Safety and feasibility of a smart assistive bone-cement injection system: a cadaveric study

Journal of Orthopaedic Surgery and Research, 2025 · DOI: https://doi.org/10.1186/s13018-025-05680-9 · Published: March 4, 2025

Orthopedics Biomedical Musculoskeletal Medicine

Simple Explanation

Osteoporotic vertebral compression fractures (OVCF) are a significant cause of disability and mortality among elderly individuals. Percutaneous vertebral augmentation (PVA) is a common procedure to treat OVCF. A significant drawback of PVA is bone cement leakage, which can lead to spinal cord compression, nerve injury, pulmonary embolism, or cerebral embolism. This study introduces a smart assistive device designed to improve cement injection control and operator protection. This study uses cadaver specimens to explore the safety and feasibility of smart injection systems for PVA, with the aim of improving cement injection accuracy, distribution, and reducing surgeon's X-ray exposure.

Study Duration

Not specified

Participants

Two freshly frozen human cadaver specimens

Evidence Level

Not specified

Key Findings

1
The motorized injection group had significantly fewer intraoperative X-ray fluoroscopies compared to the manual injection group, indicating reduced radiation exposure for the surgeon.
2
Cement injection time was significantly shorter in the motorized injection group compared to the manual injection group.
3
Bone cement leakage outside the vertebral body was observed in 40% of vertebrae in the manual injection group, while no leakage occurred in the motorized injection group.

Research Summary

This study introduces a smart assistive bone-cement injection system for percutaneous vertebral augmentation (PVA) to overcome the shortcomings of currently used injection devices. The smart system demonstrated more precise control of bone cement injection dosage, better cement distribution, and remote activation, which reduces the X-ray intake of the surgeon. The cadaveric study suggests the feasibility and safety of the smart injection system; however, clinical studies are necessary to corroborate these results and investigate potential advantages and drawbacks in clinical practice.

Practical Implications

Improved Surgical Precision

The smart assistive system can improve the precision and control of bone cement injection during PVA, leading to better cement distribution within the vertebral body.

Reduced Radiation Exposure

The device's remote activation feature reduces the surgeon's exposure to X-ray radiation during the procedure.

Enhanced Patient Safety

By reducing cement leakage, the smart injection system may decrease the risk of complications such as spinal cord compression and pulmonary embolism.

Study Limitations

1
The study used cadaveric specimens, which may not fully replicate the conditions of a live surgical environment.
2
The sample size was limited due to the cost and availability of cadaveric specimens.
3
The study did not create an injury model that mimicked naturally occurring osteoporotic vertebral compression fractures (OVCF).

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