Translating Metabolic Responses to Mechanical Insult Into Early Interventions to Prevent PTOA
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
This is a small-scale proof-of concept clinical trial of amobarbital as a treatment to
prevent post-traumatic osteoarthritis in fractured ankle joints. The study is a double blind,
prospective, randomized, placebo-controlled, stepwise trial. Amobarbital will be delivered to
ankle joints in solution with hyaluronic acid (HA) as a vehicle. Amobarbital/HA injections
(active dose) will be compared to HA alone (placebo dose). Our primary goal is to confirm
safety, but we will also assess whether treatment improves chondrocyte viability and
decreases synovial inflammation. The intervention that has proven to be effective in vitro
and in vivo models. The study team will assess safety and begin to evaluate efficacy of
amobarbital/Gel-One in patients having sustained tibial pilon fractures. The study team will
use advanced imaging-based methods we have developed to characterize how joints subjected to
varying levels of fracture severity and residual elevated contact stress respond in treated
and control groups.