Efficacy Study of an Unloading Brace for Knee Osteoarthritis

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02150057
Study type	Interventional
Source	Andrews Research & Education Foundation
Contact
Status	Completed
Phase	N/A
Start date	February 2010
Completion date	May 2013

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.