Mechanics of Knee Bracing

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; (submitted: January 15, 2009)	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; (submitted: January 15, 2009)	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; (submitted: January 15, 2009)	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: 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)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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	Boston University; Spaulding Rehabilitation Hospital
Investigators ICMJE	Principal Investigator: William F Harvey, MD New England Baptist Hospital, Tufts Medical Center
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