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Patient Safety in Surgery
Published in: Patient Safety in Surgery 1/2017

Open Access 01-12-2017 | Research

Empty polyetheretherketone (PEEK) cages in anterior cervical diskectomy and fusion (ACDF) show slow radiographic fusion that reduces clinical improvement: results from the prospective multicenter “PIERCE-PEEK” study

Authors: Olaf Suess, Martin Schomaker, Mario Cabraja, Marco Danne, Theodoros Kombos, Michael Hanna

Published in: Patient Safety in Surgery | Issue 1/2017

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Abstract

Background

Anterior cervical diskectomy and fusion (ACDF) is a well-established surgical treatment for radiculopathy and myelopathy. Previous studies showed that empty PEEK cages have lower radiographic fusion rates, but the clinical relevance remains unclear. This paper’s aim is to provide high-quality evidence on the outcomes of ACDF with empty PEEK cages and on the relevance of radiographic fusion for clinical outcomes.

Methods

This large prospective multicenter clinical trial performed single-level ACDF with empty PEEK cages on patients with cervical radiculopathy or myelopathy. The main clinical outcomes were VAS (0–10) for pain and NDI (0–100) for functioning. Radiographic fusion was evaluated by two investigators for three different aspects.

Results

The median (range) improvement of the VAS pain score was: 3 (1–6) at 6 months, 3 (2–8) at 12 months, and 4 (2–8) at 18 months. The median (range) improvement of the NDI score was: 12 (2–34) at 6 months, 18 (4–46) at 12 months, and 22 (2–44) at 18 months. Complete radiographic fusion was reached by 126 patients (43%) at 6 months, 214 patients (73%) at 12 months, and 241 patients (83%) at 18 months. Radiographic fusion was a highly significant (p < 0.001) predictor of the improvement of VAS and NDI scores.

Conclusion

This study provides strong evidence that ACDF is effective treatment, but the overall rate of radiographic fusion with empty PEEK cages is slow and insufficient. Lack of complete radiographic fusion leads to less improvement of pain and disability. We recommend against using empty uncoated pure PEEK cages in ACDF.

Trial registration

ISRCTN42774128. Retrospectively registered 14 April 2009.
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Metadata
Title
Empty polyetheretherketone (PEEK) cages in anterior cervical diskectomy and fusion (ACDF) show slow radiographic fusion that reduces clinical improvement: results from the prospective multicenter “PIERCE-PEEK” study
Authors
Olaf Suess
Martin Schomaker
Mario Cabraja
Marco Danne
Theodoros Kombos
Michael Hanna
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Patient Safety in Surgery / Issue 1/2017
Electronic ISSN: 1754-9493
DOI
https://doi.org/10.1186/s13037-017-0128-y

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