Bracing for Patellofemoral Osteoarthritis
Condition: Knee Osteoarthritis; Metabolic Disease
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Metabolic Diseases
Study type: Interventional

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.
    

Intervention name(s): Womac; Lequesne; Timed-up-and-go (TUG); five-times-sit-to-stand-test (FTSST); Six-minute walk test.; functional patellofemoral neoprene brace; neoprene sleeve brace.
Intervention type(s): Device; Device; Device; Device; Device; Device; Device
Intervention description(s): Answer Womac questionnaires at baseline, 1 month, 3 months and 1 year; Answer Lequesne questionnaires at baseline, 1 month, 3 months and 1 year; Perform Timed-up-and-go (TUG) at baseline, 1 month, 3 months and 1 year; Perform the five-times-sit-to-stand-test (FTSST) at baseline, 1 month, 3 months and 1 year; Perform six-minute walk test at baseline, 3 months and 1 year; Use the functional patellofemoral neoprene brace for 2 hours/day minimum - 12 hours/day maximum; Use the neoprene sleeve brace for 2 hours/day minimum - 12 hours/day maximum
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: knee; knee osteoarthritis; Bracing; patellofemoral osteoarthritis