Osteoarthritis, Knee Clinical Trial
Official title:
A Pilot Study of a Dexamethasone Implant System in Humans
The purpose of this study is to determine whether a longer duration, controlled, sustained release dexamethasone delivery system would be more effective in helping patients with osteoarthritis reduce their pain, remain functional, and delay their need for knee replacement.
The objectives of the study are to assess the dexamethasone delivery system for:
- Safety and tolerability
- Efficacy
Formal statistical analysis to compare treatment groups will not be performed due to the
small number of participants in this pilot study. Summary statistics will be assessed using
the short form of the knee injury and osteoarthritis outcome score (KOOS JR) surveys and
questionnaires to assess pain intensity, pain medication consumption and wound assessment.
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