A Randomised Control Trial of Rehabilitation With or Without a Knee Orthosis Following Meniscal Repair
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Change from baseline Biodex isokinetic quadriceps strength at 6 months
Overview
Brief Summary
RCT to determine if a less restrictive postoperative rehabilitation protocol following meniscal repair results in a faster return to normal knee function without compromising rates of healing.
Detailed Description
The purpose of the study is to compare rehabilitation after meniscal repair with or without the use of a knee orthosis. There is conflicting evidence regarding optimal postoperative rehabilitation following meniscal repair with ACLR. Many surgeons advocate the use of a knee orthosis which restricts flexion during the first 4-6 weeks following surgery. Some also avoid weight baring and crouching for various periods of time. This is due to the perceived risk that the healing meniscus is exposed to unnecessary strain, potentially compromising healing. There is however evidence that fewer postoperative restriction in the setting of meniscal repair in conjunction with ACLR does not compromise meniscal healing. There is also evidence that accelerated rehabilitation following isolated meniscal repair does not increase the risk of failure.
The study design is a prospective randomized study with equal groups.
A power analysis has been performed indicating that 57 patients in each group are required to detect a significant difference between groups, as such a cohort of 120 patients will be recruited. Randomisation will continue until 60 patients are allocated to both groups.
Randomization process and study design will be done according to the CONSORT guidelines.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Meniscal tear in the peripheral zone of the meniscus, repaired using at least two sutures.
Exclusion Criteria
- •Associated injury of the knee requiring surgical or non-surgical intervention that precludes the patient from completing accelerated rehabilitation- fracture, concomitant ligament or cartilage injury.
- •Previous meniscal repair in the affected meniscus
- •BMI over 30
Outcomes
Primary Outcomes
Change from baseline Biodex isokinetic quadriceps strength at 6 months
Time Frame: six months
Patients will undergo Biodex Isokinetic measurement at 6 months
Secondary Outcomes
- Change from baseline Biodex isokinetic quadriceps strength at 24 months(2 years)
- Goniometric measurement: Knee flexion and extension(2 weeks, 6 weeks, 6 months, 2 years)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(preoperative, six months, two years)
- IKDC(Pre-operative, 6 months, 2 years)
- Rates of failure(two years)
- Tegner activity score(Pre-operative, 6 months, 2 years)
- Measurement of circumference of the knee(Pre-operative, 6 weeks, 3 months, 6 months, 2 years)
- Lysholm score(Pre-operative, 6 months, 2 years)
- Functional knee tests(6 weeks, 6 months, 2 years)
Investigators
Anders Stalman
Associate professor
Karolinska Institutet