Bone Substitutes Outcomes - Post Market Follow-up

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.

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