Clinical trial NCT05557916: Rehabilitation With or Without Knee Orthosis Following Meniscal Repair
Official title: A Randomised Control Trial of Rehabilitation With or Without a Knee Orthosis Following Meniscal Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meniscal Tear
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised control trial
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline Biodex isokinetic quadriceps strength at 6 months
timeFrame: six months
Secondary outcomes:
measure: Rates of failure
timeFrame: two years
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: preoperative, six months, two years
measure: Change from baseline Biodex isokinetic quadriceps strength at 24 months
timeFrame: 2 years
measure: Goniometric measurement: Knee flexion and extension
timeFrame: 2 weeks, 6 weeks, 6 months, 2 years
measure: IKDC
timeFrame: Pre-operative, 6 months, 2 years
measure: Tegner activity score
timeFrame: Pre-operative, 6 months, 2 years
measure: Lysholm score
timeFrame: Pre-operative, 6 months, 2 years
measure: Measurement of circumference of the knee
timeFrame: Pre-operative, 6 weeks, 3 months, 6 months, 2 years
measure: Functional knee tests
timeFrame: 6 weeks, 6 months, 2 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Centrum för idrottsforskning och utbildning (CIFU)
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Centrum för idrottsforskning och utbildning (CIFU) Adress: Valhallavägen 91, 11427 Stockholm
name: Erik Rönnblad
role: STUDY_DIRECTOR
References: