Rehabilitation With or Without Knee Orthosis Following Meniscal Repair

Karolinska Institute

Status: Enrolling

Conditions: Meniscal Tear

Treatments: Other: accelerated rehab group; Other: Standard rehab

Study type: Interventional

Funder types: Other

Identifiers

NCT05557916

Meniscal suture orthosis study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Standard rehab group

Active Comparator group

Description:

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.

Treatment:

Other: Standard rehab

Accelerated rehab group

Active Comparator group

Description:

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

Treatment:

Other: accelerated rehab group