Outcome Following Hylan F- 20 (Synvisc) + Corticosteroid Injections for the Treatment of Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Steadman Hawkins Research Foundation
ClinicalTrials.gov Identifier:
NCT00312533
First received: April 6, 2006
Last updated: August 22, 2008
Last verified: August 2008
  Purpose

The goal of viscosupplementation is to replenish synovial fluid, which will improve patient symptoms and mobility. Viscosupplementation of the knee with hyaluronic acid injections has been shown to improve symptoms in patients with osteoarthritis. Recent studies have shown that this improvement may be highly variable based on the time from treatment, especially in the first 12 weeks following treatment. The purpose of this study is to document the outcomes following a treatment protocol in which corticosteroid is used in addition to the initial Synvisc injection in the series of three injections.


Condition Intervention
Osteoarthritis, Knee
Drug: Hylan F- 20

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Outcome Following Hylan F- 20 (Synvisc) + Corticosteroid Injections for the Treatment of Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by Steadman Hawkins Research Foundation:

Estimated Enrollment: 60
Study Start Date: April 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Upon initial visit, all study patients will complete an informed consent. After consent, patients will complete the baseline questionnaire packet, which includes a questionnaire with several validated scoring systems. Following injection, patients will receive a diary to document any adverse events between the first and second injection. In one week, patients will return for a second visit to receive the second injection. Again they will be asked to maintain their diary of adverse events following the second injection. The patient will then receive the final injection at week 3 and will again complete a diary of events for one week. At 1 week, 3 weeks, 6 weeks, 12 weeks, and 26 weeks following the completed series of injections, the patients will complete a form that will include the pain, stiffness, and physical function subscales of the WOMAC score and a 10 point patient satisfaction question.

At 6 months, the patients will receive by mail the same questionnaire packet they received at baseline, with the addition of patient satisfaction and subsequent injury/treatment questions.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women aged 18 to 80 years
  • with a diagnosis of osteoarthritis of the knee. Diagnosis will be based on radiographic examination (Kellgren-Lawrence 2 or 3) or by previous arthroscopic diagnosis.

Surgical treatment for osteoarthritis will be limited to arthroscopic surgeries that include removal of loose bodies, resection of unstable meniscus tears and loose or unstable chondral flaps, removal of osteophytes if they limit extension, and lysis of adhesions. These types of treatments may provide symptomatic relief by increasing joint volume in knees with osteoarthritis and relieving joint contact pressures.

Exclusion Criteria:

  • Patients with grade 4 Kellgren-Lawrence on radiographic examination will be excluded.
  • Patients with a prior synovectomy on knee to be injected will be excluded.
  • Patients will be excluded if they have rheumatoid disease or any other serious systemic disease, acute synovitis or excessive effusion, allergy to avian products/hyaluronan-based injection components/corticosteroid injection, pregnant, previous arthroscopic surgery within the last 6 months or had a joint infection within the previous 3 months.
  • Patients who have undergone a prior synovectomy will not be included.
  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: NCT00312533

Locations
United States, Colorado
Steadman Hawkins Clinic
Vail, Colorado, United States, 81657
Sponsors and Collaborators
Steadman Hawkins Research Foundation
Genzyme, a Sanofi Company
Investigators
Principal Investigator: John R Steadman, MD Steadman Hawkins Research Foundation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00312533     History of Changes
Other Study ID Numbers: SHRF2006-01
Study First Received: April 6, 2006
Last Updated: August 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Steadman Hawkins Research Foundation:
knee
injection
function
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014