Efficacy Study of an Unloading Brace for Knee Osteoarthritis
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Subjects with symptomatic unicompartmental osteoarthritis of the knee will be invited to
      participate in this randomized study. Subjects will be assigned to either a Fusion
      Osteoarthritis Knee Brace group, or a control group that does not wear a brace. It is
      hypothesized that use of the Fusion Osteoarthritis Knee Brace will have a better outcome on
      osteoarthritis knee pain and quality of life compared to those who do not receive bracing
      intervention.
    

Detailed description: 
      This investigation will recruit 72 subjects from the clinical population of the investigators
      with symptomatic unicompartmental osteoarthritis of the medial compartment of the knee who
      meet the inclusion criteria of the investigation. Subjects who meet the recruitment
      conditions will be prospectively randomized into one of two treatment groups for 6 month
      evaluation:

        1. Fusion Osteoarthritis Knee Brace

        2. No brace group

      Inclusion Criteria:

        -  Age 30-80.

        -  History of medial unicompartmental knee pain > 3 months duration (medial compartment
           only).

        -  Narrowing of medial joint space < one half of lateral compartment

        -  Varus deformity no greater than 80

        -  Mild to moderate limitation in Activities of Daily Living (ADL's) and/or recreational
           activities.

        -  Must read and understand English language and demonstrate the ability and willingness to
           follow the protocol and complete the questionnaires and diaries.

        -  Manual dexterity sufficient to perform all tasks required of study participants.

        -  Willingness to wear the brace a minimum of 4 hours per day.

      Exclusion Criteria:

        -  Arthritides other than osteoarthritis.

        -  Previous high tibial osteotomy of the affected knee.

        -  Previous surgery of affected knee other than diagnostic arthroscopy with joint
           debridement, soft tissue reconstruction, menisectomy.

        -  Fixed flexion deformities / limitations >10 degrees as compared to the contralateral
           limb.

        -  Flexion limitation > 20 degrees.

        -  Significant soft tissue compromise preventing long-term brace use.

        -  Peripheral vascular disease or other neurovascular complaints
    

Intervention name(s): Breg Fusion Unloading Brace
Intervention type(s): Device
Intervention description(s): This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.
Other intervention name(s): Breg Fusion Osteoarthritis Knee Unloading Brace
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects who meet the recruitment conditions will be prospectively randomized into one of two treatment groups for 6 month evaluation:
Breg Fusion Osteoarthritis Knee Brace
No brace group Both groups will be allowed to continue standard conservative treatment of osteoarthritis including anti-inflammatory medications, home exercises and joint supplements.
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: knee osteoarthritis unicompartmental unloading brace