 allocation. All patients who are undergoing primary ACLR with the primary surgeon will be invited to participate in this trial. Participants will be invited to be part of the study after consultation with their surgeon, having confirmed ACL rupture by clinical examination and magnetic resonance imaging (MRI), and being scheduled for surgery. Initial contact and recruitment will be conducted by a member of the research team. Patients will undergo ACLR, under general anaesthetic. Surgery will take between 45-90 minutes. Patients will have a standardised anaesthetic regime, consisting of a single-shot adductor canal regional block using 0.375% ropivacaine plus 8mg dexamethasone, placed with ultrasound guidance once the patient is under general anaesthetic. If randomised to the HT graft, HT graft harvest will be obtained via a transverse incision over the pes anserinus. Semitendinosus will be harvested using a closed tendon harvester, quadrupled and prepared. The investigator's preference is to use the Arthrex graftlink system, enabling single HT harvest for the majority of cases. In the case of a small diameter graft, gracilis will be harvested and used in combination. If randomised to the QT graft, QT harvest will be obtained via a longitudinal incision over the distal portion of the quadriceps tendon and proximal pole of patella. A soft-tissue graft will be obtained using a 9, 10 or 11mm graft harvester depending on the size of the patient. Approximately 70mm of graft will be harvested, and then prepared as per guidelines for use with the Arthrex graftlink system, enabling the same graft fixation techniques to be employed for both graft types. Knee arthroscopy will then be performed, with treatment of any chondral or meniscus injury as dictated by the intra-operative findings. Femoral and tibial tunnels will be prepared to allow for passage of the graft in an anterograde manner, using adjustable loop fixation for both the femoral and tibial fixation. Graft tensioning will be performed in full knee extension in line with the manufacturers recommendations, with cycling of the graft prior to final fixation. The wounds will be closed in layers, haemostasis ensured and absorbable subcuticular wound closure employed. Dressings will be applied, followed by wool and crepe bandages. A straight splint will be applied whilst the patient is under general anaesthetic, which is used for pain relief in the early post-operative phase only.
Sponsors
Study design
Eligibility
Inclusion criteria
• The individual is between the ages of 16 and 50 years. • The individual clinically qualifies for ACLR surgery based on clinical examination and MRI. • The individual has sustained the ACL tear within the last 12 months. • The individual is not currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol/substance abuse.
Exclusion criteria
• The individual is unable or unwilling to sign the Patient Informed Consent, specific to this study, and approved by the Institutional Ethics Review Board. • The individual is unable or unwilling to follow the designated rehabilitation protocol. • The individual is classified as morbidly obese (>40 BMI). • The individual is skeletally immature. • The ACLR is combined with another ligament reconstruction or repair in the knee (multi- ligament knee reconstruction). • Revision ACLR procedures.