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CompletedNCT00823888Updated Jul 20, 2011

Mechanics of Knee Bracing

An interventional study of pneumatic brace in Osteoarthritis, Knee, sponsored by The New England Baptist Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-20.

Sponsored by The New England Baptist Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Osteoarthritis, Knee

Keywords

  • Knee Osteoarthritis
  • pneumatic bracing
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 20 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

The New England Baptist Hospital is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Interventions

  • Devicepneumatic brace

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

06

What researchers measure

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

07

Study locations

1 site
  • New England Baptist Hospital
    Boston, Massachusetts 02120, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00823888
Lead sponsor
The New England Baptist Hospital
Collaborators
Boston University, Spaulding Rehabilitation Hospital
First posted
Jan 16, 2009
Start date
Sep 2008
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Jul 20, 2011

Study contacts

William F Harvey, MD
principal investigator · New England Baptist Hospital, Tufts Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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