NCT06374342 Bone Substitutes Outcomes - Post Market Follow-up
| NCT ID | NCT06374342 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Teknimed |
| Condition | Bone Resorption |
| Study Type | OBSERVATIONAL |
| Enrollment | 425 participants |
| Start Date | 2021-09-16 |
| Primary Completion | 2026-09-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 425 participants in total. It began in 2021-09-16 with a primary completion date of 2026-09-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06374342 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bone Resorption. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06374342 currently recruiting?
Yes, NCT06374342 is actively recruiting participants. Contact the research team at s.vandemoortele@teknimed.com for enrollment information.
Where is the NCT06374342 trial being conducted?
This trial is being conducted at Mainvilliers, France, Toulouse, France, Toulouse, France, Nancy, France and 2 additional locations.
Who is sponsoring the NCT06374342 clinical trial?
NCT06374342 is sponsored by Teknimed. The trial plans to enroll 425 participants.