Suture-tape augmentation of anterior cruciate ligament reconstruction: a randomised controlled trial

INTERVENTION: 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 CONDITION: Anterior cruciate ligament rupture; ; Anterior cruciate ligament rupture Injuries and Accidents ‐ Other injuries and accidents Musculoskeletal ‐ Other muscular and skeletal disorders Surgery ‐ Surgical techniques PRIMARY OUTCOME: Residual knee laxity: As assessed by the GNRB arthrometer, the primary outcome will be the mean difference between operative and non‐operative limbs (side‐to‐side). [2 years post operative] SECONDARY OUTCOME: Absolute return to sport rates collected via patient reported online questionnaires custom designed for this study[Assessed at 6 weeks, 3 months, 12 months and 24 months post operatively.] Complications including; pain levels, graft failure rates, contralateral ACL rupture, timing of graft failure, return to theatre, second look arthroscopy rates and findings assessed by regular review of the medical record[Assessed at 6 weeks, 3 months, 12 months and 24 months post operatively.] Knee range of motion as assessed by the associate investigators (estimated visually)[Assessed preoperatively, and at 6 weeks, 3 months and 12 months post operatively. ] Knee specific quality of life as assessed by the The international knee documentation committee subscale (IKDC)[Assessed preoperatively, and at 6 weeks, 3 months, 12 months and 2 years postoperative. ] Overall quality of life as assessed by the EQ5D‐5L subscale[Assessed preoperatively, and at 6 weeks, 3 months, 12 months and 2 years postoperative. ] Residual knee laxity: As assessed by the GNRB arthrometer, the primary outcome will be the mean difference between operative and non‐operative limbs (side‐to‐side). [Assessed preoperatively, and at 3 months and 12 months post operative. ] Return to physical acitivity as assessed by the Marx Activity Scale[Assessed preoperatively, and at 6 weeks, 3 months, 12 months and 2 years postoperative. ] Return to sport as assessed by the The Anterior Cruciate Ligament Return to Sport Index (ACL RSI)[Assessed preoperatively, and at 6 weeks, 3 months, 12 months and 2 years postoperative. ] the Knee Injury and Osteoarthritis Outcome Score Quality of Life scale (KOOS QOL)[Assessed preoperatively, and at 6 weeks, 3 months, 12 months and 2 years postoperative. ] The presence (and grade) of a positive anterior draw test as assessed by the associate investigators. This is a subjective knee examination which assesses the degree of anterior tibial translation relative to the femur at 90 degrees of knee flexion (which would usually be limited by an intact anterior cruciate ligament). Grading will be as follows; grade 1: 5 mm; grade 11: 5‐10 mm; grade Ill: more than 10 mm, A: Firm end point, B: Soft end point. [Assessed preoperatively, and at 6 weeks, 3 months and 12 months post operatively. ] The presence (and grade) of a positive Lachmans test as assessed by the associate investigators. This is a subjective knee examination which assesses the degree of anterior tibial translation relative to the femur at 30 degrees of knee flexion (which would usually be limited by an intact anterior cruciate ligament). Grading will be as follows; grade 1: 5 mm; grade 11: 5‐10 mm; grade Ill: more than 10 mm, A: Firm end point, B: Soft end point. [Assessed preoperatively, and at 6 weeks, 3 months and 12 months post operatively. ] The presence of a positive (and grade) pivot shift test as assessed by the associate investigators. This is a subjective test of anterolateral knee stability whereby the examiner aims to sublux the lateral tibial plateau in extension by applying a valgus force to the knee and internally rotating the tibia, before flexing the knee to observe a reducing motion at increasing degrees of knee flexion. This motion would usually be limited by an intact anterior cruciate ligament. Grading will be 0; no pivot I: glide, II: clunk, III: gross clunk. [Assessed preoperatively, and at 6 weeks, 3 months and 12 months post operatively. ] The presence of knee effusion on examination (patellar tap test and medial swipe test) as assessed by the associate investigators [Assessed preoperatively, and at 6 weeks, 3 months and 12 months post operatively. ] Time to return to performance as assessed by participants (time to return to previous level of sporting performance as appraised by participants) collected by patient reported online questionnaires custom designed for this study. [Assessed at 6 weeks, 3 months, 12 months and 24 months post operatively.] Time to return to sport collected by patient reported online questionnaires (number of days between operation and return to full engagement in sport e.g. games) custom designed for this study. [Assessed at 6 weeks, 3 months, 12 months and 24 months post operatively.] 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.