Evidence map›Paper›PMID 40050812›Full record

Observational studyBMC musculoskeletal disorders2025

Lumbar fusion using a carbon-fiber PEEK pedicle screw system combined with a carbon-fiber PEEK TLIF cage: a prospective, multicenter study.

Marcus Eif, Thomas Forster, Christoph Fleege, Francis Kilian, Anne Dorothée Schmitt, Dorothea Daentzer

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMC musculoskeletal disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02087267 (Lumbar Fusion With The Icotec CF/PEEK Pedicle System In Combination With The Icotec CF/PEEK TLIF Cage ETurn™), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT02087267 completednot on this map

Lumbar Fusion With The Icotec CF/PEEK Pedicle System In Combination With The Icotec CF/PEEK TLIF Cage ETurn™

TypeobservationalSponsorSitona AGRan2014 to 2022Enrolled94ConditionsDegeneration of Lumbar Intervertebral Disc, Degenerative SpondylolisthesisArms1- or 2-level spinal fusion
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
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.

Marcus EifStädtisches Klinikum Görlitz gGmbH, Klinik für Neurochirurgie, Girbigsdorfer Straße 1-3, 02828, Görlitz, Germany.
Thomas ForsterKantonsspital St. Gallen, Ostschweizer Wirbelsäulenzentrum, Rorschacher Strasse 95, St. Gallen, 9007, Switzerland.
Christoph FleegeOrthopädische Universitätsklinik Friedrichsheim gGmbH, Marienburgstrasse 2, 60528, Frankfurt am Main, Germany.
Francis KilianKatholisches Klinikum Brüderhaus Koblenz, Klinik für Wirbelsäulenchirurgie, Kardinal- Krementz-Str. 1-5, 56073, Koblenz, Germany.
Anne Dorothée SchmittKlinik für Neurochirurgie, UK S-H, Campus Kiel, Arnold-Heller-Str. 3, Haus 41, 24105, Kiel, Germany.
Dorothea DaentzerOrthopedic Department, Spine Section, Hannover Medical School, DIAKOVERE Annastift, Anna-von-Borries-Str. 1-7, 30625, Hannover, Germany. dorothea.daentzer@diakovere.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCarbon-fiber-reinforced polyether ether ketone (CF-PEEK) is a radiolucent, non-metallic implant material used for instrumented lumbar spondylodesis. Clinical studies of pedicle screw systems employing this material, especially for degenerative indications, are scant.

methodsWe conducted a multicenter, prospective clinical study to assess clinical and radiographic outcomes in patients with symptomatic degenerative lumbar disk disease, including degenerative spondylolisthesis treated with a CF-PEEK pedicle screw and a transforaminal lumbar interbody fusion (TLIF) cage system. We followed up the participants for two years postoperatively to collect clinical data (via the Oswestry Disability Index, Core Outcome Measures Index, and Visual Analog Scale), radiographic parameters (functional X-rays) to assess fusion status, and any complications.

resultsIn total, 86 patients were recruited. During the study, 21 patients (24.4%) dropped out, including 5 (5.8%) who underwent explantation of the study device(s). At the final follow-up, the fusion rate was 98.6% (95% confidence interval, 92.7-100.0%). All clinical parameters improved significantly. There were no complications potentially attributed to the implant material.

conclusionsThe results demonstrate a fusion rate similar to that of metallic implant systems with the use of a CF-PEEK pedicle screw and a TLIF cage system. Further studies with larger samples are needed to substantiate this finding.

trial registrationThe study was registered at ClinicalTrials.gov (NCT02087267). Date of registration: March 12, 2014.

Indexed as

CarbonIntervertebral Disc DegenerationKetonesLumbar VertebraePedicle ScrewsPolyethylene GlycolsSpinal FusionSpondylolisthesisAdultAgedBenzophenonesCarbon FiberFemaleFollow-Up StudiesHumansMaleBenzophenonesCarbonCarbon FiberKetonespolyetheretherketonePolyethylene GlycolsPolymersCarbon fiberCFR-PEEKDegenerative disc diseasePedicle screwSpine fusionSpondylolisthesis

Identifiers

PMID40050812
PMCPMC11883982

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Registered trials

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.