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
  Purpose

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.


Condition Intervention
Osteoarthritis, Knee
Device: pneumatic brace

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mechanics of Knee Bracing

Resource links provided by NLM:


Further study details as provided by The New England Baptist Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: pneumatic brace
    pneumatic knee brace with three trial conditions: air bladders inflated at 0psi, 7 psi, and 12 psi
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823888

Locations
United States, Massachusetts
New England Baptist Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
The New England Baptist Hospital
Boston University
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: William F Harvey, MD New England Baptist Hospital, Tufts Medical Center
  More Information

No publications provided

Responsible Party: William F Harvey, MD, New England Baptist Hospital
ClinicalTrials.gov Identifier: NCT00823888     History of Changes
Other Study ID Numbers: NEBH 2008-012
Study First Received: January 15, 2009
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The New England Baptist Hospital:
Knee Osteoarthritis
pneumatic bracing

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 29, 2014