Bone Substitutes Outcomes - Post Market Follow-up

NCT06374342 | Recruiting

• 1 other identifier: SO01-TK-SUBSTITUTES
• Study Type: observational
• Target: 425
• Locations: 2 countries
• Sites: 6

Brief 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. 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.

Conditions

Bone Resorption

Keywords

Bone substitutes; Gel; Hydroxyapatite; Tricalcium phosphate; Calcium phosphate; Ceramics

Outcome Measures

Primary Outcomes (1)

• Successful bone repair

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

  24 months

Secondary Outcomes (4)

• Alleviation of Pain

  24 months

• Bone reconstruction

  24 months

• Well-being

  24 months

• Patient satisfaction

  24 months

Study Arms (8)

CERAFORM Granules Orthopedics

Bone grafting

Device: Bone defect

CERAFORM Granules Spine

Spinal fusion

Device: Spine fusion

CERAFORM Sticks Orthopedics

Bone grafting

Device: Bone defect

CERAFORM Wedge Orthopedics

Bone grafting

Device: Bone defect

TRIHA+ Spine

Spinal fusion

Device: Spine fusion

TRIHA+ Orthopedics

Bone grafting

Device: Bone defect

NANOGEL Spine

Cage filling

Device: Cage filling

NANOGEL Orthopedics

Bone grafting

Device: Bone defect

Interventions

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.

CERAFORM Granules Orthopedics; CERAFORM Sticks Orthopedics; CERAFORM Wedge Orthopedics; NANOGEL Orthopedics; TRIHA+ Orthopedics

Spine fusion DEVICE

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

CERAFORM Granules Spine; TRIHA+ Spine

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.

NANOGEL Spine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Teknimed: lead

Study Sites (6)

Pôle Rachis Hôpital Privé d'Eure et Loir

Mainvilliers, Eure et Loir, 28300, France

RECRUITING

Hôpital Joseph Ducuing

Toulouse, Haute Garonne, 31000, France

RECRUITING

Clinique Médipole Garonne

Toulouse, Haute Garonne, 31100, France

RECRUITING

CHRU Brabois

Nancy, Meurthe et Moselle, 54000, France

RECRUITING

Clinique du Pré

Le Mans, Sarthe, 72000, France

RECRUITING

OCM Klinik GmbH

München, Bavaria, D-81369, Germany

RECRUITING

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Solange VAN DE MOORTELE, PhD

CONTACT

+33534252679; s.vandemoortele@teknimed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 18, 2024
• Study Start: September 16, 2021
• Primary Completion (Estimated): September 16, 2026
• Study Completion (Estimated): September 30, 2032
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5); DE (1)