Mechanics of Knee Bracing

Osteoarthritis, Knee Clinical Trial

Official title:

Mechanics of Knee Bracing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823888
• Other study ID #: NEBH 2008-012
• Status: Completed
• Phase: N/A
• First received: January 15, 2009
• Last updated: July 19, 2011
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: July 2011
• Source: The New England Baptist Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	New England Baptist Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
The New England Baptist Hospital	Boston University, Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		At study visit
Secondary	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.		During study visit