Bone Substitutes Outcomes - Post Market Follow-up
Recruiting now
Conditions studied: Bone Resorption
In brief
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.
Key facts
- Study ID
- NCT06374342
- Run by
- Teknimed
- People needed
- 425
- Starts
- 2021-09-16
- Expected to finish
- 2032-09-30
- Last updated by the study team
- 2025-09-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Pôle Rachis Hôpital Privé d'Eure et Loir — Mainvilliers, Eure et Loir, France (enrolling)
- Hôpital Joseph Ducuing — Toulouse, Haute Garonne, France (enrolling)
- Clinique Médipole Garonne — Toulouse, Haute Garonne, France (enrolling)
- CHRU Brabois — Nancy, Meurthe et Moselle, France (enrolling)
- Clinique du Pré — Le Mans, Sarthe, France (enrolling)
- OCM Klinik GmbH — München, Bavaria, Germany (enrolling)
Full record on ClinicalTrials.gov
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