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Related Experiment Videos

AcroFlex design and results.

Robert D Fraser1, E Raymond Ross, Gary L Lowery

  • 1Department of Orthopaedics and Trauma, Bice Building, Royal Adelaide Hospital, North Terrace, Adelaide 5000, South Australia. rdf@adelaide.on.net

The Spine Journal : Official Journal of the North American Spine Society
|November 16, 2004
PubMed
Summary
This summary is machine-generated.

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The AcroFlex prosthesis, designed for shock absorption, showed successful pilot study outcomes. However, mechanical elastomer failure detected on CT scans halted further trials, raising concerns for its use and other disc arthroplasties.

Area of Science:

  • Biomaterials Science
  • Orthopedic Surgery
  • Medical Device Design

Background:

  • Current disc prostheses aim to improve spinal function and reduce pain.
  • The AcroFlex prosthesis features a unique elastomeric core between titanium endplates for enhanced shock absorption.

Purpose of the Study:

  • To review the design of the AcroFlex Disc.
  • To evaluate the outcomes of two pilot studies involving the AcroFlex prosthesis in 28 patients.

Main Methods:

  • Review of AcroFlex Disc design specifications.
  • Analysis of clinical outcomes from two completed pilot studies.
  • Evaluation of CT scan findings for mechanical integrity.

Main Results:

  • Pilot studies demonstrated successful clinical outcomes in patients receiving the AcroFlex prosthesis.

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  • Mechanical failure of the elastomeric component was detected via thin-cut CT scans.
  • The planned pivotal randomized trial was not initiated due to these findings.

    • Conclusions:

    • While pilot clinical results were promising, the detected mechanical failure poses a significant concern for the AcroFlex prosthesis.
    • The findings necessitate a re-evaluation of the AcroFlex design and elastomer material.
    • Implications extend to the safety and design considerations of other spinal arthroplasties using similar materials.