High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint
Not Applicable
Withdrawn
- Conditions
- Medial Compartment Osteoarthritis of the Knee
- Registration Number
- NCT01614288
- Lead Sponsor
- University of Western Ontario, Canada
- Brief Summary
Participants will be randomized to undergo a High Tibial Osteotomy (HTO) with or without a knee scope. Patients will be tested in the Gait Lab, will fill out quality-of-life questionnaires, and have a clinical evaluation done preoperative and at each follow-up visit.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- All patients booked for an HTO due to OA
- Grades II to IV severity of OA by radiographic evaluation (Kellgren & Lawrence grade)
- OA of the knee primarily involving the medial compartment
Exclusion Criteria
- Imaging evidence of significant knee joint pathology that would change the decision to do an HTO
- An arthroscopy of the knee within 2 years of planned surgery
- Active joint or systemic infection,
- Major medical illness that would preclude undergoing surgery,
- Patients who are unwilling or unable to be assessed according to study protocol for two years following surgery
- Major psychiatric illness, developmental handicap or inability to read and understand the English language
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method WOMAC Preoperatively; 3, 6, 12, 18 and 24 months
- Secondary Outcome Measures
Name Time Method The Lower Extremity Functional Scale (LEFS) Preoperatively; 3, 6, 12, 18 and 24 months Patient Diary to asses swelling, pain and frequency of analgesic and NSAID use. Daily x 2 weeks post surgery; Weekly x 3 months SF-12 Preoperatively; 3, 6, 12, 18 and 24 months Gait Testing Procedures 6, 12 and 24 months post-operatively
Trial Locations
- Locations (1)
London Health Sciences Centre - University Hospital
🇨🇦London, Ontario, Canada
London Health Sciences Centre - University Hospital🇨🇦London, Ontario, Canada