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Spine Bone Cements Outcomes - Post Market Follow-up

Recruitingn/aAges 18 Years - anyAllTeknimed
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

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

12 sites
CHU HautePierre
Strasbourg, France
Pôle Rachis Hôpital Privé d'Eure et Loir
Mainvilliers, France
Hôpital Toulouse Purpan
Toulouse, France
Pôle Sud Santé
Le Mans, France
Centre Hospitalier Métropole Savoie
Chambéry, France
Hospitale Cruz Vermelha Portuguesa
Lisbon, Portugal
Clínica Teknon Instituto de neurociencias
Barcelona, Spain
Hospital Neurotraumatologico
Granada, Spain

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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