Outcome Following Hylan F- 20 (Synvisc) + Corticosteroid Injections for the Treatment of Osteoarthritis of the Knee
![]() |
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: NCT00312533 |
Recruitment Status
:
Completed
First Posted
: April 10, 2006
Last Update Posted
: August 25, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Osteoarthritis, Knee | Drug: Hylan F- 20 |
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.
Study Type : | Observational |
Estimated Enrollment : | 60 participants |
Time Perspective: | Prospective |
Official Title: | Outcome Following Hylan F- 20 (Synvisc) + Corticosteroid Injections for the Treatment of Osteoarthritis of the Knee |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |


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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT00312533
United States, Colorado | |
Steadman Hawkins Clinic | |
Vail, Colorado, United States, 81657 |
Principal Investigator: | John R Steadman, MD | Steadman Hawkins Research Foundation |
ClinicalTrials.gov Identifier: | NCT00312533 History of Changes |
Other Study ID Numbers: |
SHRF2006-01 |
First Posted: | April 10, 2006 Key Record Dates |
Last Update Posted: | August 25, 2008 |
Last Verified: | August 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 |