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OpenTrials
Completed

NCT Number: NCT00823888

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

pneumatic brace

Device

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

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.

    Time frame: 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.

    Time frame: During study visit

Sponsors and collaborators

Lead sponsor

The New England Baptist Hospital

Other

Collaborators

  • Boston University
  • Spaulding Rehabilitation Hospital

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 16, 2009
Registry last updated
Jul 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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