Cervical Disc Arthroplasty: Current Evidence and Real-World Application.

Area of Science:

• Spine surgery
• Orthopedics
• Biomedical engineering

Background:

• Cervical total disc replacement (cTDR) emerged in the early 2000s.
• Despite its relative novelty, a substantial body of literature exists on cTDR.
• Global research and clinical application trends require synthesis.

Purpose of the Study:

• To comprehensively review and report the global status of cervical total disc replacement (cTDR) research and clinical use.
• To analyze literature from the United States (US) and internationally.
• To synthesize evidence supporting cTDR's efficacy and indications.

Main Methods:

• Systematic literature review of publications with clinical patient populations.
• Exclusion of biomechanical, cadaver, technique-specific, and case study papers.
• Analysis of US-based studies (often FDA IDE trials) and international studies.

Main Results:

• US literature predominantly features Level I evidence supporting cTDR for 1-2 levels versus anterior cervical discectomy and fusion.
• International studies, while often smaller and less controlled, explore broader surgical indications for cTDR.
• Key complications like secondary surgery, heterotopic ossification, and adjacent segment degeneration are consistently studied.

Conclusions:

• Robust evidence supports cervical total disc replacement (cTDR) for various clinical indications.
• International research contributes to expanding patient indications for cTDR.
• Addressing regulatory and health economic challenges is crucial for cTDR's advancement.