An observational study in Bone Resorption, sponsored by Teknimed. Recruiting at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Teknimed · Observational
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.
It is admitted that:
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.
167 studies on the registry are indexed under Bone Resorption; 28 are open to participants now.
This study's planned enrollment of 425 is above the median of 43 across 18 observational studies indexed under Bone Resorption.
Browse Bone Resorption studies →Teknimed is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
People presenting a bone defect created by surgical or traumatic injury.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Be willing to sign an 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:
Exclusion Criteria:
Patients presenting one of the following conditions will not be included:
According to per IFU:
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®:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bone grafting
Device: Bone defect
Spinal fusion
Device: Spine fusion
Bone grafting
Device: Bone defect
Bone grafting
Device: Bone defect
Spinal fusion
Device: Spine fusion
Bone grafting
Device: Bone defect
Cage filling
Device: Cage filling
Bone grafting
Device: Bone defect
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.
Spinal fusion is a surgery procedure that reinforces your back structure and stability by linking two vertebrae together
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.
Successful bone repair
Evaluated through the rate of revision surgery due to a failure of the substitute.
Time frame: 24 months
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
Time frame: 24 months
Bone reconstruction
Evaluated on X-Rays by the Lane and Shadu score and the healing stage
Time frame: 24 months
Well-being
Evaluated through a series of short questions : On a scale from 0 (Not at all) to 10 (Perfectly well) 1. Are you satisfied with your global health status? \_\_\_\_\_ / 10 2. Do you manage to carry out your day-to-day activities? \_\_\_\_\_ / 10 3. Do you manage to achieve what you would like? \_\_\_\_\_ / 10 4. Do you feel relaxed \_\_\_\_\_ / 10 5. Do you feel fit / with energy? \_\_\_\_\_ / 10 6. Do your physical, psychic and emotional conditions allow you to enjoy your relationships with others? \_\_\_\_\_ / 10
Time frame: 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
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
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