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Journal of Orthopaedic Surgery and Research

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Open Access 01-12-2018 | Research article

Clinical experiences with a PEEK-based dynamic instrumentation device in lumbar spinal surgery: 2 years and no more

Authors: Stavros Oikonomidis, Ghazi Ashqar, Thomas Kaulhausen, Christian Herren, Jan Siewe, Rolf Sobottke

Published in: Journal of Orthopaedic Surgery and Research | Issue 1/2018

Abstract

Background

Dynamic spine implants were developed to prevent adjacent segment degeneration (ASD) and adjacent segment disease (ASDi). Purpose of this study was to investigate the clinical and radiological outcomes of “topping off” devices following lumbar spinal fusion procedure using a PEEK-based dynamic rod system. Moreover, this study focused on the hypothesis that “topping off” devices can prevent ASD.

Methods

This prospective nonrandomized study included patients with indication for single-level lumbar fusion and radiological signs of ASD without instability. The exclusion criteria were previous lumbar spine surgery and no sign of disc degeneration in the adjacent segment according to magnetic resonance imaging. All patients were treated with single-level lumbar interbody fusion and dynamic stabilization of the cranial adjacent segment. Patients underwent a clinical examination and radiographs preoperatively and at 1 and 2 years after surgery. Analyses were performed on clinical data collected with the German Spine Registry using the core outcome measure index (COMI) and visual analogue scale (VAS) scores for back and leg pain.

Results

A total of 22 patients (6 male and 16 female) with an average age of 57.6 years were included in the study; 20 patients completed the follow-up (FU). The average COMI score was 9.0 preoperatively, 4.2 at the 1-year FU, and 4.7 at the 2-year FU. The average preoperative VAS scores for back and leg pain were 7.7 and 7.1, respectively. At the 1-year FU, the scores were 4.25 for back pain and 2.2 for leg pain, and at the 2-year FU, the scores were 4.7 for back pain and 2.3 for leg pain. At FU, failure of the dynamic topping off implant material was verified in four cases, and ASD of the segment cranial to the topping off was confirmed in three cases.

Conclusions

These results demonstrate significant improvements in clinical outcomes and pain reduction after lumbar spinal fusion with topping off at 2 years after surgery. However, the implant failed due to the high rate of implant failure and the development of ASD in the segment cranial to the dynamic stabilized segment.

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Title: Clinical experiences with a PEEK-based dynamic instrumentation device in lumbar spinal surgery: 2 years and no more
Authors: Stavros Oikonomidis
Ghazi Ashqar
Thomas Kaulhausen
Christian Herren
Jan Siewe
Rolf Sobottke
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: Journal of Orthopaedic Surgery and Research / Issue 1/2018
Electronic ISSN: 1749-799X
DOI: https://doi.org/10.1186/s13018-018-0905-z

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Clinical experiences with a PEEK-based dynamic instrumentation device in lumbar spinal surgery: 2 years and no more

Abstract

Background

Methods

Results

Conclusions

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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