Bracing for Patellofemoral Osteoarthritis. A Prospective Randomized Study of the Treatment of Patellofemoral Arthritis by an Orthosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 52
- Primary Endpoint
- Evaluate improvement in function
Study Overview
Brief 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.
Detailed Description
All patients that sign the informed consent will be randomized and asked to participate in a 4-hour course about knee osteoarthritis. They will be sent home with a form to fill in all medications consumed daily for a month. They will return to the hospital where according to data given by www.randomization.com, they will receive one of two braces in one or both knees depending on their symptoms.
The functional brace has medial, lateral, superior and inferior "ruber bands" that should center patella in the patella groove. The other traditional neoprene sleeve brace with a patellar opening also tries to do the same with no other reinforcement other than the neoprene sleeve.
Prior to bracing, patients will deliver the prior month medication form, answer WOMAC and Lequesne questionnaires, and perform TUG, FTSST and the six-minute walk test.
They will be instructed to use the brace for 2 hours in the first day increasing half an hour per day up to a maximum of 12 hours/day. In case of difficulties with the brace for 12 continuous hours, they will be allowed to use it for at least 4 hours with a 2 hours interval and then again returning to bracing. Patients should sleep/rest without the brace(s). They should use their braces during physical activities unless if under water.
The primary objective is to evaluate and compare the short-term benefits of knee stabilization and compression. Therefore, the follow-up assessments, will be made prior to bracing and after one and three months. The evaluation will include the delivery of the registration of medications consumed daily (along with the hours of use of the orthosis), the WOMAC and Lequesne questionnaires and functional evaluations. X-rays without the braces (Front Schuss, profile and Axial) for measurement of affected joint spaces will be made before inclusion and after one year. Panoramic X-rays of the lower limbs will be performed before inclusion to measure the internal and external femoral-tibial angle. Complaints (pain, slip, swelling, skin lesions) and satisfaction (decrease pain, mobility improvement) with the use of the brace will be sought at each encounter. Patients will be asked about their weekly physical activity (intensity, type and hours of physical activity) on any adverse effects when using orthotics. Weight and height will be measured and each assessment to calculate BMI.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with symptomatic knee OA (patellofemoral)
Exclusion Criteria
- •Not using the brace as requested;
- •Study abandonment;
- •No adaptation to brace;
- •Skin and vascular complications by use of the brace;
- •Failure to complete the consumption of drugs between inclusion and bracing;
- •Obesity class II, III or morbid;
- •Patients who cannot read or understand the informed consent or the WOMAC questionnaire;
Outcomes
Primary Outcomes
Evaluate improvement in function
Time Frame: baseline and 3 months
Apply the Lequesne questionnaire
Secondary Outcomes
- Improvement in function with six minute walk test(baseline, 1 month, 3 months and 1 year)
- Improvement in pain(baseline, 1 month, 3 months and 1 year)
- Improvement in stiffness(baseline, 1 month, 3 months and 1 year)
- Improvement in function with the TUG (Timed-Up-and-Go)(baseline, 1 month, 3 months and 1 year)
- Improvement in function with Five-Times-Sit-To-Stand-Test (FTSST)(baseline, 1 month, 3 months and 1 year)
Investigators
Marcia Uchoa Rezende
MD; PhD
University of Sao Paulo General Hospital