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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001382268
Enrollment
80
Registered
2018-08-16
Start date
2019-01-07
Completion date
2019-10-28
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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

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.

Sponsors

Auckland University of Technology
Lead SponsorUniversity

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 50 Years
Healthy volunteers
No

Inclusion criteria

• Diagnosed with a primary unilateral ACL by Surgeon and MRI • Awaiting reconstructive surgery • Referred for physiotherapy • 18-50 years of age • Injury claim lodged and registered with the ACC

Exclusion criteria

• History of significant contralateral knee injury, fracture, full thickness chondral injury, symptomatic meniscal injury. • Unable to undertake an exercise programme

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026