Collecting data on the safety and performance of TEKNIMED bone substitutes

Safety and Clinical Performance Assessment of Bone Substitutes Used for Bone Voids Filling - A Post-Market Clinical Follow-Up

This study is testing how safe and effective TEKNIMED's bone substitutes are for patients who have had surgeries that needed these products.

Quick facts

• Study type: Observational
• Enrollment: 425 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Teknimed (industry)
• Locations: 6 sites (Mainvilliers, Eure et Loir and 5 other locations)
• Trial ID: NCT06374342 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are undergoing surgery requiring bone filling with TEKNIMED substitutes.

Not a fit: Patients who are pregnant, breastfeeding, or under legal guardianship will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable evidence supporting the use of TEKNIMED bone substitutes, potentially improving patient outcomes in bone defect surgeries.

How similar studies have performed: Previous studies have demonstrated the safety and efficacy of synthetic bone substitutes, making this approach consistent with established findings.

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

Where this trial is running

Mainvilliers, Eure et Loir and 5 other locations

• 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

Conditions: Bone Resorption, Bone substitutes, Gel, Hydroxyapatite, Tricalcium phosphate, Calcium phosphate, Ceramics