CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure

Official title

A Post-Market Prospective Cohort Study on Subjects Receiving CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure

Overview

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?

Interventions

• 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.

Primary outcome measures

• Composite Endpoint [Time frame: 36 months]
• Co-Primary Endpoint [Time frame: 36 months]

Secondary outcome measures (2)

• Radiographic Succcess [Time frame: 36 months]
• Clinical Success [Time frame: 36 months]

Eligibility criteria

Inclusion criteria

Subjects meeting the following inclusion criteria are to be included in the analysis:

• Patients receiving CERAMENT G subsequent to surgical excision of osteomyelitis, with Cierny-Mader classification grades III or IV, who require dead-space management of a bone defect following surgical debridement and excision of infection.
• Symptoms for a minimum of six months with clinical and radiological features accompanied by at least one of the following:

• the presence of a sinus
• the presence of an abscess or intra-operative pus
• the presence of positive supportive histology
• two or more microbiological cultures with indistinguishable organisms (defined as cultures resulting in identification of the same microbe (e.g., Staph aureus) with similar antimicrobial sensitivity) Notes: In cases where cultures are negative, a patient will be included in the study only if there is positive supportive histology combined with the presence of a draining sinus or intra-operative pus. Infected non-unions will be included only if the bone loss is < 1cm after debridement and excision of bone has been performed.

Exclusion criteria

The subject will be excluded from the study if:

• Skeletal immaturity, defined as pre-operative/ screening radiology with evidence of incompletely fused physes. (determined by their previous x-rays which are taken as part of their admission, unrelated to the study)
• Those unable to give informed consent for inclusion in the trial, or those not willing to be included
• A known allergy or reaction to gentamicin or calcium sulfate
• Treatment with a combination of different antibiotic-eluting bone graft substitutes
• They have a segmental bone defect > 1cm
• Infection of the spine

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United Kingdom · 1 center

• Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHS — Oxford

Identifiers

NCT: NCT06555848 · 339381

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗