Bracing for Patellofemoral Osteoarthritis

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.

Conditions

• Knee Osteoarthritis
• Metabolic Disease

Interventions

DEVICE

Womac

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

DEVICE

Lequesne

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

DEVICE

Timed-up-and-go (TUG)

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

DEVICE

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

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

DEVICE

Six-minute walk test.

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

DEVICE

functional patellofemoral neoprene brace

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

DEVICE

neoprene sleeve brace.

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Marcia U Rezende, MD; PhD · Department of Orthopedics and Traumatology - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-20

Primary Completion

2018-10-30

Completion

2018-12-30