Status:
RECRUITING
Bone Substitutes Outcomes - Post Market Follow-up
Lead Sponsor:
Teknimed
Conditions:
Bone Resorption
Eligibility:
All Genders
18+ years
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 lab...
Detailed Description
It is admitted that: * Surgeons are often concerned by bone void filling and they can choose between synthetic bone substitutes or bone grafts of animal or human origin. * Due to their chemical compo...
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
Key Trial Info
Start Date :
September 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2032
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT06374342
Start Date
September 16 2021
End Date
September 30 2032
Last Update
September 9 2025
Active Locations (6)
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1
Pôle Rachis Hôpital Privé d'Eure et Loir
Mainvilliers, Eure et Loir, France, 28300
2
Hôpital Joseph Ducuing
Toulouse, Haute Garonne, France, 31000
3
Clinique Médipole Garonne
Toulouse, Haute Garonne, France, 31100
4
CHRU Brabois
Nancy, Meurthe et Moselle, France, 54000