Rehabilitation With or Without Knee Orthosis Following Meniscal Repair

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised Control Trial of Rehabilitation With or Without a Knee Orthosis Following Meniscal Repair

Conditions
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Meniscal Tear

Intervention / Treatment
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* Other: Standard rehab
* Other: accelerated rehab group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard rehab group<br>This group will follow the clinics standard rehab protocol, wherein they have a knee orthosis for six weeks, with flexion limited to 0-30 degress week 0-2, 0-60 degrees week 2-4 and 0-90 degrees week 4-6. Crouching is not permitted week 6-12. | Other: Standard rehab<br>* Standard rehab protocol including knee orthosis following meniscal repair<br>|
| Active Comparator: Accelerated rehab group<br>accelerated rehab group, wherein they are permitted to perform range of motion training within their comfort zone. Running is permitted after 8 weeks, contact sports 4 months postoperatively | Other: accelerated rehab group<br>* accelerated rehab group, no orthosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Biodex isokinetic quadriceps strength at 6 months | Patients will undergo Biodex Isokinetic measurement at 6 months | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of failure | Rates of failure, defined as reoperation with meniscal resection within two years of the repair. | 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 | preoperative, six months, two years | 
| Change from baseline Biodex isokinetic quadriceps strength at 24 months | Patients will undergo Biodex Isokinetic measurement at 24 months | 2 years | 
| Goniometric measurement: Knee flexion and extension | Patients will undergo Goniometric measurement at specific time points to evaluate knee range of motion | 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 | 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) | 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 | 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. | 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 | 6 weeks, 6 months, 2 years |