Effectiveness of a Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis

July 22, 2013 updated by: OAD Orthopaedics

Randomized Trail to Assess the Effectiveness of an Off-Loading Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis

Hypothesis: Viscosupplementation when combined with an off-loading knee brace is more effective in treating the symptoms of knee OA then treating with viscosupplementation alone

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

A randomized prospective study to assess the effectiveness of treating knee osteoarthritis with either a series of three viscosupplementation injections, an off-loading knee brace, or a combination of viscosupplementation and an off-loading knee brace. The viscosupplementation and off-loading knee brace are being used in accordance with their FDA approval. Subjects will be randomized to 1 of 3 treatment groups. The control group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections. The second group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections and an off loading knee brace. The third group will use the off loading knee brace alone. Subjects will complete the WOMAC Osteoarthritis Questionnaire (pain, stiffness, function) and VAS pain scale (measuring pain on movement) at baseline, day 7, day 14, 6 weeks and 3 months. Subjects in group 2 and 3 will be given a brace diary to record compliance.

Study Type

Interventional

Enrollment (Actual)

11

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
    • Illinois
      • Warrenville, Illinois, United States, 60555
        • OAD Orthopaedics

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Subjects, over the age of 18, with a diagnosis of knee osteoarthritis which is confirmed by radiographs.
  • Radiographs will be obtained and patients with mild to moderate knee osteoarthritis will qualify a subject for enrollment.
  • Subjects will also have a documented varus deformity.

Exclusion criteria:

  • Subjects with severe arthritis as demonstrated by radiographs.
  • In addition those subjects with a known or suspected joint infection and subjects who had undergone arthrocentesis and/or intra-articular injection within 3 months of the study will be excluded.
  • Female patients who are pregnant or breast feeding will also be excluded.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Viscosupplementation injections
Control group will receive a series of three viscosupplementation injections into the affected knee
Other: Orthovisc
Subjects will receive a series of three Orthovisc injections into their affected knee
Experimental: Off-loading knee brace
Device: DonJoy HA lite knee brace
Subjects will be fitted and educated on using the DonJoy HA lite knee brace to treat their affected knee
Experimental: Viscosupplementation and knee brace
Device: Orthovisc injections and DonJoy HA lite knee brace
Subjects will receive a series of three Orthovisc injections and be fitted and educated on using a DonJoy HA lite knee brace

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in knee pain
Time Frame: 3 months
The primary outcome measure will be a reduction in knee pain as measured by the VAS pain score. The secondary outcome measure will be an increase in function as measured by the WOMAC Osteoarthritis Questionnaire.
3 months

Collaborators and Investigators

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

Sponsor

OAD Orthopaedics

Investigators

  • Principal Investigator: William R Sterba, MD, OAD Orthopaedics

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.

Helpful Links

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

December 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

November 21, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (Estimate)

November 23, 2011

Study Record Updates

Last Update Posted (Estimate)

July 23, 2013

Last Update Submitted That Met QC Criteria

July 22, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Knee OA Treatments

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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