NCT06628115

Post Market Study of Cerament V/G in Pedal Osteomyelitis

Post-market Study of Cerament V/G in Foot Osteomyelitis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Mid and South Essex NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to look at the outcomes of patients who have had bone infection of their feet treated with a licensed antibiotic paste. The main question it aims to answer is: • How does the bone infection heal in response to the antibiotic paste? Participants will: * Undergo standard surgery to remove dead bone and drain any pus. * Antibiotic paste is injected directly into the middle of the bone at surgery. This is instead of receiving antibiotics directly into their bloodstream for 6 weeks. * Recieve one week of tablet antibiotics. * Visit clinic 1 month after surgery for a normal clinical appointment. After, a research team member will ask the participant a few questions. The participant will also have a foot x-ray, wound photograph and fill out a short questionnaire. * Visit clinic 6 months and 12 months following the surgery. A research team member will ask the participant a few questions. The participant will also have a foot x-ray, wound photograph and fill out a short questionnaire.

Conditions

• Osteomyelitis - Foot

Interventions

Type	Name	Description
DEVICE	cerament V or G	Cerament V or G implantation into forefoot or mid foot bone, and 7-10 days of oral antibiotics.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2024-10-04
• Last updated: 2024-10-04