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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

January 15, 2009
July 19, 2011
September 2008
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00823888 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Mechanics of Knee Bracing
Mechanics of Knee Bracing

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.

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

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis, Knee
Device: pneumatic brace
pneumatic knee brace with three trial conditions: air bladders inflated at 0psi, 7 psi, and 12 psi
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2009
September 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00823888
NEBH 2008-012
No
William F Harvey, MD, New England Baptist Hospital
The New England Baptist Hospital
  • Boston University
  • Spaulding Rehabilitation Hospital
Principal Investigator: William F Harvey, MD New England Baptist Hospital, Tufts Medical Center
The New England Baptist Hospital
July 2011

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