Efficacy Study of an Unloading Brace for Knee Osteoarthritis

Completed · Not applicable

Conditions studied: Osteoarthritis of the Knee

In brief

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.

Key facts

Study ID

NCT02150057

Run by

Andrews Research & Education Foundation

People needed

51

Starts

2010-02-01

Expected to finish

2013-05-01

Last updated by the study team

2019-10-22

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Andrews Institute for Orthopaedics & Sports Medicine — Gulf Breeze, Florida, United States

Full record on ClinicalTrials.gov

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