Knee Bracing for People With Patellofemoral Osteoarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00381563
• Date of registration: 27/09/2006
• Primary sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Public title: Knee Bracing for People With Patellofemoral Osteoarthritis
• Scientific title: Bracing in Patellofemoral Osteoarthritis: A Clinical Trial
• Date of first enrolment: December 2006
• Target sample size: 80
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00381563
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: David Hunter, MD
• Affiliation: Boston University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Knee pain on most days

- Either isolated patellofemoral osteoarthritis or mixed patellofemoral and
tibiofemoral osteoarthritis, as based on x-ray

Exclusion Criteria:

- Bed- or chair-bound, usually uses an ambulation aid to walk (e.g., cane, crutch, or
walker), or uses a wheelchair

- Pain emanating more from the back or hip than from the knee, as determined by
screening questionnaire

- Low pain score on the visual analog scale (VAS) (less than 4 out of 10)

- Plans to move from the area within 10 months of study screening

- Symptomatic comorbid disease that limits activities more than knee pain does, as
determined by screening questionnaire (e.g., congestive heart failure, chronic
obstructive pulmonary disease)

- Receiving corticosteroid injections in the month before study entry, or receiving
hyaluronan in the 6-month period before study entry. No other treatments will result
in exclusion, although for patients taking glucosamine and/or chondroitin and/or a
non-steroidal anti-inflammatory drug (NSAID), they must have taken these treatments
for at least 2 months before study entry and must commit to not start a new treatment
during the study.

- Bilateral total knee replacements or plans for a total knee replacement of the
affected knee in the next 6 months

- Morbidly obese (body mass index greater than 35), as brace fitting and prevention of
slippage of the brace will be difficult

- Known other causes of arthritis, including rheumatoid arthritis, systemic lupus
erythematosus, gout, psoriatic arthritis, and pseudogout

- Skin breakdown at the site where the brace will be applied

- Failure to pass the run-in test, or the brace falls down the leg during the run-in



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Knee Osteoarthritis

Intervention(s)

Device: Non-aligning knee brace

Device: Patellofemoral realigning knee brace

Primary Outcome(s)

Change in pain on the visual analog scale (VAS) [Time Frame: Measured at 6 weeks]

Secondary Outcome(s)

Analgesic use [Time Frame: Measured at 6 weeks]

Blinded knee [Time Frame: Measured at 6 weeks]

Functional performance [Time Frame: Measured at 6 weeks]

Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time Frame: Measured at 6 weeks]

Knee strength [Time Frame: Measured at 6 weeks]

Pain with activity [Time Frame: Measured at 6 weeks]

Patient assessment [Time Frame: Measured at 6 weeks]

Physical activity [Time Frame: Measured at 6 weeks]

Physical Activity Scale for the Elderly (PASE) [Time Frame: Measured at 6 weeks]

Physical function [Time Frame: Measured at 6 weeks]

Physician assessment [Time Frame: Measured at 6 weeks]

Short Form (36) Health Survey (SF-36) [Time Frame: Measured at 6 weeks]

Western Ontario and McMaster Osteoarthritis Index (WOMAC) [Time Frame: Measured at 6 weeks]

X-ray [Time Frame: Measured at 6 weeks]

Secondary ID(s)

2 P60 AR047785-06

P60 AR047785

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boston University