None listed
Conditions
Brief summary
This is a parallel arm, 1:1 allocated randomised controlled trial comparing anterior cruciate ligament (ACL) reconstruction with suture tape augmentation of the graft to standard ACL reconstructive technique. Whilst many ACL reconstruction patients return to sport, a significant minority suffer complications of graft rupture, particularly during the early return to sport and rehabilitative period. Inherent weakness of the graft in withstanding the loads applied during these periods has been attributed to graft failure risk, as well as residual laxity (looseness) of the knee. Recently, the use of suture-tape to run alongside the graft (or augment) has emerged to increase the strength of the new ACL, however, there is little comparative evidence available regarding this technique, particularly in its capacity to reduce residual knee laxity, or improve patient outcomes after ACLR. We aim to investigate the use of this technique by randomly allocating ACL reconstructive patient to receive it, or standard technique (the same surgery without the additional suture). We will compare the outcomes following this by testing the looseness of the knee at standard time points (3 months, 12 months and 2 years) compared with the patients other 'normal' knee. We will also compare patient reported outcomes (via patient delivered surveys), findings on examination of the knee, return to sport times and rates and complications such as the need for return to surgery, and failure of the ACL reconstruction. We will perform this study with an aim to improve our understandings about the potential benefit or harms associated with tape augmentation, with the hope that it will inform the use of this technique in future patients needing to undergo ACL reconstruction to return to sport. We hypothesise that patients whose knees are reconstructed with suture-tape augmented grafts will have a smaller difference between operative and non operative sides at two years after surgery, compared with patients who undergo standard ACL reconstruction. Secondly, we hypothesise that patients with tape augmented ACL grafts will return to sport sooner, and have improved patient reported outcome measures during the follow up period (2 years).
Interventions
This study will assess the intervention of additional suture-tape augmentation of anterior cruciate ligament (ACL) grafts during ACL reconstruction. The intervention will be delivered by by Australian AOA (Australian Orthopaedic Association) certified, fellowship trained sports knee surgeons familiar with the technique or by trainees directly supervised by the above surgeons. Patients randomized to the suture tape augmentation (SA) arm will have a single strand of Fibertape looped through the pr
This study will assess the intervention of additional suture-tape augmentation of anterior cruciate ligament (ACL) grafts during ACL reconstruction. The intervention will be delivered by by Australian AOA (Australian Orthopaedic Association) certified, fellowship trained sports knee surgeons familiar with the technique or by trainees directly supervised by the above surgeons. Patients randomized to the suture tape augmentation (SA) arm will have a single strand of Fibertape looped through the proximal Tightrope construct prior to graft implantation to serve as a suture augment. The femoral button and graft will then be shuttled through the proximal bone tunnel and docked into place. The tibial end of the graft will then be pulled through the tibial tunnel, along with the free ends of the suture tape. The suture tape will be tensioned independently of the graft according to previously described techniques. A guide pin is drilled 1.5 cm distal to the ABS tibial fixation to a depth of 20mm, and subsequently reamed to a 4.5mm diameter. Ensuring the free ends of the Fibertape are separate from the tibial sided graft sutures, a haemostat or artery forceps is then placed underneath the FiberTape limbs to ensure it is not tighter than the graft. The suture tape is then fixed with a 19mm knotless Swivelock anchor, always in full extension to avoid limiting extension of the joint. The knee is then taken through range of motion to ensure full range is present. The tibial side of the graft is then fixed with an interference screw (BioComposite; Arthrex Inc.) at 0 degrees of knee flexion in standard fashion. The knee is then cycled through range of motion to ensure full range. Closure is performed in a standardised method. It is anticipated that the incorporation of suture tape will add no more than 5 minutes to the surgical time. The surgery itself will take between 60-120 minutes depending on concomitant procedures undertaken. All participants are expected to be discharged the following day. Adherence to the intervention will be monitored by documentation by the surgeon in a study specific form at the end of each surgery.
Sponsors
Western Health - Sunshine Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be included if they are; waitlisted for ACLR with either of the associated investigators (S.T or L.B). Waitlisting is based on MRI imaging, clinical examination in keeping with a ruptured anterior cruciate ligament and the appropriate lifestyle indication for surgical reconstruction of the ligament, are able to give informed consent and to participate fully in the interventions and follow-up procedures. Adult patients aged 18 and over where ACLR technique will not be modified due to the presence of open physes. Patients with concomitant meniscal and/or osteochondral pathology can be included.
Exclusion criteria
Participants will be excluded on the basis of the following; The participant has had a previous ACL reconstruction on the ipsilateral knee, participant has had a previous ACL injury on the non operative knee, is of an developmental age where the presence of open physes would otherwise alter the surgical technique utilised, has grade 2 or 3 medial collateral ligament (MCL)/lateral collateral ligament (LCL) injury, associated posterior cruciate ligament (PCL)/ posterolateral corner (PLC) injury that requires surgical intervention, has inflammatory arthritis, is pregnant, has an articular cartilage defect requiring treatment that would alter the post-operative rehabilitation protocol and timelines, has a meniscal injury requiring treatment that would alter the post-operative rehabilitation protocol and timelines (i.e meniscal root or bucket handle tear repair), has an ACL re-rupture risk significant enough to warrant the addition of an osteotomising procedure or lateral extraarticular tenodesis.
Outcome results
None listed