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

Primary Purpose

Medial Compartment Osteoarthritis of the Knee

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
knee Arthroscopy
No arthroscopy
Sponsored by
University of Western Ontario, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medial Compartment Osteoarthritis of the Knee focused on measuring HTO, Arthroscopy, Quality-of-Life, Gait Analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Health Sciences Centre - University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Knee Arthroscopy + HTO

HTO Alone

Arm Description

Outcomes

Primary Outcome Measures

WOMAC

Secondary Outcome Measures

The Lower Extremity Functional Scale (LEFS)
Patient Diary to asses swelling, pain and frequency of analgesic and NSAID use.
SF-12
Gait Testing Procedures

Full Information

First Posted
June 4, 2012
Last Updated
February 6, 2013
Sponsor
University of Western Ontario, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01614288
Brief Title
High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Western Ontario, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medial Compartment Osteoarthritis of the Knee
Keywords
HTO, Arthroscopy, Quality-of-Life, Gait Analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Knee Arthroscopy + HTO
Arm Type
Active Comparator
Arm Title
HTO Alone
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
knee Arthroscopy
Intervention Description
Patient undergoes a knee arthroscopy and HTO
Intervention Type
Other
Intervention Name(s)
No arthroscopy
Intervention Description
Patient undergoes an HTO without knee arthroscopy
Primary Outcome Measure Information:
Title
WOMAC
Time Frame
Preoperatively; 3, 6, 12, 18 and 24 months
Secondary Outcome Measure Information:
Title
The Lower Extremity Functional Scale (LEFS)
Time Frame
Preoperatively; 3, 6, 12, 18 and 24 months
Title
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
Title
SF-12
Time Frame
Preoperatively; 3, 6, 12, 18 and 24 months
Title
Gait Testing Procedures
Time Frame
6, 12 and 24 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dianne Bryant, PhD
Organizational Affiliation
The University of Western Ontario
Official's Role
Study Director
Facility Information:
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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

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