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

NCT ID: NCT01614288

Last Updated: 2013-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Medial Compartment Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Knee Arthroscopy + HTO

Group Type ACTIVE_COMPARATOR

knee Arthroscopy

Intervention Type PROCEDURE

Patient undergoes a knee arthroscopy and HTO

HTO Alone

Group Type ACTIVE_COMPARATOR

No arthroscopy

Intervention Type OTHER

Patient undergoes an HTO without knee arthroscopy

Interventions

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knee Arthroscopy

Patient undergoes a knee arthroscopy and HTO

Intervention Type PROCEDURE

No arthroscopy

Patient undergoes an HTO without knee arthroscopy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Western Ontario, Canada

OTHER

Sponsor Role lead

Responsible Party

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Dianne Bryant

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dianne Bryant, PhD

Role: STUDY_DIRECTOR

The University of Western Ontario

Locations

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London Health Sciences Centre - University Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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FKSMC 2010 - 2

Identifier Type: -

Identifier Source: org_study_id

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