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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: J L Marsh
• Collaborator: United States Department of Defense
• Treatments: Amobarbital; Hyaluronic Acid

Criteria

Inclusion Criteria:

• Age ≥ 18 and ≤ 60 years

• Acute closed or type 1 open pilon fractures without operative ipsilateral extremity trauma

• Fractures will be classified as OTA/AO 43 B 1-3 and 43 C 1- 3.

• Fractures must be eligible for a staged treatment protocol and be treated within 24 hours of injury. They must have a CT scan prior to definitive ORIF

Exclusion Criteria:

• Diabetes

• Allergic to poultry products (HA in GelOne® is derived from chickens).

• Previous injuries to the ankle

• Pre-existing immunologic or hematologic diseases

• High grade open wounds

• Pre-existing immunologic or hematologic diseases.

• High grade open wounds

• Pre-existing ankle arthritis

• Ipsilateral fractures

• Associated injuries that preclude standard rehabilitation

• Pre-existing dysfunction of the kidneys, liver, blood, immune system, endocrine system (excluding diabetes)

• Serum creatinine ≥ 1.4 mg/dl; BUN > 30 mg/dl ; ALT ≥ 60 IU/L in males and ≥ 50 IU/L in females; AST ≥ 45 IU/L in males and > 40 IU/L in females; platelets ≤ 50,000/μl; urinalysis