Evidence map›Paper›PMID 24568365›Full record

Trial reportBMC musculoskeletal disorders2014

The SNAP trial: a double blind multi-center randomized controlled trial of a silicon nitride versus a PEEK cage in transforaminal lumbar interbody fusion in patients with symptomatic degenerative lumbar disc disorders: study protocol.

Roel F M R Kersten, Steven M van Gaalen, Mark P Arts, Kit C B Roes, Arthur de Gast, Terry P Corbin, F Cumhur Öner

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01557829 (Clinical Study of the Amedica Corporation Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.1field-weighted citation impact, top 14% 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.

NCT01557829 nacompletednot on this map

Clinical Study of the Amedica Corporation Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion

TypeinterventionalSponsorAmedica CorporationRan2012 to 2017Enrolled100ConditionsDisc Degeneration of Pfirrmann Grade III or Greater, Degenerative Spondylolisthesis, Isthmic Spondylolisthesis of Grade I or IIArmsPosterior lumbar interbody fusion with a PEEK cage, Posterior lumbar interbody fusion with a Valeo OL cage
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 45 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Silicon Nitride as a Biomedical Material: An Overview.International journal of molecular sciences · 2022
    Review
  5. Biomaterials for Interbody Fusion in Bone Tissue Engineering.Frontiers in bioengineering and biotechnology · 2022
    Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Advances in Spinal Interbody Cages.Orthopaedic surgery · 2016
    Review
  13. 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

7 authors at 5 institutions in 2 countries.

Roel F M R KerstenClinical Orthopaedic Research Center-midden Nederland (CORC-mN), Department of Orthopaedics, Diakonessenhuis, Utrecht/Zeist, The Netherlands. rkersten@diakhuis.nl.
Steven M van Gaalen
Mark P Arts
Kit C B Roes
Arthur de Gast
Terry P Corbin
F Cumhur Öner
Diakonessenhuis hospital · NLBaptist Health Corbin · USMedisch Centrum Haaglanden · NLUniversity Medical Center Utrecht · NLUtrecht University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPolyetheretherketone (PEEK) cages have been widely used in the treatment of lumbar degenerative disc disorders, and show good clinical results. Still, complications such as subsidence and migration of the cage are frequently seen. A lack of osteointegration and fibrous tissues surrounding PEEK cages are held responsible. Ceramic implants made of silicon nitride show better biocompatible and osteoconductive qualities, and therefore are expected to lower complication rates and allow for better fusion.Purpose of this study is to show that fusion with the silicon nitride cage produces non-inferior results in outcome of the Roland Morris Disability Questionnaire at all follow-up time points as compared to the same procedure with PEEK cages. METHODS/

designThis study is designed as a double blind multi-center randomized controlled trial with repeated measures analysis. 100 patients (18-75 years) presenting with symptomatic lumbar degenerative disorders unresponsive to at least 6 months of conservative treatment are included. Patients will be randomly assigned to a PEEK cage or a silicon nitride cage, and will undergo a transforaminal lumbar interbody fusion with pedicle screw fixation. Primary outcome measure is the functional improvement measured by the Roland Morris Disability Questionnaire. Secondary outcome parameters are the VAS leg, VAS back, SF-36, Likert scale, neurological outcome and radiographic assessment of fusion. After 1 year the fusion rate will be measured by radiograms and CT. Follow-up will be continued for 2 years. Patients and clinical observers who will perform the follow-up visits will be blinded for type of cage used during follow-up. Analyses of radiograms and CT will be performed independently by two experienced radiologists. DISCUSSION: In this study a PEEK cage will be compared with a silicon nitride cage in the treatment of symptomatic degenerative lumbar disc disorders. To our knowledge, this is the first randomized controlled trial in which the silicon nitride cage is compared with the PEEK cage in patients with symptomatic degenerative lumbar disc disorders.

trial registrationNCT01557829.

Indexed as

Biocompatible MaterialsInternal FixatorsKetonesPolyethylene GlycolsSilicon CompoundsAdolescentAdultAgedBenzophenonesClinical ProtocolsDouble-Blind MethodFollow-Up StudiesHumansIntervertebral Disc DegenerationLow Back PainLumbar VertebraeBenzophenonesBiocompatible MaterialsKetonespolyetheretherketonePolyethylene GlycolsPolymersSilicon Compoundssilicon nitride

Identifiers

PMID24568365
PMCPMC3937453
OpenAlexW2088908987

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.