Neobone®

Introduction

A post-market clinical follow-up (PMCF) report analyzed 14 cases where Neobone® was used as a bone filler in extremities for trauma management and surgical bone voids/gaps in adult patients.

Study Overview

• Fractures were managed with fracture reduction, osteosynthesis material (plates and screws), and Neobone® wedges for bone void filling.
• Osteotomy techniques were applied for other conditions.
• Osteosynthesis materials were used in all cases except one.

Diagnosis

• Gonalgia: 72%
• Fractures: 21%
• Pseudoarthrosis: 7%

Anatomical Distribution

• Tibia: 86%
• Femur: 7%
• Calcaneus: 7%

Follow-up Outcomes

• All knee pain (gonalgia) patients reported complete pain relief post-surgery.
• Patients with fractures and pseudarthrosis showed positive bone healing (visible callus formation or bone consolidation on X-ray).
• Bone consolidation occurred at a median of 6 months (mean: 6.3 months).

Safety & Complications

• No adverse events directly linked to Neobone®.
• Two cases (14%) of postoperative complications:
• One wound infection requiring reoperation (device was not removed, and patient recovered).
• One pain event in the left ankle after knee fracture, managed with physiotherapy (not linked to Neobone®).

Conclusion

Neobone® demonstrated high safety and efficacy in orthopedic applications, showing effective bone consolidation and complete pain relief for gonalgia patients. The study found no direct device-related complications, reinforcing its reliability as a bone graft substitute in extremity surgeries.