Bone Substitutes Outcomes - Post Market Follow-up

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Resorption
• Intervention / Treatment: Device: Bone defect; Device: Spine fusion; Device: Cage filling

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 Type: Observational
• Enrollment (Estimated): 425

Contacts and Locations

• Study Contact: Name: Solange VAN DE MOORTELE, PhD; Phone Number: +33534252679; Email: s.vandemoortele@teknimed.com

Study Locations

• France
  • Eure et Loir
    • Mainvilliers, Eure et Loir, France, 28300
      • Recruiting
      • Pôle Rachis Hôpital Privé d'Eure et Loir
      • Contact: Jean MEYBLUM, MD; Email: jeanmeyblum@hotmail.com
      • Principal Investigator: Jean MEYBLUM, MD
  • Haute Garonne
    • Toulouse, Haute Garonne, France, 31000
      • Recruiting
      • Hôpital Joseph Ducuing
      • Contact: Gérard GIORDANO, MD; Email: ortho.giordano@gmail.com
      • Principal Investigator: Gérard GIORDANO, MD
    • Toulouse, Haute Garonne, France, 31100
      • Recruiting
      • Clinique MEDIPOLE GARONNE
      • Contact: Dominique VARDON, MD; Email: dr-dominique.vardon@orange.fr
      • Principal Investigator: Dominique VARDON, MD
  • Meurthe et Moselle
    • Nancy, Meurthe et Moselle, France, 54000
      • Recruiting
      • Chru Brabois
      • Principal Investigator: Didier MAINARD, MD
      • Contact: Didier MAINARD, MD; Email: didier.mainard@univ-lorraine.fr
  • Sarthe
    • Le Mans, Sarthe, France, 72000
      • Recruiting
      • Clinique Du Pre
      • Contact: Jean-Patrick RAKOVER, MD; Phone Number: 02 43 77 54 21; Email: jeanpatrickrakover@me.com
      • Principal Investigator: Jean-Patrick RAKOVER, MD
• Germany
  • Bavaria
    • München, Bavaria, Germany, D-81369
      • Recruiting
      • OCM Klinik GmbH
      • Contact: Markus SCHROEDEL, MD; Email: Markus.schroedel@ocm-muenchen.de
      • Principal Investigator: Markus SCHROEDEL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CERAFORM Granules Orthopedics; 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.
CERAFORM Granules Spine; Spinal fusion	Device: Spine fusion; Spinal fusion is a surgery procedure that reinforces your back structure and stability by linking two vertebrae together
CERAFORM Sticks Orthopedics; 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.
CERAFORM Wedge Orthopedics; 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.
TRIHA+ Spine; Spinal fusion	Device: Spine fusion; Spinal fusion is a surgery procedure that reinforces your back structure and stability by linking two vertebrae together
TRIHA+ Orthopedics; 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.
NANOGEL Spine; Cage filling	Device: Cage filling; 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.
NANOGEL Orthopedics; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful bone repair	Evaluated through the rate of revision surgery due to a failure of the substitute.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months
Bone reconstruction	Evaluated on X-Rays by the Lane and Shadu score and the healing stage	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	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	24 months

Collaborators and Investigators

• Sponsor: Teknimed

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Estimated): September 16, 2026
• Study Completion (Estimated): September 30, 2032

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Gel; Hydroxyapatite; Calcium phosphate; Tricalcium phosphate; Bone substitutes; Ceramics
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Bone Resorption
• Other Study ID Numbers: SO01-TK-SUBSTITUTES

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
• product manufactured in and exported from the U.S.: No