Collecting data on the safety and performance of TEKNIMED bone substitutes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather clinical data on the safety and performance of TEKNIMED's range of bone substitutes, including CERAFORM, TRIHA+, and NANOGEL. It involves both retrospective and prospective data collection from patients who have undergone surgeries requiring these products. The study will follow patients according to local standard medical care, assessing the effectiveness of these synthetic alternatives to traditional bone grafts. The goal is to confirm the safety and efficacy of these products in real-life clinical settings.

Why it matters

Who can join: the full rules

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

Where it's running

• Pôle Rachis Hôpital Privé d'Eure et Loir
  Mainvilliers, Eure et Loir, France Recruiting
• Hôpital Joseph Ducuing
  Toulouse, Haute Garonne, France Recruiting
• Clinique Médipole Garonne
  Toulouse, Haute Garonne, France Recruiting
• CHRU Brabois
  Nancy, Meurthe et Moselle, France Recruiting
• Clinique du Pré
  Le Mans, Sarthe, France Recruiting
• OCM Klinik GmbH
  München, Bavaria, Germany Recruiting

Study contacts

• Study coordinator: Solange VAN DE MOORTELE, PhD
• Email: s.vandemoortele@teknimed.com
• Phone: +33534252679

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.