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

History of Changes

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:

MedlinePlus related topics: Osteoarthritis Steroids

U.S. FDA Resources

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 (Adult, Senior)
Sexes Eligible for Study:	All
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


ClinicalTrials.gov Identifier:	NCT00312533 History of Changes
Other Study ID Numbers:	SHRF2006-01
Study First Received:	April 6, 2006
Last Updated:	August 22, 2008

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 Hylan Viscosupplements Protective Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017

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