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Spine Bone Cements Outcomes - Post Market Follow-up

NCT06367582 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-09-09

No results posted yet for this study

Summary

A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels.

TEKNIMED bone cements are legacy products, some marketed for more than 10 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting.

The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites.

Conditions

  • Vertebral Fracture
  • Compression Fracture
  • Osteoporotic Fractures

Interventions

DEVICE

Vertebroplasty (VP)

Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain

DEVICE

Kyphoplasty (KP)

Kyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain

DEVICE

Pedicular Screw Augmentation (PSA)

Pedicular Screw Augmentation is a procedure in which a special medical-grade cement mixture is injected into pedicular screws in order to augment fixation strength

Sponsors & Collaborators

  • Teknimed

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-04
Primary Completion
2029-09-04
Completion
2039-09-30

Countries

  • France
  • Portugal
  • Spain
  • Ukraine

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 NCT06367582 on ClinicalTrials.gov