Collecting data on the safety and performance of TEKNIMED spine bone cements
Safety and Clinical Performance Assessment of Bone Cements and Injection Systems Used in Spine Surgery - A Post-Market Clinical Follow-Up
This study is trying to see how safe and effective TEKNIMED's spine bone cements are for patients who have had procedures like vertebroplasty and kyphoplasty.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Teknimed Industry-sponsored |
| Locations | 12 sites (Strasbourg, Bas-Rhin and 11 other locations) |
| Trial ID | NCT06367582 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather clinical data on the safety and effectiveness of TEKNIMED's range of spine bone cements used in procedures like vertebroplasty and kyphoplasty. It includes both retrospective and prospective data collection from patients who have undergone treatment with these cements. The study will follow patients according to local standard medical care, assessing outcomes in a real-life clinical setting. The goal is to confirm previously established safety and performance claims of these products.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing treatment with TEKNIMED spine bone cements for vertebral compression fractures.
Not a fit: Patients with coagulation disorders, severe cardiopulmonary disease, or unstable vertebral fractures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of TEKNIMED spine bone cements, potentially improving patient outcomes.
How similar studies have performed: Previous studies on similar bone cement products have shown positive outcomes, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Strasbourg, Bas-Rhin and 11 other locations
- CHU HautePierre — Strasbourg, Bas-Rhin, France (Recruiting)
- Pôle Rachis Hôpital Privé d'Eure et Loir — Mainvilliers, Eure et Loir, France (Recruiting)
- Hôpital Toulouse Purpan — Toulouse, Haute Garonne, France (Recruiting)
- Pôle Sud Santé — Le Mans, Sarthe, France (Recruiting)
- Centre Hospitalier Métropole Savoie — Chambéry, Savoie, France (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)
Study contacts
- Study coordinator: Solange VAN DE MOORTELE, PhD
- Email: s.vandemoortele@teknimed.com
- Phone: +33534252679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.