ClinicaliQ Trial Snapshot
- CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure — Recruiting • Infectious Disease • NCT06555848.
- What is being tested: CERAMENT G (an antibiotic-loaded bone void filler) is being evaluated as part of single-stage surgical treatment for osteomyelitis, combining debridement and reconstruction in one procedure rather than traditional two-stage approaches.
- Patient eligibility overview: The study includes subjects undergoing single-stage surgical treatment for osteomyelitis where CERAMENT G was used as an adjunct to standard surgical debridement and management.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.