Clinical trial NCT02150057: Efficacy Study of an Unloading Brace for Knee Osteoarthritis
Official title: Efficacy of Medial Compartment Unloading Brace Use for Osteoarthritis of the the Knee: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Keywords: knee osteoarthritis unicompartmental unloading brace
Lead sponsor: Andrews Research & Education Foundation
Sponsor class: OTHER
Collaborators: name: BREG, Inc
First posted: 2014-05-29
Enrollment: 51
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects who meet the recruitment conditions will be prospectively randomized into one of two treatment groups for 6 month evaluation:

1. Breg Fusion Osteoarthritis Knee Brace
2. No brace group Both groups will be allowed to continue standard conservative treatment of osteoarthritis including anti-inflammatory medications, home exercises and joint supplements.
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: 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.
* Leg-length discrepancy \> 2cm.

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score
timeFrame: Baseline, 6 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Gulf Breeze
country: United States
facility: Andrews Institute for Orthopaedics & Sports Medicine
state: Florida
Study officials:
affiliation: Andrews Institute for Orthopaedics & Sports Medicine
name: Roger Ostrander, MD
role: PRINCIPAL_INVESTIGATOR
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