n-IBS® — Spinal Surgeries

Introduction

A post-market clinical follow-up report analyzed 130 spinal surgeries performed in 2018 at Hospital Lusíadas, Lisbon, assessing the performance and safety of n-IBS® in various spine procedures.

Study Overview

• Clinical data was available for 102 cases (78.5%), with 59 cases fully completed for analysis.
• Bone consolidation rate: 85% among fully evaluated cases.

Patient Demographics

• Most patients were female (61%).
• 85% of patients were aged between 18-59 years old (average age: 49.9 years).
• n-IBS® was always used in combination with other medical devices such as intersomatic cages and spinous process fixation devices.

Anatomical Distribution

• 16% of patients reported persistent pain post-surgery.
• 10 cases of postoperative pain, managed with medication or physiotherapy.
• In 30% of cases (3 patients), pain resolved completely by the last follow-up.
• In 60% of cases, pain led to moderate disability, affecting daily activities.
• No adverse events related to n-IBS®.
• Any pain reported was attributed to the underlying medical condition rather than the device.

Conclusion

The use of n-IBS® in spinal surgeries demonstrated a high bone consolidation rate (85%) and good safety profile, with no device-related complications. The results suggest that n-IBS® is an effective and well-tolerated bone graft substitute in spine surgery applications.