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Patient Selection in Cervical Disc Arthroplasty.

Pierce Nunley1, Kelly Frank1, Marcus Stone1

  • 1Spine Institute of Louisiana, Shreveport, Louisiana.

International Journal of Spine Surgery
|September 30, 2020
PubMed
Summary

Patient selection for cervical disc arthroplasty (CDA) in the US is debated. Current data lack evidence to support expanding FDA indications, necessitating further research before wider adoption.

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Area of Science:

  • Spine surgery
  • Orthopedics
  • Neurosurgery

Background:

  • Cervical disc arthroplasty (CDA) patient selection in the US is debated, often based on FDA guidelines.
  • Off-label CDA use frequency and extent in the US are largely unknown.
  • International patient selection criteria are less stringent but poorly documented.

Purpose of the Study:

  • Review current US on-label CDA patient selection criteria.
  • Discuss rationale and evidence for expanding CDA criteria in the US.

Main Methods:

  • PubMed literature search using "cervical disc arthroplasty" and "cervical disc replacement."
  • Author evaluation of articles for patient selection criteria.

Main Results:

Keywords:
TDRcervical spine surgeryoff-label spine surgerysurgical indicationstotal disc replacement

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  • Current data do not conclusively show CDA benefits over anterior cervical discectomy and fusion for patients excluded by strict FDA indications.
  • Lack of level 1 evidence supports current CDA patient selection aligning with FDA indications.

    • Conclusions:

    • Expanding CDA indications requires more well-constructed studies, including prospective, controlled trials.
    • Insurance reimbursement for off-label CDA use is unlikely without robust evidence.