Efficacy Study of an Unloading Brace for Knee Osteoarthritis

October 2, 2019 updated by: Andrews Research & Education Foundation

Efficacy of Medial Compartment Unloading Brace Use for Osteoarthritis of the the Knee: A Prospective Randomized Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Andrews Institute for Orthopaedics & Sports Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
This group receives no experimental bracing intervention in the study.
Active Comparator: Experimental Group
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.
Device: Breg Fusion Unloading Brace
This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.
Other Names:
  • Breg Fusion Osteoarthritis Knee Unloading Brace

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score
Time Frame: 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.
Baseline, 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrews Research & Education Foundation

Collaborators

BREG, Inc

Investigators

  • Principal Investigator: Roger Ostrander, MD, Andrews Institute for Orthopaedics & Sports Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Actual)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BREG72609

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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