drugset / Trial / NCT04201743
An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft injection for the treatment of knee osteoarthritis and to confirm whether the use of 2 mL of the same amniotic injection offers a statistically significant advantage over the 1 mL injection.
Timeline
- Start
- 2020-03-30
- Primary completion
- 2021-06
- Completion
- 2021-12
Outcome
Outcome not reported
Stopped: “Resources limited secondary to COVID-19 pandemic.”
Publications
- Background Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications. Am J Sports Med. 2016 Sep;44(9):2425-34. doi: 10.1177/0363546515612750. Epub 2015 Nov 19.
- Background Vines JB, Aliprantis AO, Gomoll AH, Farr J. Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. J Knee Surg. 2016 Aug;29(6):443-50. doi: 10.1055/s-0035-1569481. Epub 2015 Dec 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | NuDYN | Other / unclassified | 1 ml | Other |
| Comparator | NuDYN | Other / unclassified | 2 ml | Other |