Mechanics of Knee Bracing
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00823888 |
Recruitment Status
:
Completed
First Posted
: January 16, 2009
Last Update Posted
: July 20, 2011
|
Sponsor:
The New England Baptist Hospital
Collaborators:
Boston University
Spaulding Rehabilitation Hospital
Information provided by:
The New England Baptist Hospital
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | January 15, 2009 | |||
First Posted Date ICMJE | January 16, 2009 | |||
Last Update Posted Date | July 20, 2011 | |||
Study Start Date ICMJE | September 2008 | |||
Actual 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 ] | |||
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 ] | |||
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 Applicable | |||
Study Design ICMJE | Intervention Model: Crossover Assignment Masking: None (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 Arms | 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 | |||
Actual Enrollment ICMJE |
20 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | September 2009 | |||
Actual Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
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 | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | William F Harvey, MD, New England Baptist Hospital | |||
Study Sponsor ICMJE | The New England Baptist Hospital | |||
Collaborators ICMJE |
|
|||
Investigators ICMJE |
|
|||
PRS Account | 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 |