Mechanics of Knee Bracing

NCT ID: NCT00823888

Last Updated: 2011-07-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-09-30

Brief Summary

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The overall objective of this project is to determine whether the provision of a pneumatic knee brace in patients with medial knee osteoarthritis (OA) improves knee mechanics. Secondary objectives will be to assess if the brace relieves knee pain and improves function. We will test the hypothesis that compared to the control treatment (see below for the definition) the use of a pneumatic knee brace is effective in medial knee OA.

Detailed Description

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This study is closed to enrollment and in the data analysis phase

Conditions

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Osteoarthritis, Knee

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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pneumatic brace

pneumatic knee brace with three trial conditions: air bladders inflated at 0psi, 7 psi, and 12 psi

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* knee pain, aching or stiffness on most of the past 30 days
* x-ray verified predominant medial tibiofemoral osteoarthritis (TFOA)
* overall pain that is due to the medial TFOA (versus being referred from the back, hips, or other pre-existing conditions)
* ambulatory persons

Exclusion Criteria

* use of a crutch, walker, or wheelchair or cane more than 50% of the time
* history of Deep Vein Thrombosis
* Pain emanating more from back or hip than from knee
* Low pain score on WOMAC
* predominant patellofemoral disease or knee pathology other than medial compartment OA likely to be causing their knee pain.
* Planning to move from area within 1 month of study screening.
* Unable to fit the brace properly
* BMI greater than 35
* corticosteriod injections in the past month
* Bilateral total knee replacements or plan for TKR
* Other types of arthritis including Rheumatoid Arthritis, Systemic Lupus Erythematosus, gout, psoriatic arthritis, pseudogout.
* woman who are pregnant (due to x-rays taken to determine eligibility)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston University

OTHER

Sponsor Role collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role collaborator

The New England Baptist Hospital

OTHER

Sponsor Role lead

Responsible Party

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New England Baptist Hospital

Principal Investigators

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William F Harvey, MD

Role: PRINCIPAL_INVESTIGATOR

New England Baptist Hospital, Tufts Medical Center

Locations

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New England Baptist Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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NEBH 2008-012

Identifier Type: -

Identifier Source: org_study_id

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