Cervical subtotal discectomy prosthesis validated in non-human primate model: A novel artiﬁcial cervical disc replacement concept?

Frontiers in Bioengineering and Biotechnology, 2022 · DOI: 10.3389/fbioe.2022.997877 · Published: October 13, 2022

Simple Explanation

This study introduces a new cervical subtotal discectomy prosthesis (CSDP) designed to replace damaged cervical discs while preserving part of the vertebral endplate. The CSDP was tested for biocompatibility and osseointegration in cell cultures and mice before being implanted in monkeys to assess its safety and biomechanical stability. Results showed the CSDP exhibited excellent safety, osseointegration, and biomechanical stability in the monkey model, suggesting it could be a promising alternative for treating cervical disc diseases.

Study Duration

18 Months

Participants

8 cynomolgus monkeys

Evidence Level

Level 5, Animal study

Key Findings

1
The CSDP constituent titanium alloy (Ti6Al4V-AO) showed extended adhesion, remarkable viability status, and cell proliferation when co-cultured with mouse embryo osteoblast precursor cells.
2
After implantation in the mouse femur, the Ti6Al4V-AO surface was covered by new cancellous bone, forming connections with the cortical bone, with no toxicity detected.
3
In primate models, the CSDP achieved fixation and bony fusion in the vertebral body at 1 year post-operation, with no signs of inflammation, spinal cord compression, or adjacent segment degeneration.

Research Summary

The study evaluated a novel cervical subtotal discectomy prosthesis (CSDP) in a non-human primate model, focusing on its safety, osseointegration, and biomechanical stability. The CSDP demonstrated excellent biocompatibility and osseointegration in vitro and in vivo, leading to successful implantation and bony fusion in the primate model. The findings suggest that the CSDP could be a promising new choice for treating cervical disc diseases, potentially improving outcomes for degenerative cervical conditions.

Practical Implications

Potential Alternative to Traditional Fusion

The CSDP offers a potential alternative to traditional cervical interbody fusion surgery, aiming to preserve cervical mobility and reduce adjacent segment disease.

Improved Prosthesis Design

The hemiarthroplasty-like design of the CSDP, retaining the lower endplate, and the ellipsoid-in-socket articulation may reduce complications associated with total disc replacement prostheses.

Future Clinical Trials

The successful validation in a non-human primate model supports the potential for future clinical trials to evaluate the effectiveness and safety of CSDP in human patients with cervical disc diseases.

Study Limitations

1
Non-human primates cannot verbally communicate their discomfort symptoms.
2
Only a single-segment operation was performed.
3
Post-surgery immunological and histopathological evaluations have not been performed.

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