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Long-Term Management of "Younger, Active" Patients With Pain From Early Knee Osteoarthritis With Synvisc-One (Hylan G-F 20) (SYNVISC-ONE)
This study aims to study use of viscosupplementation as a treatment of pain for young individuals who are active. Typically viscosupplementation is considered an intervention for knee osteoarthritis often for older patients who are less active. Many young active patients can also develop knee osteoarthritis after trauma or surgery or for congenital reasons. Treatment of these patients commonly are steroid injections which have more biologically detrimental effects for cartilage compared to viscosupplementation Synvisc One injections which are a single injection will be used to determine effectiveness of reducing pain and maintaining an active healthy lifestyle for younger patients aged 30-50 years old.
Details
| Lead sponsor | Anthony Luke |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 51 |
| Start date | 2011-11 |
| Completion | 2019-08-07 |
Conditions
- Osteoarthritis
Interventions
- Synvisc-One (G-F 20)
Primary outcomes
- "Worst Knee Pain" Likert Scale (0-10) Reported on Survey — 26 weeks after injection at baseline
Worst Knee Pain Scores were measured using a "Worst Knee Pain" Likert scale, the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain. Patient Acceptable Symptom State (PASS) is a "Worst Knee Pain" reported score of less than 4 to be "positive". Patient Acceptable Symptom State (PASS) is the highest level of symptom beyond which patients consider themselves well. Minimum Clinical Important Improvement (MCII) is improvement at any time in the 26 week time frame that "Worst Knee Pain" is reported at 2 points less than baseline.
Countries
United States