High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint

Not Applicable

Withdrawn

• Conditions: Medial Compartment Osteoarthritis of the Knee
• Interventions: Procedure: knee Arthroscopy; Other: No arthroscopy

• 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

Study Timeline

• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-07
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-08

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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
Knee Arthroscopy + HTO	knee Arthroscopy	-
HTO Alone	No arthroscopy	-

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