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Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures

NCT06670404 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2025-02-17

No results posted yet for this study

Summary

The purpose of this study is to collect clinical and radiographic outcomes in patients undergoing vertebroplasty procedures for the treatment of osteoporotic or pathological fractures of the vertebral body to understand the role of sagittal balance in patient outcomes. To support this objective, the sagittal balance measurement of sagittal vertical axis (SVA), NRS back pain, Quebec Back Pain Disability Scale (Quebec) score, and complications will be collected. The secondary purpose of the study is to review the role of sagittal balance and adjacent facet joint arthropathy treatment in patients with vertebral body fractures due to osteoporosis or tumor.

Conditions

  • Vertebral Compression Fractures
  • Pathological Fracture
  • Facet Joint Arthropathy

Interventions

DEVICE

Vertebroplasty

Vertebral compression fractures treated with CONFIDENCE High Viscosity Cement

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

  • Dr Danoob Dalili

    collaborator UNKNOWN

  • Prof Nicolas Theumann

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-06
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Companies

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 NCT06670404 on ClinicalTrials.gov