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Bone Substitutes Outcomes - Post Market Follow-up

NCT06374342 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 425

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 Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels.

TEKNIMED bone substitutes are legacy products, some marketed for more than 20 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

  • Bone Resorption

Interventions

DEVICE

Bone defect

Bone grafting is a procedure where damaged bones can be repaired or rebuilt using transplanted bone from another source. Sources for transplant bone include the patient (autograft), a cadaver (allograft) or synthetic bone.

DEVICE

Spine fusion

Spinal fusion is a surgery procedure that reinforces your back structure and stability by linking two vertebrae together

DEVICE

Cage filling

Intervertebral fusion with cages is a surgical procedure used to stabilize the spine by fusing adjacent vertebrae. The cages, typically made of materials like titanium or plastic, and pre-filled with bone graft substitutes are placed between the vertebrae to maintain the proper spacing and alignment.

Sponsors & Collaborators

  • Teknimed

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2026-09-16
Completion
2032-09-30

Countries

  • France
  • Germany

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 NCT06374342 on ClinicalTrials.gov