Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT05676905

Prospective Multicenter Observational Study on the Use of NEOCEMENT® for the Treatment of Bone Defects

Conditions: Bone Deformity

Sex: All
Ages: 18 Years – N/A
Enrollment: 165
Sponsor: Bioceramed

Summary

Neocement is a CE marked device, registered in INFARMED (Portuguese National Competent Authority) and Department of Planning and Organisation of the National Health Service - General board of Medical Devices, pharmaceutical services, and safety in healthcare (Italy). This protocol does not include any new intended uses, new populations, new materials or design changes.

Eligibility Criteria

Inclusion Criteria:Patients with bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of Neocement® / Neocement® Inject P.Age ≥ 18 years of both genders (male and female)Patient signed informed consent form (for data collection)Bone defects surgically created or osseous defects created from traumatic injury to the boneBone skeletal defects that are not intrinsic to the stability of bone structure OR site which can be stabilizedExclusion Criteria:Acute or chronic infection at the surgical site;Metabolic bone diseases;Severe degenerative disease conditions in which general bone grafting is not advisable;Active malignancy.Inability to understand consent and objectives of the study;Pregnant women or breastfeeding women;Unable to undergo medical monitoring for geographical, social or psychological reasons.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05676905). StuddyBuddy aggregates publicly available trial information.