Spine Bone Cements Outcomes - Post Market Follow-up
Recruiting now
Conditions studied: Vertebral Fracture, Compression Fracture, Osteoporotic Fractures
In brief
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 and injection systems, and all their private labels. TEKNIMED bone cements are legacy products, some marketed for more than 10 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.
Key facts
- Study ID
- NCT06367582
- Run by
- Teknimed
- People needed
- 500
- Starts
- 2019-09-04
- Expected to finish
- 2039-09-30
- Last updated by the study team
- 2025-09-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- CHU HautePierre — Strasbourg, Bas-Rhin, France (enrolling)
- Pôle Rachis Hôpital Privé d'Eure et Loir — Mainvilliers, Eure et Loir, France (enrolling)
- Hôpital Toulouse Purpan — Toulouse, Haute Garonne, France (enrolling)
- Pôle Sud Santé — Le Mans, Sarthe, France (enrolling)
- Centre Hospitalier Métropole Savoie — Chambéry, Savoie, France (enrolling)
- Hospitale Cruz Vermelha Portuguesa — Lisbon, Portugal (enrolling)
- Clínica Teknon Instituto de neurociencias — Barcelona, Spain (enrolling)
- Hospital Neurotraumatologico — Granada, Spain (enrolling)
- Hospital Clínico Universitario Virgen de la Arrixaca — Murcia, Spain (enrolling)
- Fundacio Assistencial Mutua de Terrassa - Edifici Estació — Terrassa, Spain (enrolling)
- Hospital de Zafra — Zafra, Spain (enrolling)
- Institute of Traumatology and Orthopaedics — Kiev, Ukraine (enrolling)
Full record on ClinicalTrials.gov
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