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Translating Metabolic Responses to Mechanical Insult Into Early Interventions to Prevent PTOA
Sponsor: J L Marsh
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 will be utilized has proven to be effective using 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.
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2022-07-20
Completion Date
2025-05-01
Last Updated
2026-07-06
Healthy Volunteers
No
Interventions
amobarbital/Gel-One (one dose)
One dose of amobarbital/Gel-One during the initial surgical intervention
Placebo (single dose)
One dose of placebo during the initial surgical intervention
amobarbital/Gel-One (two doses)
One dose of amobarbital/Gel-One during the initial surgical intervention. A second dose will be administered during the second surgical intervention.
Placebo (two doses)
One dose of placebo during the initial surgical intervention. A second dose will be administered during the second surgical intervention.
Locations (1)
University of Iowa
Iowa City, Iowa, United States