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Translating Metabolic Responses to Mechanical Insult Into Early Interventions to Prevent PTOA

NCT04589611 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-03-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

amobarbital/Gel-One (one dose)

One dose of amobarbital/Gel-One during the initial surgical intervention

DRUG

Placebo (single dose)

One dose of placebo during the initial surgical intervention

DRUG

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.

DRUG

Placebo (two doses)

One dose of placebo during the initial surgical intervention. A second dose will be administered during the second surgical intervention.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • J L Marsh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2023-12-01
Completion
2023-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04589611 on ClinicalTrials.gov