Efficacy Study of an Unloading Brace for Knee Osteoarthritis

Not Applicable

Completed

Conditions: Osteoarthritis of the Knee

Interventions: Device: Breg Fusion Unloading Brace

Registration Number: NCT02150057

Lead Sponsor: Andrews Research & Education Foundation

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 51

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Breg Fusion Unloading Brace	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.

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score	Baseline, 6 month follow-up	The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be administered to collect patient reported outcomes as they relate to pain, function, and quality of life. The pain scale range is 0-10 with lower scores indicating less pain.

Secondary Outcome Measures