NCT06374342

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 425 (estimated)
• Sponsor: Teknimed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Bone Resorption

Interventions

Type	Name	Description
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.
DEVICE	Spine fusion	Spinal fusion is a surgery procedure that reinforces your back structure and stability by linking two vertebrae together
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.

Timeline

• Start date: 2021-09-16
• Primary completion: 2026-09-16
• Completion: 2032-09-30
• First posted: 2024-04-18
• Last updated: 2025-09-09

Locations

6 sites across 2 countries: France, Germany