Collecting data on the safety and performance of TEKNIMED spine bone cements

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Solange VAN DE MOORTELE, PhD
• Email: s.vandemoortele@teknimed.com
• Phone: +33534252679

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Improving outcomes for patients with fragility fractures

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• AI detection of vertebral fractures on routine chest‑abdomen CT for men over 50

  This project will try AI software to find vertebral fractures on chest‑abdomen CT scans in men aged 50 and older who have CTs for reasons other than bone disease.

  Recruiting IRCCS San Raffaele · Milan, Italy · NCT06449742

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.