Suspended

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

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What is being tested

Standard rehab

+ accelerated rehab group

Other
Who is being recruted

From 18 to 40 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2022
See protocol details

Summary

Principal SponsorKarolinska Institutet
Study ContactSebastian D McCallum, MBBSMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2022

Actual date on which the first participant was enrolled.

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 TitleA Randomised Control Trial of Rehabilitation With or Without a Knee Orthosis Following Meniscal Repair
NCT05557916
Principal SponsorKarolinska Institutet
Study ContactSebastian D McCallum, MBBSMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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 II

Active Comparator
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Centrum för idrottsforskning och utbildning (CIFU)

Stockholm, SwedenOpen Centrum för idrottsforskning och utbildning (CIFU) in Google Maps
Recruiting

Karolinska University Hospital

Stockholm, Sweden
Suspended2 Study Centers