Post-op Treatment With Hyaluronic Acid Injections

This study has been terminated.
(Insurance now covers post-operative HA injections, which drastically decreased the number of patients willing to participate in the study.)
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
The Hawkins Foundation
ClinicalTrials.gov Identifier:
NCT01256788
First received: December 6, 2010
Last updated: April 21, 2014
Last verified: April 2014
  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:


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


Enrollment: 33
Study Start Date: September 2010
Estimated Study Completion Date: April 2015
Primary Completion Date: April 2014 (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
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: 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

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: April 21, 2014
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 16, 2014