Mechanics of Knee Bracing

This study has been completed.

Sponsor:

Collaborators:

Boston University

Spaulding Rehabilitation Hospital

Information provided by:

The New England Baptist Hospital

ClinicalTrials.gov Identifier:

NCT00823888

First received: January 15, 2009

Last updated: July 19, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 15, 2009

Last Updated Date

July 19, 2011

Start Date ^ICMJE

September 2008

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00823888 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Mechanics of Knee Bracing

Official Title ^ICMJE

Mechanics of Knee Bracing

Brief Summary

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

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Osteoarthritis, Knee

Intervention ^ICMJE

Device: pneumatic brace

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00823888

Other Study ID Numbers ^ICMJE

NEBH 2008-012

Has Data Monitoring Committee

Responsible Party

William F Harvey, MD, New England Baptist Hospital

Study Sponsor ^ICMJE

The New England Baptist Hospital

Collaborators ^ICMJE

Boston University
Spaulding Rehabilitation Hospital

Investigators ^ICMJE

Principal Investigator:

William F Harvey, MD

New England Baptist Hospital, Tufts Medical Center

Information Provided By

The New England Baptist Hospital

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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