Trials / Unknown
UnknownNCT05557916
Rehabilitation With or Without Knee Orthosis Following Meniscal Repair
A Randomised Control Trial of Rehabilitation With or Without a Knee Orthosis Following Meniscal Repair
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Karolinska Institutet · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Standard rehab | Standard rehab protocol including knee orthosis following meniscal repair |
| OTHER | accelerated rehab group | accelerated rehab group, no orthosis |
Timeline
- Start date
- 2022-01-01
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2022-09-28
- Last updated
- 2022-09-28
Locations
2 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT05557916. Inclusion in this directory is not an endorsement.