Rehabilitation With or Without Knee Orthosis Following Meniscal Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-31

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.

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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.

Conditions

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Meniscal Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised control trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard rehab group

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.

Group Type ACTIVE_COMPARATOR

Standard rehab

Intervention Type OTHER

Standard rehab protocol including knee orthosis following meniscal repair

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

Group Type ACTIVE_COMPARATOR

accelerated rehab group

Intervention Type OTHER

accelerated rehab group, no orthosis

Interventions

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Standard rehab

Standard rehab protocol including knee orthosis following meniscal repair

Intervention Type OTHER

accelerated rehab group

accelerated rehab group, no orthosis

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes