RecruitingNCT06374342

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

Sponsor

Teknimed

Enrollment

425 participants

Start Date

Sep 16, 2021

Study Type

OBSERVATIONAL

Conditions

Bone Resorption

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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.

Exclusion Criteria11

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

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Interventions

DEVICEBone 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.

DEVICESpine fusion

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

DEVICECage 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.