Efficacy Study of an Unloading Brace for Knee Osteoarthritis

Andrews Research & Education Foundation

Status: Completed

Conditions: Osteoarthritis of the Knee

Treatments: Device: Breg Fusion Unloading Brace

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02150057

BREG72609

Details and patient eligibility

About

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.

Full 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

Enrollment: 51 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Control Group

No Intervention group

Description:

This group receives no experimental bracing intervention in the study.

Experimental Group

Active Comparator group

Description:

This group will receive the Breg Fusion Osteoarthritis Knee Unloading Brace to wear for a determined amount of time per study protocol for the treatment of osteoarthritis pain.

Treatment:

Device: Breg Fusion Unloading Brace