Rehabilitation With or Without Knee Orthosis Following Meniscal Repair

NCT05557916 | Unknown

• 1 other identifier: Meniscal suture orthosis study
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Meniscal Tear

Outcome Measures

Primary Outcomes (1)

• Change from baseline Biodex isokinetic quadriceps strength at 6 months

  Patients will undergo Biodex Isokinetic measurement at 6 months

  six months

Secondary Outcomes (9)

• Rates of failure

  two years

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  preoperative, six months, two years

• Change from baseline Biodex isokinetic quadriceps strength at 24 months

  2 years

• Goniometric measurement: Knee flexion and extension

  2 weeks, 6 weeks, 6 months, 2 years

• IKDC

  Pre-operative, 6 months, 2 years

Study Arms (2)

Standard rehab group

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.

Other: Standard rehab

Accelerated rehab group

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

Other: accelerated rehab group

Interventions

Standard rehab OTHER

Standard rehab protocol including knee orthosis following meniscal repair

Standard rehab group

accelerated rehab group OTHER

accelerated rehab group, no orthosis

Accelerated rehab group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Meniscal tear in the peripheral zone of the meniscus, repaired using at least two sutures.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (2)

Centrum för idrottsforskning och utbildning (CIFU)

Stockholm, 11427, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, 141 86, Sweden

RECRUITING

Study Officials

• Erik Rönnblad

  Centrum för idrottsforskning och utbildning (CIFU) Adress: Valhallavägen 91, 11427 Stockholm

  STUDY DIRECTOR

Central Study Contacts

Sebastian D McCallum, MBBS

CONTACT

+46760393379; mccallum.seb@gmail.com

Christoffer Von Essen, MD

CONTACT

christoffer.vonessen@capio.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Randomised control trial

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: September 28, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)