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

February 6, 2013 updated by: Dianne Bryant, University of Western Ontario, Canada

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre - University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Knee Arthroscopy + HTO
Procedure: knee Arthroscopy
Patient undergoes a knee arthroscopy and HTO
Active Comparator: HTO Alone
Other: No arthroscopy
Patient undergoes an HTO without knee arthroscopy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The Lower Extremity Functional Scale (LEFS)
Time Frame: Preoperatively; 3, 6, 12, 18 and 24 months
Preoperatively; 3, 6, 12, 18 and 24 months
Patient Diary to asses swelling, pain and frequency of analgesic and NSAID use.
Time Frame: Daily x 2 weeks post surgery; Weekly x 3 months
Daily x 2 weeks post surgery; Weekly x 3 months
SF-12
Time Frame: Preoperatively; 3, 6, 12, 18 and 24 months
Preoperatively; 3, 6, 12, 18 and 24 months
Gait Testing Procedures
Time Frame: 6, 12 and 24 months post-operatively
6, 12 and 24 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Western Ontario, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (Estimate)

June 7, 2012

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKSMC 2010 - 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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