Vertebral FractureNCT06367582
Spine Bone Cements Outcomes - Post Market Follow-up
An observational study of Vertebral Fracture and Compression Fracture, run by Teknimed at 12 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Fracture, Compression Fracture, Osteoporotic Fractures
- What is being tested?
- Vertebroplasty (VP), Kyphoplasty (KP) and Pedicular Screw Augmentation (PSA)
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 4 Sep 2019to 30 Sep 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients suffering from painful vertebral compression fractures resulting from osteoporosis, benign or malignant lesions, or of traumatic origin
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
12 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 4 countries
France5 sites, 5 recruiting
- Recruiting
Centre Hospitalier Métropole Savoie
Chambéry, Savoie, 73000
Cristian VASILE, MD, cristian.vasile@ch-metropole-savoie.fr
Cristian VASILE, MD
- Recruiting
Pôle Sud Santé
Le Mans, Sarthe, 72100
Alexandru NITULESCU, MD, alexandru_orto@yahoo.com
Alexandru NITULESCU, MD
- Recruiting
Pôle Rachis Hôpital Privé d'Eure et Loir
Mainvilliers, Eure et Loir, 28300
Jean MEYBLUM, MD, jeanmeyblum@hotmail.com
Jean MEYBLUM, MD
- Recruiting
CHU HautePierre
Strasbourg, Bas-Rhin, 67200
Vincent LAMAS, MD, vincent.lamas@chru-strasbourg.fr
Vincent LAMAS, MD
- Recruiting
Hôpital Toulouse Purpan
Toulouse, Haute Garonne, 31130
Marie FARUCH, MD, faruch.m@chu-toulouse.fr
Marie FARUCH, MD
Spain5 sites, 5 recruiting
- Recruiting
Clínica Teknon Instituto de neurociencias
Barcelona, 08022
Daniel CRUZ MIRANDA, MD, dr.jdcruz@gmail.com
David BOSCH GARCIA, MD
- Recruiting
Hospital Neurotraumatologico
Granada, 18013
Fernando RUIZ SANTIAGO, MD, ferusan12@gmail.com
Fernando RUIZ SANTIAGO, MD
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
Gonzalo DE PACO TUDELA, MD, gonzalodepaco@gmail.com
Gonzalo DE PACO TUDELA, MD
- Recruiting
Fundacio Assistencial Mutua de Terrassa - Edifici Estació
Terrassa, 08222
David BOSCH GARCIA, MD, dbosch@mutuaterrassa.com
David BOSCH GARCIA
- Recruiting
Hospital de Zafra
Zafra, 06300
Félix PANTA ANTON, MD, pantafelix74@gmail.com
Félix PANTA ANTON, MD
Portugal1 site, 1 recruiting
- Recruiting
Hospitale Cruz Vermelha Portuguesa
Lisbon, 1549-008
Miguel CORDEIRO, MD, 914655121, miguel.cordeiro@hcvp.com.pt
Miguel CORDEIRO, MD
Ukraine1 site, 1 recruiting
- Recruiting
Institute of Traumatology and Orthopaedics
Kiev, 1601
Andrii SHEVCHUK, MD, fasti@i.ua
Andrii SHEVCHUK, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Vertebroplasty (VP), Kyphoplasty (KP), Pedicular Screw Augmentation (PSA)
- Medical subject headings
- Spinal Fractures, Fractures, Compression, Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertebroplasty (VP)Device
Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
Kyphoplasty (KP)Device
Kyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
Pedicular Screw Augmentation (PSA)Device
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
| Study group | Role | What they receive |
|---|---|---|
| F20 VP | Vertebroplasty Receives: Device: Vertebroplasty (VP) | |
| F20 KP | Kyphoplasty Receives: Device: Kyphoplasty (KP) | |
| SPINEFIX VP | Vertebroplasty Receives: Device: Vertebroplasty (VP) | |
| SPINEFIX KP | Kyphoplasty Receives: Device: Kyphoplasty (KP) | |
| SPINEFIX PSA | Pedicular Screw Augmentation Receives: Device: Pedicular Screw Augmentation (PSA) | |
| HIGH V+ VP | Vertebroplasty Receives: Device: Vertebroplasty (VP) | |
| HIGH V+ KP | Kyphoplasty Receives: Device: Kyphoplasty (KP) | |
| OPACITY+ VP | Vertebroplasty Receives: Device: Vertebroplasty (VP) | |
| OPACITY+ KP | Kyphoplasty Receives: Device: Kyphoplasty (KP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alleviation of Pain
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
Measured: 24 months
Secondary outcomes (5)
Restoration of quality of life
Evaluated through short questions : Oswestry Disability Index (ODI score)
Measured: 24 months
Patient satisfaction
Evaluated through short questions :
- 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
Measured: 24 months
Stabilization of vertebrae
Radiographic imaging
Measured: 24 months
Adverse events
All adverse events occured during surgery and through study completion
Measured: 10 years
Antalgic Consumption
Antalgic consumption and the drug type at the Baseline and at the Follow-up visits
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start4 Sep 2019
- Primary completion4 Sep 2029 (estimated)
- Study completion30 Sep 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teknimed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367582
- Sponsor's protocol ID
- CV01-TK-SPINE
- Status last verified
- Sep 2025
- First submitted
- 11 Apr 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Clinical Performance Assessment of Bone Cements and Injection Systems Used in Spine Surgery - A Post-Market Clinical Follow-Up
- ClinicalTrials.gov ID
- NCT06367582
- Acronym / sponsor ID
- CV01-TK-SPINE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- TeknimedIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 4 Sep 2029 (estimated)
- Study completion
- 30 Sep 2039 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| F20 VP | – | Device: Vertebroplasty (VP)Vertebroplasty |
| F20 KP | – | Device: Kyphoplasty (KP)Kyphoplasty |
| SPINEFIX VP | – | Device: Vertebroplasty (VP)Vertebroplasty |
| SPINEFIX KP | – | Device: Kyphoplasty (KP)Kyphoplasty |
| SPINEFIX PSA | – | Device: Pedicular Screw Augmentation (PSA)Pedicular Screw Augmentation |
| HIGH V+ VP | – | Device: Vertebroplasty (VP)Vertebroplasty |
| HIGH V+ KP | – | Device: Kyphoplasty (KP)Kyphoplasty |
| OPACITY+ VP | – | Device: Vertebroplasty (VP)Vertebroplasty |
| OPACITY+ KP | – | Device: Kyphoplasty (KP)Kyphoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients suffering from painful vertebral compression fractures resulting from osteoporosis, benign or malignant lesions, or of traumatic origin
Key inclusion criteria (7 listed)
- 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
- Be considered for treatment with one of the TEKNIMED Spine Range cement comprised in this study
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vertebroplasty (VP)Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain | Device | F20 VP, HIGH V+ VP, OPACITY+ VP, SPINEFIX VP |
| Kyphoplasty (KP)Kyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain | Device | F20 KP, HIGH V+ KP, OPACITY+ KP, SPINEFIX KP |
| 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 | Device | SPINEFIX PSA |
Primary outcome
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
5 secondary outcomes
Restoration of quality of life
Time frame: 24 months
Patient satisfaction
Time frame: 24 months
Stabilization of vertebrae
Time frame: 24 months
Adverse events
Time frame: 10 years
Antalgic Consumption
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Fracture and Compression Fracture, run by Teknimed at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, Spain, Portugal, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Solange VAN DE MOORTELE, PhD (+33534252679, s.vandemoortele@teknimed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alleviation of Pain (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.