Evidence map›Paper›PMID 30092790›Full record

Observational studyJournal of orthopaedic surgery and research2018

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

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

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in Journal of orthopaedic surgery and research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 29 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Stavros OikonomidisDepartment of Orthopaedics and Trauma Surgery, Rhein-Maas Klinikum GmbH, Mauerfeldchen 25, 52146, Wuerselen, Germany. stavros.oikonomidis@uk-koeln.de.ORCID http://orcid.org/0000-0002-7637-8611
Ghazi AshqarDepartment of Orthopaedics and Trauma Surgery, Rhein-Maas Klinikum GmbH, Mauerfeldchen 25, 52146, Wuerselen, Germany.
Thomas KaulhausenDepartment of Orthopaedics and Trauma Surgery, Rhein-Maas Klinikum GmbH, Mauerfeldchen 25, 52146, Wuerselen, Germany.
Christian HerrenDepartment of Trauma and Reconstructive Surgery, University Hospital RWTH Aachen, Pauwelsstraße 30, 52074, Aachen, Germany.
Jan SieweDepartment of Orthopaedics and Trauma Surgery, University Hospital Cologne, Joseph-Stelzmann-Str. 24, 50931, Cologne, Germany.
Rolf SobottkeDepartment of Orthopaedics and Trauma Surgery, Rhein-Maas Klinikum GmbH, Mauerfeldchen 25, 52146, Wuerselen, Germany.
University Hospital Cologne · DEKlinikum Bielefeld · DERWTH Aachen University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDynamic 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.

methodsThis 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.

resultsA 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.

conclusionsThese 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.

Indexed as

AdultAgedArthroplasty, ReplacementBenzophenonesBiocompatible MaterialsDecompression, SurgicalFemaleFollow-Up StudiesHumansJoint ProsthesisKetonesLaminectomyLigamentum FlavumLumbar VertebraeMaleMiddle AgedBenzophenonesBiocompatible MaterialsKetonespolyetheretherketonePolyethylene GlycolsPolymersSiliconesAdjacent segment diseaseHybrid lumbar instrumentationHybrid posterior fixationMaterial failureTopping off

Identifiers

PMID30092790
PMCPMC6085718
OpenAlexW2887434402

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.