Actively Recruiting
Bone Substitutes Outcomes - Post Market Follow-up
Led by Teknimed · Updated on 2025-09-09
425
Participants Needed
6
Research Sites
576 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bone Substitutes Outcomes - Post Market Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years or older
- Willing to sign informed consent approved by IRB or EC or not opposed to use of clinical data (France)
- For prospective inclusion: scheduled for surgery needing TEKNIMED bone substitute use as per instructions
- For retrospective inclusion: had surgery with TEKNIMED bone substitute between January 1, 2015 and site initiation visit, informed of study and not opposed to data use or willing to sign consent at first follow-up
You will not qualify if you...
- Under trusteeship or guardianship
- Pregnant or breastfeeding women
- Procedures other than those stated in the indications section
- Allergic to product components
- For CERAFORM and TRIHA+: treatment of large bone defects without mechanical stabilization system
- For NANOGEL: use in vertebroplasty procedures
- For NANOGEL: subcutaneous use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Pôle Rachis Hôpital Privé d'Eure et Loir
Mainvilliers, Eure et Loir, France, 28300
Actively Recruiting
2
Hôpital Joseph Ducuing
Toulouse, Haute Garonne, France, 31000
Actively Recruiting
3
Clinique Médipole Garonne
Toulouse, Haute Garonne, France, 31100
Actively Recruiting
4
CHRU Brabois
Nancy, Meurthe et Moselle, France, 54000
Actively Recruiting
5
Clinique du Pré
Le Mans, Sarthe, France, 72000
Actively Recruiting
6
OCM Klinik GmbH
München, Bavaria, Germany, D-81369
Actively Recruiting
Research Team
S
Solange VAN DE MOORTELE, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
8
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