Status:
RECRUITING
Spine Bone Cements Outcomes - Post Market Follow-up
Lead Sponsor:
Teknimed
Conditions:
Vertebral Fracture
Compression Fracture
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 Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing an...
Detailed Description
It is admitted that: * Cementoplasty procedures such as vertebroplasty and kyphoplasty are recommended in the treatment of painful vertebral compression fractures, due to their efficiency and safety ...
Eligibility Criteria
Inclusion Criteria:
-
Be 18 years or older
-
Be willing to sign an informed consent approved by Ethic Committee (when applicable) or not being opposed to the use of their clinical data in the study
o For prospective inclusion:
-
Be considered for treatment with one of the TEKNIMED Spine Range cement comprised in this study
o For retrospective inclusion:
-
Have undergone a surgery with a TEKNIMED Spine Range cement between the 1st of January 2016 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 or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable).
Exclusion Criteria:
Patients presenting one of the following conditions will not be included (contraindications per IFU):
- Procedures other than those stated in the INDICATIONS section
- Coagulation disorders, or severe cardiopulmonary disease
- Unstable vertebral fractures
- Compromise of the vertebral body or of the pedicle walls
- Hypersensitivity or allergy to one of the constituents of the product
- Patient clearly improving on more conservative treatment
- Prophylactic use in spinal metastatic or osteoporotic patients with no evidence of acute fracture
- Paediatric patients and pregnant or breast-feeding women.
Key Trial Info
Start Date :
September 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2039
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06367582
Start Date
September 4 2019
End Date
September 30 2039
Last Update
September 9 2025
Active Locations (12)
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1
CHU HautePierre
Strasbourg, Bas-Rhin, France, 67200
2
Pôle Rachis Hôpital Privé d'Eure et Loir
Mainvilliers, Eure et Loir, France, 28300
3
Hôpital Toulouse Purpan
Toulouse, Haute Garonne, France, 31130
4
Pôle Sud Santé
Le Mans, Sarthe, France, 72100