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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Standard rehab protocol including knee orthosis following meniscal repair
accelerated rehab group, no orthosis
Centrum för idrottsforskning och utbildning (CIFU)
Stockholm, Sweden
RECRUITINGKarolinska University Hospital
Stockholm, Sweden
RECRUITINGChange from baseline Biodex isokinetic quadriceps strength at 6 months
Patients will undergo Biodex Isokinetic measurement at 6 months
Time frame: six months
Rates of failure
Rates of failure, defined as reoperation with meniscal resection within two years of the repair.
Time frame: two years
Knee injury and Osteoarthritis Outcome Score (KOOS)
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
Time frame: preoperative, six months, two years
Change from baseline Biodex isokinetic quadriceps strength at 24 months
Patients will undergo Biodex Isokinetic measurement at 24 months
Time frame: 2 years
Goniometric measurement: Knee flexion and extension
Patients will undergo Goniometric measurement at specific time points to evaluate knee range of motion
Time frame: 2 weeks, 6 weeks, 6 months, 2 years
IKDC
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
Time frame: Pre-operative, 6 months, 2 years
Tegner activity score
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)
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Time frame: Pre-operative, 6 months, 2 years
Lysholm score
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
Time frame: Pre-operative, 6 months, 2 years
Measurement of circumference of the knee
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.
Time frame: Pre-operative, 6 weeks, 3 months, 6 months, 2 years
Functional knee tests
patients will undergo functional knee tests (ie Single hop test for difference, 30s chair-stand test
Time frame: 6 weeks, 6 months, 2 years