A Randomized Clinical Trial to Compare the Effectiveness of High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint on Quality of Life, Function, Pain and Swelling for Patients With Medical Compartment Osteoarthritis of the Knee

University of Western Ontario, Canada1 site in 1 countryJune 7, 2012

ConditionsMedial Compartment Osteoarthritis of the Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Medial Compartment Osteoarthritis of the Knee
Sponsor: University of Western Ontario, Canada
Locations: 1
Primary Endpoint: WOMAC
Status: Withdrawn
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 7, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Western Ontario, Canada

Responsible Party

Principal Investigator

Dianne Bryant

Associate Professor

University of Western Ontario, Canada

Eligibility Criteria

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

Outcomes

Primary Outcomes

WOMAC

Time Frame: Preoperatively; 3, 6, 12, 18 and 24 months

Secondary Outcomes

SF-12(Preoperatively; 3, 6, 12, 18 and 24 months)
Gait Testing Procedures(6, 12 and 24 months post-operatively)
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)