SPINE BONE CEMENTS OUTCOMES

April 11, 2024 updated by: Teknimed

Safety and Clinical Performance Assessment of Bone Cements and Injection Systems Used in Spine Surgery - A Post-Market Clinical Follow-Up

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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
  • 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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67200
    • Eure Et Loir
      • Mainvilliers, Eure Et Loir, France, 28300
        • Recruiting
        • Pôle Rachis Hôpital Privé d'Eure et Loir
        • Contact:
        • Principal Investigator:
          • Jean MEYBLUM, MD
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31130
        • Recruiting
        • Hôpital Toulouse Purpan
        • Contact:
        • Principal Investigator:
          • Marie FARUCH, MD
    • Sarthe
      • Le Mans, Sarthe, France, 72100
        • Recruiting
        • Pôle Sud Santé
        • Contact:
        • Principal Investigator:
          • Alexandru NITULESCU, MD
    • Savoie
      • Chambéry, Savoie, France, 73000
  • Portugal
      • Lisbonne, Portugal, 1549-008
        • Recruiting
        • Hospitale Cruz Vermelha Portuguesa
        • Contact:
        • Principal Investigator:
          • Miguel CORDEIRO, MD
  • Spain
      • Barcelona, Spain, 08022
        • Recruiting
        • Clínica Teknon Instituto de neurociencias
        • Contact:
        • Principal Investigator:
          • David BOSCH GARCIA, MD
      • Granada, Spain, 18013
        • Recruiting
        • Hospital Neurotraumatologico
        • Contact:
        • Principal Investigator:
          • Fernando RUIZ SANTIAGO, MD
      • Murcia, Spain, 30120
        • Recruiting
        • Hospital Clinico Universitario Virgen de la Arrixaca
        • Contact:
        • Principal Investigator:
          • Gonzalo DE PACO TUDELA, MD
      • Terrassa, Spain, 08222
        • Recruiting
        • Fundacio Assistencial Mutua de Terrassa - Edifici Estació
        • Contact:
        • Principal Investigator:
          • David BOSCH GARCIA
      • Zafra, Spain, 06300
        • Recruiting
        • Hospital de Zafra
        • Contact:
        • Principal Investigator:
          • Félix PANTA ANTON, MD
  • Ukraine
      • Kiev, Ukraine, 1601
        • Recruiting
        • Institute of Traumatology and Orthopaedics
        • Contact:
        • Principal Investigator:
          • Andrii SHEVCHUK, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients suffering from painful vertebral compression fractures resulting from osteoporosis, benign or malignant lesions, or of traumatic origin

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
F20 VP
Vertebroplasty
Device: Vertebroplasty (VP)
Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
F20 KP
Kyphoplasty
Device: Kyphoplasty (KP)
Kyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
SPINEFIX VP
Vertebroplasty
Device: Vertebroplasty (VP)
Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
SPINEFIX KP
Kyphoplasty
Device: Kyphoplasty (KP)
Kyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
SPINEFIX PSA
Pedicular Screw Augmentation
Device: Pedicular Screw Augmentation (PSA)
Pedicular Screw Augmentation is a procedure in which a special medical-grade cement mixture is injected into pedicular screws in order to augment fixation strength
HIGH V+ VP
Vertebroplasty
Device: Vertebroplasty (VP)
Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
HIGH V+ KP
Kyphoplasty
Device: Kyphoplasty (KP)
Kyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
OPACITY+ VP
Vertebroplasty
Device: Vertebroplasty (VP)
Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
OPACITY+ KP
Kyphoplasty
Device: Kyphoplasty (KP)
Kyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alleviation of Pain
Time Frame: 24 months
Pain evaluated by Visual Analogue Scale (VAS): on a scale of 0 to 10, with 0 being no pain and 10 being the most severe pain at the Baseline and at the Follow-up visits
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration of quality of life
Time Frame: 24 months
Evaluated through short questions : Oswestry Disability Index (ODI score)
24 months
Patient satisfaction
Time Frame: 24 months

Evaluated through short questions :

A. Are you satisfied with your surgery? Yes/No/Without opinion B. Has your health improved? Yes/Stable/No C. Given the results, would you accept this intervention again? Yes/No/Without opinion
24 months
Stabilization of vertebrae
Time Frame: 24 months
Radiographic imaging
24 months
Adverse events
Time Frame: 10 years
All adverse events occured during surgery and through study completion
10 years
Antalgic Consumption
Time Frame: 24 months
Antalgic consumption and the drug type at the Baseline and at the Follow-up visits
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teknimed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2019

Primary Completion (Estimated)

September 4, 2029

Study Completion (Estimated)

September 30, 2039

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV01-TK-SPINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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