Bone ResorptionNCT06374342
Bone Substitutes Outcomes - Post Market Follow-up
An observational study of Bone Resorption, run by Teknimed at 6 sites in 2 countries.
Trial summary
A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels. TEKNIMED bone substitutes are legacy products, some marketed for more than 20 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Bone defect, Spine fusion and Cage filling
- Type of treatment
- Medical device
- How many people
- 425 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 16 Sep 2021to 30 Sep 2032
- 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: People presenting a bone defect created by surgical or traumatic injury.
Who may be able to join
- Be 18 years or older.
- Be willing to sign an informed consent approved by IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France) and
- o For prospective inclusion:
- Be considered for a surgery where bone filling with one of the TEKNIMED bone substitutes comprised in this study is needed and intended to be used according to the IFU.
- o For retrospective inclusion:
- Have undergone a surgery with a TEKNIMED bone substitute used according to the IFU, between the 1st January 2015 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 (France) or be willing to sign an informed consent (where applicable) during the first follow-up visit following the site initiation.
Who cannot join
- Patients presenting one of the following conditions will not be included:
- Under trusteeship or guardianship
- Pregnancy or breast-feeding women
- According to contraindications per IFU:
- Procedures other than those stated in the INDICATIONS section
- Patients susceptible to allergic reactions to the product components.
Show all 11Show fewer
- CERAFORM®, TRIHA+®:
- Treatment of large bone defects which could impact the stability of bone structure without implementing a mechanical stabilisation system (such as plate(s), screw(s), nail(s), cage(s))
- NANOGEL®:
- Use in vertebroplasty procedures
- Subcutaneous use
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
France5 sites, 5 recruiting
- Recruiting
Clinique du Pré
Le Mans, Sarthe, 72000
Jean-Patrick RAKOVER, MD, 02 43 77 54 21, jeanpatrickrakover@me.com
Jean-Patrick RAKOVER, 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
CHRU Brabois
Nancy, Meurthe et Moselle, 54000
Didier MAINARD, MD, didier.mainard@univ-lorraine.fr
Didier MAINARD, MD
- Recruiting
Hôpital Joseph Ducuing
Toulouse, Haute Garonne, 31000
Gérard GIORDANO, MD, ortho.giordano@gmail.com
Gérard GIORDANO, MD
- Recruiting
Clinique Médipole Garonne
Toulouse, Haute Garonne, 31100
Dominique VARDON, MD, dr-dominique.vardon@orange.fr
Dominique VARDON, MD
Germany1 site, 1 recruiting
- Recruiting
OCM Klinik GmbH
München, Bavaria, D-81369
Markus SCHROEDEL, MD, Markus.schroedel@ocm-muenchen.de
Markus SCHROEDEL, MD
About this study
Official title: Safety and Clinical Performance Assessment of Bone Substitutes Used for Bone Voids Filling - 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 Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels.
TEKNIMED bone substitutes are legacy products, some marketed for more than 20 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:
- Surgeons are often concerned by bone void filling and they can choose between synthetic bone substitutes or bone grafts of animal or human origin.
- Due to their chemical composition similar to bone tissue, synthetic bone substitutes are an interesting alternative to autografts and allografts which present some inconvenient (quantity to sample, infection of sampling site…).
- Bone substitutes are bioresorbable and replaced by bone during the healing process (bone remodelling).
- Nowadays, bone substitutes represent a common and efficient procedure to treat surgical or traumatic osseous defects. They are indicated and used in various pathologies and types of surgery, but they always have the same intended use: to fill a bone void.
- Bone substitutes are also used in spine surgeries for cage filling and/or posterolateral fusion.
TEKNIMED has developed several bone substitutes currently used in various types of surgery. Due to their increasing use, there is a need of real-life safety and efficacy data on these products.
This retro-prospective study is performed to assess the safety and performance of TEKNIMED bone substitutes in their current clinical use.
- Conditions
- Bone Resorption
- Being tested
- Bone defect, Spine fusion, Cage filling
- Keywords
- Bone substitutes, Gel, Hydroxyapatite, Tricalcium phosphate, Calcium phosphate, Ceramics
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone defectDevice
Bone grafting is a procedure where damaged bones can be repaired or rebuilt using transplanted bone from another source. Sources for transplant bone include the patient (autograft), a cadaver (allograft) or synthetic bone.
Spine fusionDevice
Spinal fusion is a surgery procedure that reinforces your back structure and stability by linking two vertebrae together
Cage fillingDevice
Intervertebral fusion with cages is a surgical procedure used to stabilize the spine by fusing adjacent vertebrae. The cages, typically made of materials like titanium or plastic, and pre-filled with bone graft substitutes are placed between the vertebrae to maintain the proper spacing and alignment.
| Study group | Role | What they receive |
|---|---|---|
| CERAFORM Granules Orthopedics | Bone grafting Receives: Device: Bone defect | |
| CERAFORM Granules Spine | Spinal fusion Receives: Device: Spine fusion | |
| CERAFORM Sticks Orthopedics | Bone grafting Receives: Device: Bone defect | |
| CERAFORM Wedge Orthopedics | Bone grafting Receives: Device: Bone defect | |
| TRIHA+ Spine | Spinal fusion Receives: Device: Spine fusion | |
| TRIHA+ Orthopedics | Bone grafting Receives: Device: Bone defect | |
| NANOGEL Spine | Cage filling Receives: Device: Cage filling | |
| NANOGEL Orthopedics | Bone grafting Receives: Device: Bone defect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful bone repair
Evaluated through the rate of revision surgery due to a failure of the substitute.
Measured: 24 months
Secondary outcomes (4)
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
Bone reconstruction
Evaluated on X-Rays by the Lane and Shadu score and the healing stage
Measured: 24 months
Well-being
Evaluated through a series of short questions : On a scale from 0 (Not at all) to 10 (Perfectly well)
- Are you satisfied with your global health status? _____ / 10
- Do you manage to carry out your day-to-day activities? _____ / 10
- Do you manage to achieve what you would like? _____ / 10
- Do you feel relaxed _____ / 10
- Do you feel fit / with energy? _____ / 10
- Do your physical, psychic and emotional conditions allow you to enjoy your relationships with others? _____ / 10
Measured: 24 months
Patient satisfaction
Evaluated through a series of 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 do this intervention again? YES/NO/Without opinion
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 posted18 Apr 2024
- Study start16 Sep 2021
- Primary completion16 Sep 2026 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies 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
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teknimed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374342
- Sponsor's protocol ID
- SO01-TK-SUBSTITUTES
- Status last verified
- Sep 2025
- First submitted
- 16 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 Substitutes Used for Bone Voids Filling - A Post-Market Clinical Follow-Up
- ClinicalTrials.gov ID
- NCT06374342
- Acronym / sponsor ID
- SO01-TK-SUBSTITUTES
- Conditions
- Bone Resorption
- Keywords
- Bone substitutes, Gel, Hydroxyapatite, Tricalcium phosphate, Calcium phosphate, Ceramics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- TeknimedIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 16 Sep 2026 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 18 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 Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels.
TEKNIMED bone substitutes are legacy products, some marketed for more than 20 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:
- Surgeons are often concerned by bone void filling and they can choose between synthetic bone substitutes or bone grafts of animal or human origin.
- Due to their chemical composition similar to bone tissue, synthetic bone substitutes are an interesting alternative to autografts and allografts which present some inconvenient (quantity to sample, infection of sampling site…).
- Bone substitutes are bioresorbable and replaced by bone during the healing process (bone remodelling).
- Nowadays, bone substitutes represent a common and efficient procedure to treat surgical or traumatic osseous defects. They are indicated and used in various pathologies and types of surgery, but they always have the same intended use: to fill a bone void.
- Bone substitutes are also used in spine surgeries for cage filling and/or posterolateral fusion.
TEKNIMED has developed several bone substitutes currently used in various types of surgery. Due to their increasing use, there is a need of real-life safety and efficacy data on these products.
This retro-prospective study is performed to assess the safety and performance of TEKNIMED bone substitutes in their current clinical use.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| CERAFORM Granules Orthopedics | – | Device: Bone defectBone grafting |
| CERAFORM Granules Spine | – | Device: Spine fusionSpinal fusion |
| CERAFORM Sticks Orthopedics | – | Device: Bone defectBone grafting |
| CERAFORM Wedge Orthopedics | – | Device: Bone defectBone grafting |
| TRIHA+ Spine | – | Device: Spine fusionSpinal fusion |
| TRIHA+ Orthopedics | – | Device: Bone defectBone grafting |
| NANOGEL Spine | – | Device: Cage fillingCage filling |
| NANOGEL Orthopedics | – | Device: Bone defectBone grafting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People presenting a bone defect created by surgical or traumatic injury.
Key inclusion criteria (7 listed)
- Be 18 years or older.
- Be willing to sign an informed consent approved by IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France) and
- Be considered for a surgery where bone filling with one of the TEKNIMED bone substitutes comprised in this study is needed and intended to be used according to the IFU.
- Have undergone a surgery with a TEKNIMED bone substitute used according to the IFU, between the 1st January 2015 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 (France) or be willing to sign an informed consent (where applicable) during the first follow-up visit following the site initiation.
Key exclusion criteria (11 listed)
- Under trusteeship or guardianship
- Pregnancy or breast-feeding women
- Procedures other than those stated in the INDICATIONS section
- Patients susceptible to allergic reactions to the product components.
- Treatment of large bone defects which could impact the stability of bone structure without implementing a mechanical stabilisation system (such as plate(s), screw(s), nail(s), cage(s))
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 |
|---|---|---|
| Bone defectBone grafting is a procedure where damaged bones can be repaired or rebuilt using transplanted bone from another source. Sources for transplant bone include the patient (autograft), a cadaver (allograft) or synthetic bone. | Device | CERAFORM Granules Orthopedics, CERAFORM Sticks Orthopedics, CERAFORM Wedge Orthopedics, NANOGEL Orthopedics, TRIHA+ Orthopedics |
| Spine fusionSpinal fusion is a surgery procedure that reinforces your back structure and stability by linking two vertebrae together | Device | CERAFORM Granules Spine, TRIHA+ Spine |
| Cage fillingIntervertebral fusion with cages is a surgical procedure used to stabilize the spine by fusing adjacent vertebrae. The cages, typically made of materials like titanium or plastic, and pre-filled with bone graft substitutes are placed between the vertebrae to maintain the proper spacing and alignment. | Device | NANOGEL Spine |
Primary outcome
Successful bone repair
Time frame: 24 months
Evaluated through the rate of revision surgery due to a failure of the substitute.
4 secondary outcomes
Alleviation of Pain
Time frame: 24 months
Bone reconstruction
Time frame: 24 months
Well-being
Time frame: 24 months
Patient satisfaction
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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Resorption, run by Teknimed at 6 sites in 2 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 11 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 6 sites in France, Germany. 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?
Successful bone repair (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.