Meniscal Tear
Conditions
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.
Interventions
OTHERStandard rehab
Standard rehab protocol including knee orthosis following meniscal repair
OTHERaccelerated rehab group
accelerated rehab group, no orthosis
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Biodex isokinetic quadriceps strength at 6 months | six months | Patients will undergo Biodex Isokinetic measurement at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee injury and Osteoarthritis Outcome Score (KOOS) | preoperative, six months, two years | Patients will complete the KOOS at specific time points to evaluate subjective knee function throughout treatment. Score range from 0 to 100, with higher scores indicating better results |
| Change from baseline Biodex isokinetic quadriceps strength at 24 months | 2 years | Patients will undergo Biodex Isokinetic measurement at 24 months |
| Goniometric measurement: Knee flexion and extension | 2 weeks, 6 weeks, 6 months, 2 years | Patients will undergo Goniometric measurement at specific time points to evaluate knee range of motion |
| IKDC | Pre-operative, 6 months, 2 years | Patients will complete the IKDC at specific time points to evaluate subjective knee function throughout treatment. Score range from 0 to 100, with higher scores indicating better results |
| Rates of failure | two years | Rates of failure, defined as reoperation with meniscal resection within two years of the repair. |
| Lysholm score | Pre-operative, 6 months, 2 years | Patients will complete the Lysholm score at specific time points to evaluate subjective knee function throughout treatment. Score range from 0 to 100, with higher scores indicating better results |
| Measurement of circumference of the knee | Pre-operative, 6 weeks, 3 months, 6 months, 2 years | Circumference of the knee will be measured at mid-patella and 15cm above superior border of patella. They will be compared with contralateral knee to compare swelling. |
| Functional knee tests | 6 weeks, 6 months, 2 years | patients will undergo functional knee tests (ie Single hop test for difference, 30s chair-stand test |
| Tegner activity score | Pre-operative, 6 months, 2 years | Patients will complete the Tegner activity score at specific time points to evaluate Activity in sports throughout treatment, Assesses activity level with specific emphasis on knee; scores range from 1 (least strenuous activity) to 10 (high knee demanding activity on professional sports level) |
Countries
Sweden
Contacts
Primary ContactSebastian D McCallum, MBBS
Backup ContactChristoffer Von Essen, MD
Outcome results
None listed