Synvisc-One for Younger, Active Patients With Osteoarthritis (SYNVISC-ONE)
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|ClinicalTrials.gov Identifier: NCT01625013|
Recruitment Status : Unknown
Verified August 2014 by University of California, San Francisco.
Recruitment status was: Recruiting
First Posted : June 21, 2012
Last Update Posted : August 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Device: Synvisc-One (G-F 20)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-Term Management of "Younger, Active" Patients With Pain From Early Knee Osteoarthritis With Synvisc-One (Hylan G-F 20)|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2015|
Device: Synvisc-One (G-F 20)
Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.
- Decreased pain [ Time Frame: 26 weeks post-injection through 3 years post-injection ]To identify whether injection of 6 mL hylan G-F 20 decreases pain over 26 weeks in young (ages 30 to 50 years) active patients with symptomatic primary osteoarthritis of the knee not treated previously with hylan G-F 20.
- The effect of repeated treatments [ Time Frame: 26 weeks post-injection through 3 years post-injection ]Though symptoms can be improved for periods up to 6 months, pain symptoms can recur. The effect of repeated treatments of hylan G-F 20 will be studied.
- Identify the effects of treatment on activity levels [ Time Frame: 26 weeks post-injection through 3 years post-injection ]To identify the effects of treatment with hylan G-F 20 on activity levels (using objective activity measures utilizing accelerometer and Physical Activity Enjoyment Scale (PACES) and quality of life scores (WOMAC, SF-12) comparing baseline to treatment at 3 months.
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): NCT01625013
|Contact: Caroline Currie, MA||415 353 7987||Curriec@orthosurg.ucsf.org|
|Contact: Anthony Luke, MD||415-885-3807||LukeA@orthosurg.ucsf.edu|
|United States, California|
|University of California||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Caroline Currie 415-353-7987 CurrieC@orthosurg.ucsf.edu|
|Contact: Catherine Cook 415-514-6120 email@example.com|
|Principal Investigator:||Anthony Luke, MD||University of California, San Francisco|