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Post-op Treatment With Hyaluronic Acid Injections

This study is currently recruiting participants.
Verified July 2011 by The Hawkins Foundation
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
The Hawkins Foundation
ClinicalTrials.gov Identifier:
NCT01256788
First received: December 6, 2010
Last updated: March 21, 2012
Last verified: July 2011
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hawkins Foundation:

Primary Outcome Measures:
  • Pain level associated with knee condition [ Time Frame: 1 yr postop ] [ Designated as safety issue: No ]
    Outcome measurement tools: Tegner, Lyshom, IKDC, SF-12, WOMET, WOMAC, GRoC, VAS

  • Functional level associated with knee condition [ Time Frame: 1 yr postop ] [ Designated as safety issue: No ]
    Outcome measurement tools: Tegner, Lyshom, IKDC, SF-12, WOMET, WOMAC, GRoC, VAS


Estimated Enrollment: 99
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256788

Contacts
Contact: Jennifer Mercuri, M.S. 864-454-7458 jennifer.mercuri@hawkinsfoundation.com

Locations
United States, South Carolina
Steadman Hawkins Clinic of the Carolinas Recruiting
Greenville, South Carolina, United States, 29615
Principal Investigator: Doug Wyland, MD            
Sub-Investigator: Paul Siffri, MD            
Sub-Investigator: Stephen Geary, MD            
Sub-Investigator: Jason Folk, MD            
Sponsors and Collaborators
The Hawkins Foundation
Ferring Pharmaceuticals
Investigators
Study Chair: Thomas Pace, MD Greenville Hospital System
  More Information

No publications provided

Responsible Party: The Hawkins Foundation
ClinicalTrials.gov Identifier: NCT01256788     History of Changes
Other Study ID Numbers: Pro00007133
Study First Received: December 6, 2010
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013