Clinical trial NCT02984254: Bracing for Patellofemoral Osteoarthritis
Official title: Bracing for Patellofemoral Osteoarthritis. A Prospective Randomized Study of the Treatment of Patellofemoral Arthritis by an Orthosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Metabolic Disease
Keywords: knee
knee osteoarthritis
Bracing
patellofemoral osteoarthritis
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

The secondary objective is the improvement in pain, stiffness and long-term function (1 year). Therefore, after a brief analysis of the results of three months, if there is a clinically significant difference between the groups, all patients will use the brace with best results. Therefore the study will be a case series. If both groups show clinically relevant improvements with no significant differences between the orthotics, the study will remain with two arms and the same clinical assessments, questionnaires, functional and radiographic one year. If none of the groups show a clinically relevant improvement in three months, the study will be terminated. Adverse effects of the use of orthotics will also be recorded in the one-year visit. All patients will be advised to discontinue use of the braces and telephone to our secretary in case of any adverse effects in the period between the official evaluations for proper conduct.

Eligibility criteria: 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;

Primary outcomes:
measure: Evaluate improvement in function
timeFrame: baseline and 3 months
Secondary outcomes:
measure: Improvement in pain
timeFrame: baseline, 1 month, 3 months and 1 year
measure: Improvement in stiffness
timeFrame: baseline, 1 month, 3 months and 1 year
measure: Improvement in function with the TUG (Timed-Up-and-Go)
timeFrame: baseline, 1 month, 3 months and 1 year
measure: Improvement in function with Five-Times-Sit-To-Stand-Test (FTSST)
timeFrame: baseline, 1 month, 3 months and 1 year
measure: Improvement in function with six minute walk test
timeFrame: baseline, 1 month, 3 months and 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Department of Orthopedics and Traumatology - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
name: Marcia U Rezende, MD; PhD
role: PRINCIPAL_INVESTIGATOR
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