Status:

RECRUITING

Spine Bone Cements Outcomes - Post Market Follow-up

Lead Sponsor:

Teknimed

Conditions:

Vertebral Fracture

Compression Fracture

Eligibility:

All Genders

18+ years

Brief 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 an...

Detailed Description

It is admitted that: * Cementoplasty procedures such as vertebroplasty and kyphoplasty are recommended in the treatment of painful vertebral compression fractures, due to their efficiency and safety ...

Eligibility 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.

Key Trial Info

Start Date :

September 4 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 30 2039

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT06367582

Start Date

September 4 2019

End Date

September 30 2039

Last Update

September 9 2025

Active Locations (12)

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Page 1 of 3 (12 locations)

1

CHU HautePierre

Strasbourg, Bas-Rhin, France, 67200

2

Pôle Rachis Hôpital Privé d'Eure et Loir

Mainvilliers, Eure et Loir, France, 28300

3

Hôpital Toulouse Purpan

Toulouse, Haute Garonne, France, 31130

4

Pôle Sud Santé

Le Mans, Sarthe, France, 72100