Health TrialsbyHealthPanel

Bone Substitutes Outcomes - Post Market Follow-up

ConditionBone Resorption
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTeknimed

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

People presenting a bone defect created by surgical or traumatic injury.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Bone defect

    Device

    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 fusion

    Device

    Spinal fusion is a surgery procedure that reinforces your back structure and stability by linking two vertebrae together

  • Cage filling

    Device

    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.

Treatment groups

425 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: CERAFORM Granules Orthopedics1 intervention
Group B: CERAFORM Granules Spine1 intervention
Group C: CERAFORM Sticks Orthopedics1 intervention
Group D: CERAFORM Wedge Orthopedics1 intervention
Group E: TRIHA+ Spine1 intervention
Group F: TRIHA+ Orthopedics1 intervention
Group G: NANOGEL Spine1 intervention
Group H: NANOGEL Orthopedics1 intervention

Trial outcomes

Primary outcomes

1

Successful bone repair

Evaluated through the rate of revision surgery due to a failure of the substitute.

Time frame
24 months

Secondary outcomes

1

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
2

Bone reconstruction

Evaluated on X-Rays by the Lane and Shadu score and the healing stage

Time frame
24 months
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Teknimed

Lead sponsor

Source ClinicalTrials.gov
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