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Evaluation of pain reduction and height restoration post vertebral augmentation using a polyether ether ketone (PEEK) polymer implant for the treatment of split (Magerl A2) vertebral fractures: a prospective, long-term, non-randomized study

  • Interventional
  • Published:
European Radiology Aims and scope Submit manuscript

Abstract

Objectives

The purposes of the study were to evaluate the safety and long-term efficacy of augmented vertebroplasty using a polyether ether ketone (PEEK) implant, for the treatment of lumbar or thoracic vertebral fractures (A2 according to the Magerl’s AO classification) and to analyze pain reduction, height restoration, and complications during a 2-year follow-up period.

Methods

Prospective non-randomized evaluation was performed for 21 painful split vertebral fractures (20 patients, 14 females, 6 males; mean age 72.80 ± 10.991) treated with percutaneous vertebral augmentation using a PEEK device, under fluoroscopic guidance. Pain before the procedure and after 6, 12, and 24 months was evaluated using a numeric visual scale (NVS) questionnaire. Imaging was performed by CT and X-rays. The minimum craniocaudal diameter at the level of the fracture and the maximum craniocaudal diameter at the middle of the fractured vertebra were measured. Statistical analysis was performed to evaluate pain decrease and height restoration.

Results

Successful implant positioning was achieved in all cases. No major clinical complications were observed. Comparing the mean pain scores at baseline (8.69 ± 1.138) and the first day after the treatment (1.19 ± 1.424), there was a decrease of 7.50 NVS units (p < 0.001). Minimum and maximum vertebral body heights were increased after the procedure 56.58% and 13.7% respectively (p < 0.001). Both pain relief and height restoration remained statistically significant (p < 0.001) during the follow-up period.

Conclusion

A2 Magerl thoracic or lumbar fractures could be successfully treated with PEEK implant-assisted vertebral augmentation. Randomized studies with larger sample sizes should be done to confirm the effectiveness of the technique.

Key Points

• Vertebral augmentation using a PEEK implant for the treatment of A2 Magerl lumbar or thoracic vertebral fractures seems to be effective both in terms of pain reduction and height restoration.

• Effects on pain reduction and height restoration have a long-term duration.

• The technique seems to be safe for the treatment of A2 Magerl fractures, without major complications in our study group.

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Abbreviations

NVS:

Numeric visual scale

PEEK:

Polyether ether ketone

PMMA:

Polymethylmethacrylate

STIR:

Short-TI inversion recovery

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Funding

The authors state that this work has not received any funding.

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Authors and Affiliations

  1. 2nd Department of Radiology, Attikon General University Hospital, National and Kapodistrian University of Athens, Rimini 1, Haidari, 12462, Athens, Greece

    Georgios Velonakis, Dimitrios Filippiadis, Stavros Spiliopoulos, Elias Brountzos, Nikolaos Kelekis & Alexis Kelekis

Authors
  1. Georgios Velonakis
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  2. Dimitrios Filippiadis
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  3. Stavros Spiliopoulos
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  4. Elias Brountzos
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  5. Nikolaos Kelekis
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  6. Alexis Kelekis
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Corresponding author

Correspondence to Georgios Velonakis.

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Guarantor

The scientific guarantor of this publication is Alexios Kelekis.

Conflict of interest

The authors of this manuscript declare no relationships with any companies whose products or services may be related to the subject matter of the article.

Statistics and biometry

No complex statistical methods were necessary for this paper. One of the authors has significant statistical expertise.

Informed consent

Written informed consent was obtained from all subjects (patients) in this study.

Ethical approval

Institutional review board approval was obtained.

Methodology

• Prospective

• Observational

• Performed at one institution

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Velonakis, G., Filippiadis, D., Spiliopoulos, S. et al. Evaluation of pain reduction and height restoration post vertebral augmentation using a polyether ether ketone (PEEK) polymer implant for the treatment of split (Magerl A2) vertebral fractures: a prospective, long-term, non-randomized study. Eur Radiol 29, 4050–4057 (2019). https://doi.org/10.1007/s00330-018-5867-3

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  • DOI: https://doi.org/10.1007/s00330-018-5867-3

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