Trials / Recruiting
RecruitingNCT06555848
CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
A Post-Market Prospective Cohort Study on Subjects Receiving CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 128 (estimated)
- Sponsor
- BONESUPPORT AB · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.
Detailed description
The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure. The purpose of this post market prospective cohort study is to obtain longer-term clinical and radiographic data on the safety and effectiveness of CERAMENT G as part of the surgical treatment of Osteomyelitis in a single-stage procedure. Detailed questions to be answered are: 1. What is the nature, severity, and frequency of incomplete new bone formation? 2. What is the nature, severity, and frequency of the risks of probable adverse events and serious adverse events associated with incomplete new bone formation, including pathologic fractures and reinfection?
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CERAMENT G | CERAMENT G is intended for use as a bone void filler as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) as part of the surgical treatment of osteomyelitis. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing. |
Timeline
- Start date
- 2025-06-02
- Primary completion
- 2031-10-01
- Completion
- 2032-10-01
- First posted
- 2024-08-15
- Last updated
- 2025-10-03
Locations
1 site across 1 country: United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06555848. Inclusion in this directory is not an endorsement.