RecruitingACTRN12618001382268

Does preoperative anterior cruciate ligament rehabilitation produce superior outcomes before and after reconstructive surgery compared to current care

Preoperative anterior cruciate ligament rehabilitation compared to current care


Sponsor

Auckland University of Technology

Enrollment

120 participants

Start Date

Jan 7, 2019

Study Type

Interventional

Conditions

Summary

This is a prospective randomised controlled trial (RCT) investigating the effectiveness of preoperative rehabilitation (n=60) on patients with a torn anterior cruciate ligament (ACL) before and after reconstructive surgery compared to current care (n=60). The preoperative rehabilitation is aimed at improving quadriceps strength, which is negatively affected by injury and surgery. Quadriceps strength will be measured using previously validated Biodex dynamometry at baseline, after 6-weeks of preoperative rehabilitation and 12 weeks after ACL surgical reconstruction. In addition, knee function will be assessed with a variety of previously used measures including singled legged hop tests, KOOS, Tegner, and Marx self-reporting scales. The hypotheses: six-weeks of KneeCare ACL preoperative rehabilitation will improve preoperative and postoperative quadriceps strength following ACL reconstruction when compared to not receiving ACL KneeCare preoperative rehabilitation.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

Tearing the anterior cruciate ligament (ACL) — one of the main stabilising ligaments in the knee — is a common and often devastating sports injury. Surgery to reconstruct the ACL is frequently recommended, but outcomes vary significantly between patients. One factor that affects post-operative recovery is the strength of the quadriceps muscles at the time of surgery — and many patients have significantly weakened quads by the time they go into theatre. This study is testing whether six weeks of targeted pre-operative rehabilitation (called 'prehab') improves quadriceps strength before surgery, and whether those strength gains also translate into better recovery after reconstruction. Participants will be randomly assigned to either complete the prehab program before their surgery or to follow current standard care (no prehab). You may be eligible if you are aged 18 to 50, have been diagnosed with a primary ACL tear by a surgeon and MRI scan, are awaiting reconstructive surgery, and have an ACC injury claim registered in New Zealand. You would not be eligible if you have had a serious injury to the other knee or cannot participate in an exercise program.

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Interventions

Patients who satisfy eligibility criteria of a primary unilateral anterior cruciate ligament (ACL) rupture awaiting surgery are referred by their Surgeon to consider participation in preoperative reha

Patients who satisfy eligibility criteria of a primary unilateral anterior cruciate ligament (ACL) rupture awaiting surgery are referred by their Surgeon to consider participation in preoperative rehabilitation. After undergoing baseline testing consisting of validated isokinetic strength testing of the quadriceps, hop tests (6m and maximal distance), and self-reported scales (KOOS, Tegner, Marx) consented participants are randomised into either the intervention (Group 1) or current care (Group 2) cohort. The intervention cohort complete a 6-week supervised preoperative rehabilitation protocol, and Group 2 continue with their usual care and preparation for 6 weeks while awaiting surgical reconstruction. The intervention methodology consists of progressive overloading exercise focused on quadriceps strength, and is delivered by a specifically qualified physiotherapist twice per week. After completing the respective 6 week preoperative phases participants are re-tested, and then undergo ACL reconstruction. All participants can receive post-operative rehabilitation as guided by their Surgeon and return for final assessment 12 weeks post-surgically. Post-operative rehabilitation is unrestricted over the 12-week reassessment timeframe as evidence suggests that irrespective of the type of post-operative rehabilitation protocol the critical success factor up to 2 years post surgically is preoperative rehabilitation aimed at optimising quadriceps strength. Therefore, the study design is confined to examining the effectiveness of preoperative rehabilitation, and no constraints or control over post-operative rehabilitation has been given. After the final assessment, a small number of selected participants from each cohort will be interviewed using a written series of questions related to the experience of undergoing rehabilitation for their ACL injury.


Locations(1)

Auckland, New Zealand

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ACTRN12618001382268