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Post-op Treatment With Hyaluronic Acid Injections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01256788
Recruitment Status : Terminated (Insurance now covers post-op HA injections, drastically decreasing enrollment.)
First Posted : December 9, 2010
Last Update Posted : July 24, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

This study will look at patients with post-operative treatment of a meniscal tear or degenerative joint disease (degenerative arthritis). They will be randomized into one of three groups: Euflexxa injection, saline (placebo) injection, or no injection. Those who are randomized into the injection group will receive a series of three injections (one a week for 3 weeks), then a "booster" injection at 6 months post-op. Several questionnaires will be given after the first set of injections, then again at a one year follow-up.

The hypothesis is that patients receiving hyaluronic acid injections will have better pain and function scores as compared with placebo and no further treatment at all time points.


Condition or disease Intervention/treatment Phase
Meniscus Tear Chondropathy/Degenerative Joint Disease (DJD) Device: Euflexxa Other: Saline Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study Evaluating Clinical Effectiveness of Post-op Treatment With Hyaluronic Acid Injections in Degenerative Joint Disease & Meniscal Tears
Study Start Date : September 2010
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Viscosupplementation
Hyaluronic acid injection
Device: Euflexxa
4 injections of 2ml of Euflexxa
Placebo Comparator: Saline injection Other: Saline
4 injections of 3 ml of sterile saline


Outcome Measures

Primary Outcome Measures :
  1. Pain level associated with knee condition [ Time Frame: 1 yr postop ]
    Outcome measurement tools: Tegner, Lyshom, IKDC, SF-12, WOMET, WOMAC, GRoC, VAS

  2. Functional level associated with knee condition [ Time Frame: 1 yr postop ]
    Outcome measurement tools: Tegner, Lyshom, IKDC, SF-12, WOMET, WOMAC, GRoC, VAS


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in post-op stage of treatment for meniscal tears or chondropathy/DJD
  • Over 40 years of age
  • A daily knee pain above 20mm on a 100mm visual analogue scale

Exclusion Criteria:

  • Previous recipient of viscosupplementation injections
  • Had rheumatoid arthritis or other inflammatory arthritis
  • Had intra-articular steroid injections within the previous 2 months
  • Invasive knee procedures within the past 6 months
  • Contraindications to hyaluronate (an allergy)
  • Medications that could interfere with the planned interventions
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256788


Locations
United States, South Carolina
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
The Hawkins Foundation
Ferring Pharmaceuticals
Investigators
Study Chair: Thomas Pace, MD Greenville Hospital System
More Information

Responsible Party: The Hawkins Foundation
ClinicalTrials.gov Identifier: NCT01256788     History of Changes
Other Study ID Numbers: Pro00007133
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015

Keywords provided by The Hawkins Foundation:
viscosupplementation
meniscus tear
degenerative joint disease

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