Mechanics of Knee Bracing

NCT00823888 | Completed

• 1 other identifier: NEBH 2008-012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Knee Osteoarthritis; pneumatic bracing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

pneumatic brace DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The New England Baptist Hospital: lead
• Boston University: collaborator
• Spaulding Rehabilitation Hospital: collaborator

Study Sites (1)

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• William F Harvey, MD

  New England Baptist Hospital, Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 16, 2009
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 20, 2011

Record last verified: 2011-07

Locations

US (1)