Mechanics of Knee Bracing

July 19, 2011 updated by: The New England Baptist Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

20

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • New England Baptist 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:

  • 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)

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
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To undertake a clinical trial in patients with medial knee OA to determine whether provision of a pneumatic knee brace leads to a reduced adduction moment during the time of this treatment than during the use of a control treatment.
Time Frame: At study visit
At study visit

Secondary Outcome Measures

Outcome Measure
Time Frame
To undertake a clinical trial in patients with medial knee OA to determine whether provision of a pneumatic knee brace leads to a lower pain score and improved function during the time of this treatment than during the use of a control treatment.
Time Frame: During study visit
During study visit

Collaborators and Investigators

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

Sponsor

The New England Baptist Hospital

Collaborators

Boston University
Spaulding Rehabilitation Hospital

Investigators

  • Principal Investigator: William F Harvey, MD, New England Baptist Hospital, Tufts Medical Center

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 Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

January 15, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (Estimate)

January 16, 2009

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEBH 2008-012

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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