Rehabilitation With or Without Knee Orthosis Following Meniscal Repair

Not Applicable

Recruiting

• Conditions: Meniscal Tear
• Interventions: Other: accelerated rehab group; Other: Standard rehab

• Registration Number: NCT05557916
• Lead Sponsor: Karolinska Institutet

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 Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-02-20
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-26
• Last Update Submitted: 2022-09-26
• Study First Posted: 2022-09-28
• Last Update Posted: 2022-09-28
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accelerated rehab group	accelerated rehab group	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
Standard rehab group	Standard rehab	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline Biodex isokinetic quadriceps strength at 6 months	six months	Patients will undergo Biodex Isokinetic measurement at 6 months

Secondary Outcome Measures

Name	Time	Method
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
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
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.
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)
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.
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
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

Trial Locations

Locations (2)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Centrum för idrottsforskning och utbildning (CIFU); 🇸🇪 Stockholm, Sweden