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

NCT06555848 | Recruiting FDA Device

• 1 other identifier: 339381
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteomyelitis

Outcome Measures

Primary Outcomes (2)

• Composite Endpoint

  Overall subject success requires all four of the following at 36 months post-op: * absence of a reinfection of the original site of osteomyelitis; * absence of purulent drainage and wound dehiscence/breakdown * absence of a secondary surgical intervention, e.g., grafting or removal of residual CERAMENT G at the original site; and, * a lack of serious adverse events associated with incomplete new bone formation, including pathologic fracture of the treated limb

  36 months

• Co-Primary Endpoint

  A trend showing increasing new bone formation and decreasing CERAMENT G as determined by a comparison of baseline and interim post-operative timepoint radiographic evaluations out to 36 months post-operative

  36 months

Secondary Outcomes (2)

• Radiographic Succcess

  36 months

• Clinical Success

  36 months

Study Arms (1)

CERAMENT G

Subjects receiving CERAMENT G as part of the surgical treatment of Osteomyelitis

Device: CERAMENT G

Interventions

CERAMENT G DEVICE

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.

CERAMENT G

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled post-operatively with Osteomyelitis

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• BONESUPPORT AB: lead

Study Sites (1)

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

Oxford, OX37HE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: June 2, 2025
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2032
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)