Phase
Condition
Bone Density
Treatment
Cage filling
Spine fusion
Bone defect
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be 18 years or older.
Be willing to sign an informed consent approved by IRB or EC (where applicable) ornot 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 bonesubstitutes comprised in this study is needed and intended to be used according tothe 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 inthe study (France) or be willing to sign an informed consent (where applicable)during the first follow-up visit following the site initiation.
Exclusion
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 structurewithout implementing a mechanical stabilisation system (such as plate(s), screw(s),nail(s), cage(s))
NANOGEL®:
Use in vertebroplasty procedures
Subcutaneous use
Study Design
Study Description
Connect with a study center
Pôle Rachis Hôpital Privé d'Eure et Loir
Mainvilliers, Eure Et Loir 28300
FranceActive - Recruiting
Clinique Médipole Garonne
Toulouse, Haute Garonne 31100
FranceActive - Recruiting
Hôpital Joseph Ducuing
Toulouse, Haute Garonne 31000
FranceActive - Recruiting
CHRU Brabois
Nancy, Meurthe Et Moselle 54000
FranceActive - Recruiting
Clinique du Pré
Le Mans, Sarthe 72000
FranceActive - Recruiting
OCM Klinik GmbH
München, Bavière D-81369
GermanyActive - Recruiting
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