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Porous Titanium Microspheres in Kyphoplasty

NCT05815251 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2023-04-21

No results posted yet for this study

Summary

Study is a prospective observational, performed in the context of normal clinical practice, of patients with osteoporotic vertebral compression fractures identified as candidates for kyphoplasty treatment with porous trabecular titanium microspheres (see whether to put commercial name and company). The study does not involve any interference with the patient's diagnostic-therapeutic course The objective of the study is the clinical-radiological evaluation of the efficacy of kyphoplasty treatment with trabecular porous titanium spheres in terms of pain control and reduction of kyphotic deformity following fracture. Further evaluation of the safety of the treatment in terms of absence of intraoperative adverse events and material-related toxicity.

Conditions

  • Vertebral Fracture
  • Kyphoplasty

Sponsors & Collaborators

  • University of Roma La Sapienza

    collaborator OTHER

  • Unit of neurosurgery, Departement of Neurosciences, University of Torino

    lead OTHER

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05815251 on ClinicalTrials.gov