Rehabilitation With or Without Knee Orthosis Following Meniscal Repair

Meniscal Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557916
• Other study ID #: Meniscal suture orthosis study
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2022
• Source: Karolinska Institutet
• Contact: Sebastian D McCallum, MBBS
• Phone: +46760393379
• Email: mccallum.seb[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Meniscal Tear

Intervention

Other:
• Standard rehab
Standard rehab protocol including knee orthosis following meniscal repair
• accelerated rehab group
accelerated rehab group, no orthosis

Locations

Country	Name	City	State
Sweden	Centrum för idrottsforskning och utbildning (CIFU)	Stockholm
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Biodex isokinetic quadriceps strength at 6 months	Patients will undergo Biodex Isokinetic measurement at 6 months	six months
Secondary	Rates of failure	Rates of failure, defined as reoperation with meniscal resection within two years of the repair.	two years
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS)	Patients will complete the KOOS at specific time points to evaluate subjective knee function throughout treatment. Score range from 0 to 100, with higher scores indicating better results	preoperative, six months, two years
Secondary	Change from baseline Biodex isokinetic quadriceps strength at 24 months	Patients will undergo Biodex Isokinetic measurement at 24 months	2 years
Secondary	Goniometric measurement: Knee flexion and extension	Patients will undergo Goniometric measurement at specific time points to evaluate knee range of motion	2 weeks, 6 weeks, 6 months, 2 years
Secondary	IKDC	Patients will complete the IKDC at specific time points to evaluate subjective knee function throughout treatment. Score range from 0 to 100, with higher scores indicating better results	Pre-operative, 6 months, 2 years
Secondary	Tegner activity score	Patients will complete the Tegner activity score at specific time points to evaluate Activity in sports throughout treatment, Assesses activity level with specific emphasis on knee; scores range from 1 (least strenuous activity) to 10 (high knee demanding activity on professional sports level)	Pre-operative, 6 months, 2 years
Secondary	Lysholm score	Patients will complete the Lysholm score at specific time points to evaluate subjective knee function throughout treatment. Score range from 0 to 100, with higher scores indicating better results	Pre-operative, 6 months, 2 years
Secondary	Measurement of circumference of the knee	Circumference of the knee will be measured at mid-patella and 15cm above superior border of patella. They will be compared with contralateral knee to compare swelling.	Pre-operative, 6 weeks, 3 months, 6 months, 2 years
Secondary	Functional knee tests	patients will undergo functional knee tests (ie Single hop test for difference, 30s chair-stand test	6 weeks, 6 months, 2 years