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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteomyelitis
• Intervention / Treatment: Device: CERAMENT G

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?

• Study Type: Observational
• Enrollment (Estimated): 128

Contacts and Locations

• Study Contact: Name: Kursheed Khan, MD; Phone Number: +447887372158; Email: kursheed.khan@bonesupport.com
• Study Contact Backup: Name: Michael Diefenbeck, MD; Phone Number: +49 173 575 0464; Email: michael.diefenbeck@bonesupport.com

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX37HE
    • Recruiting
    • Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHS
    • Contact: Jamie Ferguson, MD; Phone Number: +447482491449; Email: jamie.ferguson@ouh.nhs.uk
    • Principal Investigator: Jamie Ferguson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled post-operatively with Osteomyelitis

Description

Inclusion Criteria:

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

1. 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.

2. Symptoms for a minimum of six months with clinical and radiological features accompanied by at least one of the following:

   1. the presence of a sinus
   2. the presence of an abscess or intra-operative pus
   3. the presence of positive supportive histology
   4. 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:

1. 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)
2. Those unable to give informed consent for inclusion in the trial, or those not willing to be included
3. A known allergy or reaction to gentamicin or calcium sulfate
4. Treatment with a combination of different antibiotic-eluting bone graft substitutes
5. They have a segmental bone defect > 1cm
6. Infection of the spine

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Succcess	Radiographic success at 36 months, defined as CERAMENT G resorption and new bone formation (a minimum of mean void-filling of 74% in the subject population) as determined by comparison of the immediate post-op radiographs to those at 36 months	36 months
Clinical Success	Clinical success at 36 months, defined as: Maintenance or improvement in function (i.e., no decrease of PRO(s) in the SF-12 score between post-operative and 36 months follow-up)	36 months

Collaborators and Investigators

• Sponsor: BONESUPPORT AB

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2025
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2032

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Infections; Bone Diseases, Infectious; Osteomyelitis
• Other Study ID Numbers: 339381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No