Status:

RECRUITING

Bone Substitutes Outcomes - Post Market Follow-up

Lead Sponsor:

Teknimed

Conditions:

Bone Resorption

Eligibility:

All Genders

18+ years

Brief 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 lab...

Detailed Description

It is admitted that: * Surgeons are often concerned by bone void filling and they can choose between synthetic bone substitutes or bone grafts of animal or human origin. * Due to their chemical compo...

Eligibility Criteria

Inclusion Criteria:

  • Be 18 years or older.

  • Be willing to sign an informed consent approved by IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France) and

    o For prospective inclusion:

  • Be considered for a surgery where bone filling with one of the TEKNIMED bone substitutes comprised in this study is needed and intended to be used according to the IFU.

    o For retrospective inclusion:

  • Have undergone a surgery with a TEKNIMED bone substitute used according to the IFU, between the 1st January 2015 and the date of the site initiation visit

  • Be informed of the study and not being opposed to the use of their clinical data in the study (France) or be willing to sign an informed consent (where applicable) during the first follow-up visit following the site initiation.

Exclusion Criteria:

Patients presenting one of the following conditions will not be included:

  • Under trusteeship or guardianship
  • Pregnancy or breast-feeding women

According to contraindications per IFU:

  • Procedures other than those stated in the INDICATIONS section
  • Patients susceptible to allergic reactions to the product components.

CERAFORM®, TRIHA+®:

- Treatment of large bone defects which could impact the stability of bone structure without implementing a mechanical stabilisation system (such as plate(s), screw(s), nail(s), cage(s))

NANOGEL®:

  • Use in vertebroplasty procedures
  • Subcutaneous use

Key Trial Info

Start Date :

September 16 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 30 2032

Estimated Enrollment :

425 Patients enrolled

Trial Details

Trial ID

NCT06374342

Start Date

September 16 2021

End Date

September 30 2032

Last Update

September 9 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Pôle Rachis Hôpital Privé d'Eure et Loir

Mainvilliers, Eure et Loir, France, 28300

2

Hôpital Joseph Ducuing

Toulouse, Haute Garonne, France, 31000

3

Clinique Médipole Garonne

Toulouse, Haute Garonne, France, 31100

4

CHRU Brabois

Nancy, Meurthe et Moselle, France, 54000