CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
Womac +6 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02984254
NCT02984254N/ACompleted

Bracing for Patellofemoral Osteoarthritis. A Prospective Randomized Study of the Treatment of Patellofemoral Arthritis by an Orthosis

University of Sao Paulo General Hospital·interventional·Posted Dec 6, 2016·Updated Jan 25, 2019

In Brief

A clinical study evaluating Womac, Lequesne, and 5 other interventions for Knee Osteoarthritis and Metabolic Disease. Completed, enrolled 52 participants.

Detailed Summary

BACKGROUND: Despite the prevalence of patellofemoral ostearthritis (OA), this joint has received relatively little attention in the OA literature and there are few treatment options for individuals with patellofemoral OA. Patellar misalignment is associated with radiographic progression patellofemoral OA and symptoms and in magnetic resonance imaging (MRI), to cartilage loss measurements and bone marrow lesions. The hypothesis is that the correction of the patella disorder using strategies such as bracing or adhesive bandages can handle the symptoms and progression of OA. OBJECTIVE: To compare the effect of a brace designed to stabilize the patellofemoral joint compared with a neoprene sleeve with kneecap opening in patients with patellofemoral OA. METHODS: Fifty-two patients with patellofemoral OA and co-morbidities (Two or more of: overweight or obesity, hyperglycemia, dyslipidemia, hyperuricemia, high blood pressure) will be divided into two groups according to the knee brace that will receive: Functional Bracing patellofemoral (group 1) and neoprene knee sleeve with patella opening (group 2). Both groups will be oriented on the clinical treatment of osteoarthritis and metabolic syndrome and asked to do daily exercises in addition to reporting the daily consumption of drugs a month before placing the orthotics up to three months after placing it. They will be evaluated with the questionnaires WOMAC and Lequesne, and asked to perform the five-times-sit-to-stand-test, Timed-up-and-go (TUG) and the six-minute walk test in the moments immediately prior to placement of the brace, with one, three and after 12 months bracing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 6, 2016
Enrollment StartDec 20, 2016
Primary CompletionOct 30, 2018
Study CompletionDec 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.6 years ago

Interventions

Womacdevice

Answer Womac questionnaires at baseline, 1 month, 3 months and 1 year

Lequesnedevice

Answer Lequesne questionnaires at baseline, 1 month, 3 months and 1 year

Timed-up-and-go (TUG)device

Perform Timed-up-and-go (TUG) at baseline, 1 month, 3 months and 1 year

five-times-sit-to-stand-test (FTSST)device

Perform the five-times-sit-to-stand-test (FTSST) at baseline, 1 month, 3 months and 1 year

Six-minute walk test.device

Perform six-minute walk test at baseline, 3 months and 1 year

functional patellofemoral neoprene bracedevice

Use the functional patellofemoral neoprene brace for 2 hours/day minimum - 12 hours/day maximum

neoprene sleeve brace.device

Use the neoprene sleeve brace for 2 hours/day minimum - 12 hours/day maximum