Spine Bone Cements Outcomes - Post Market Follow-up

Last updated: September 2, 2025
Sponsor: Teknimed
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Bone Fractures

Treatment

Vertebroplasty (VP)

Pedicular Screw Augmentation (PSA)

Kyphoplasty (KP)

Clinical Study ID

NCT06367582
CV01-TK-SPINE
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 inthis study o For retrospective inclusion:

  • Have undergone a surgery with a TEKNIMED Spine Range cement between the 1st ofJanuary 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 inthe study or be willing to sign an informed consent during the first follow-up visitfollowing the site initiation (when applicable).

Exclusion

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 ofacute fracture

  • Paediatric patients and pregnant or breast-feeding women.

Study Design

Total Participants: 500
Treatment Group(s): 3
Primary Treatment: Vertebroplasty (VP)
Phase:
Study Start date:
September 04, 2019
Estimated Completion Date:
September 30, 2039

Study 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

  • These mini-invasive procedures, where bone cement is injected into a partially collapsed vertebral body, are used to reduce pain and to provide mechanical stability

  • In most patients, a rapid pain relief and an increase in mobility and quality of life are obtained

  • Serious complications from bone cements leaks and adjacent vertebral fractures can be observed but remain rather rare

  • The use of spinal cement in pedicle screw augmentation procedures can be relevant to increase the strength of the screw fixation in the bone, particularly in osteoporotic patients.

TEKNIMED has developed several bone cements currently used in vertebroplasty and kyphoplasty procedures in the treatment of vertebral weakness. Among those, one cement is also used in pedicle screw augmentation procedures.

With the increasing use of these procedures, there is a need of real-life safety and efficacy data on the bone cements.

This retro-prospective study is performed to confirm the safety and performance of TEKNIMED spine bone cements in their current clinical use.

Connect with a study center

  • CHU HautePierre

    Strasbourg, Bas-Rhin 67200
    France

    Site Not Available

  • CHU HautePierre

    Strasbourg 2973783, Bas-Rhin 67200
    France

    Active - Recruiting

  • Pôle Rachis Hôpital Privé d'Eure et Loir

    Mainvilliers, Eure Et Loir 28300
    France

    Site Not Available

  • Pôle Rachis Hôpital Privé d'Eure et Loir

    Mainvilliers 2996645, Eure et Loir 28300
    France

    Active - Recruiting

  • Hôpital Toulouse Purpan

    Toulouse, Haute Garonne 31130
    France

    Site Not Available

  • Hôpital Toulouse Purpan

    Toulouse 2972315, Haute Garonne 31130
    France

    Active - Recruiting

  • Pôle Sud Santé

    Le Mans, Sarthe 72100
    France

    Site Not Available

  • Pôle Sud Santé

    Le Mans 3003603, Sarthe 72100
    France

    Active - Recruiting

  • Centre Hospitalier Métropole Savoie

    Chambéry, Savoie 73000
    France

    Site Not Available

  • Centre Hospitalier Métropole Savoie

    Chambéry 3027422, Savoie 73000
    France

    Active - Recruiting

  • Hospitale Cruz Vermelha Portuguesa

    Lisbon 2267057, 1549-008
    Portugal

    Active - Recruiting

  • Hospitale Cruz Vermelha Portuguesa

    Lisbonne, 1549-008
    Portugal

    Site Not Available

  • Clínica Teknon Instituto de neurociencias

    Barcelona, 08022
    Spain

    Site Not Available

  • Clínica Teknon Instituto de neurociencias

    Barcelona 3128760, 08022
    Spain

    Active - Recruiting

  • Hospital Neurotraumatologico

    Granada, 18013
    Spain

    Site Not Available

  • Hospital Neurotraumatologico

    Granada 2517117, 18013
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120
    Spain

    Site Not Available

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia 2513416, 30120
    Spain

    Active - Recruiting

  • Fundacio Assistencial Mutua de Terrassa - Edifici Estació

    Terrassa, 08222
    Spain

    Site Not Available

  • Fundacio Assistencial Mutua de Terrassa - Edifici Estació

    Terrassa 3108286, 08222
    Spain

    Active - Recruiting

  • Hospital de Zafra

    Zafra, 06300
    Spain

    Site Not Available

  • Hospital de Zafra

    Zafra 2509377, 06300
    Spain

    Active - Recruiting

  • Institute of Traumatology and Orthopaedics

    Kiev, 1601
    Ukraine

    Site Not Available

  • Institute of Traumatology and Orthopaedics

    Kiev 703448, 1601
    Ukraine

    Active - Recruiting

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