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

This study has been terminated.
(The study was terminated due to poor enrollment)
Sponsor:
Information provided by (Responsible Party):
OAD Orthopaedics
ClinicalTrials.gov Identifier:
NCT01478386
First received: November 21, 2011
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Knee Osteoarthritis
Other: Orthovisc
Device: DonJoy HA lite knee brace
Device: Orthovisc injections and DonJoy HA lite knee brace

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trail to Assess the Effectiveness of an Off-Loading Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by OAD Orthopaedics:

Primary Outcome Measures:
  • Reduction in knee pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 11
Study Start Date: December 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478386

Locations
United States, Illinois
OAD Orthopaedics
Warrenville, Illinois, United States, 60555
Sponsors and Collaborators
OAD Orthopaedics
Investigators
Principal Investigator: William R Sterba, MD OAD Orthopaedics
  More Information

Additional Information:
No publications provided

Responsible Party: OAD Orthopaedics
ClinicalTrials.gov Identifier: NCT01478386     History of Changes
Other Study ID Numbers: Knee OA Treatments
Study First Received: November 21, 2011
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Viscosupplements

ClinicalTrials.gov processed this record on October 23, 2014