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
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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.

Locations
Other Locations
United Kingdom
Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHS
RECRUITING
Oxford
Contact Information
Primary
Kursheed Khan, MD
kursheed.khan@bonesupport.com
+447887372158
Backup
Michael Diefenbeck, MD
michael.diefenbeck@bonesupport.com
+49 173 575 0464
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2032-10
Participants
Target number of participants: 128
Treatments
CERAMENT G
Subjects receiving CERAMENT G as part of the surgical treatment of Osteomyelitis
Related Therapeutic Areas
Sponsors
Leads: BONESUPPORT AB

This content was sourced from clinicaltrials.gov

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