Osteoarthritis, KneeNCT00823888
Mechanics of Knee Bracing
A study testing pneumatic brace in people with Osteoarthritis, Knee, run by The New England Baptist Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- pneumatic brace
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
New England Baptist Hospital
Boston, Massachusetts, 02120
About this study
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
- Conditions
- Osteoarthritis, Knee
- Being tested
- pneumatic brace
- Keywords
- Knee Osteoarthritis, pneumatic bracing
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumatic braceDevice
pneumatic knee brace with three trial conditions: air bladders inflated at 0psi, 7 psi, and 12 psi
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New England Baptist Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, Spaulding Rehabilitation Hospital
- Investigators
- William F Harvey, MD, Principal investigator, New England Baptist Hospital, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823888
- Sponsor's protocol ID
- NEBH 2008-012
- Status last verified
- Jul 2011
- First submitted
- 15 Jan 2009
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanics of Knee Bracing
- ClinicalTrials.gov ID
- NCT00823888
- Acronym / sponsor ID
- NEBH 2008-012
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee Osteoarthritis, pneumatic bracing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The New England Baptist HospitalUniversity, hospital or other
- Collaborators
- Boston University, Spaulding Rehabilitation Hospital
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pneumatic bracepneumatic knee brace with three trial conditions: air bladders inflated at 0psi, 7 psi, and 12 psi | Device | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William F Harvey, MD principal investigator
New England Baptist Hospital, Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pneumatic brace in people with Osteoarthritis, Knee, run by The New England Baptist Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.