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Clinical Trials in France / NCT06367582
Recruiting Observational

Spine Bone Cements Outcomes - Post Market Follow-up

NCT06367582 · tracked via the Priya Life Science France tracker
Sponsor
Teknimed
Phase
Observational
Started
2019-09-04
Last updated
2025-09-09

Condition(s) studied

Vertebral FractureCompression FractureOsteoporotic Fractures

Investigational drug(s) / intervention(s)

Vertebroplasty (VP)Kyphoplasty (KP)Pedicular Screw Augmentation (PSA)

Vertebroplasty (VP): Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain

Kyphoplasty (KP): Kyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain

Pedicular Screw Augmentation (PSA): Pedicular Screw Augmentation is a procedure in which a special medical-grade cement mixture is injected into pedicular screws in order to augment fixation strength

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
CHU HautePierre Strasbourg Bas-Rhin Recruiting
Pôle Rachis Hôpital Privé d'Eure et Loir Mainvilliers Eure et Loir Recruiting
Hôpital Toulouse Purpan Toulouse Haute Garonne Recruiting
Pôle Sud Santé Le Mans Sarthe Recruiting
Centre Hospitalier Métropole Savoie Chambéry Savoie Recruiting
Hospitale Cruz Vermelha Portuguesa Lisbon Portugal Recruiting
Clínica Teknon Instituto de neurociencias Barcelona Spain Recruiting
Hospital Neurotraumatologico Granada Spain Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca Murcia Spain Recruiting
Fundacio Assistencial Mutua de Terrassa - Edifici Estació Terrassa Spain Recruiting
Hospital de Zafra Zafra Spain Recruiting
Institute of Traumatology and Orthopaedics Kiev Ukraine Recruiting

More Teknimed trials in France

Sport Surgery Products Outcomes - A Post-market Follow-up Recruiting
Arthroplasty Cements Outcomes - A Post-market Follow-up Recruiting
Bone Substitutes Outcomes - Post Market Follow-up Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06367582 on ClinicalTrials.gov ↗ ← All trials in France