Evidence map›Paper›PMID 30834972›Full record

Trial reportEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2019

Evaluation of an increased strut porosity silicate-substituted calcium phosphate, SiCaP EP, as a synthetic bone graft substitute in spinal fusion surgery: a prospective, open-label study.

Ciaran Bolger, Drew Jones, Steven Czop

Registry-linked trialOpen access · hybridAbstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01452022 (A Prospective Open-label Non-randomdised Multi-centre Clinical Study to Evaluate the Performance of Inductigraft in Posterolateral Fusion), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 29% 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.

NCT01452022 nacompletednot on this map

A Prospective Open-label Non-randomdised Multi-centre Clinical Study to Evaluate the Performance of Inductigraft in Posterolateral Fusion

TypeinterventionalSponsorBaxter Healthcare CorporationRan2011 to 2015Enrolled125ConditionsDegenerative Disk Disease, Spinal Stenosis of Lumbar RegionArmsInductigraft
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Ceramic Biologics for Bony Fusion-a Journey from First to Third Generations.Current reviews in musculoskeletal medicine · 2020
    Review
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

3 authors at 2 institutions in 2 countries.

Ciaran BolgerBeaumont Hospital, PO Box 1297, Beaumont Road, Dublin 9, Republic of Ireland. cbolger007@icloud.com.
Drew JonesBeaumont Hospital, PO Box 1297, Beaumont Road, Dublin 9, Republic of Ireland.
Steven CzopBaxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL, 60015, USA.
Beaumont Hospital · IEBaxter (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSilicate-substituted calcium phosphate-enhanced porosity (SiCaP EP, Inductigraft™, Altapore) is a synthetic bone graft material with enhanced strut porosity of 31-47%. SiCaP EP remains to be fully clinically evaluated in patients undergoing instrumented posterolateral fusion (PLF) surgery. We conducted a prospective, open-label, non-randomised, multicentre clinical study to evaluate efficacy of SiCaP EP as bone grafting material in PLF surgery with instrumentation for treatment of spinal disorders.

methodsPatients with degenerative disc disease, spondylolisthesis or spinal stenosis underwent PLF surgery with SiCaP EP. The primary endpoint was evaluated in the per protocol population (N = 102) as solid fusion at postoperative month 12 assessed using computed tomography scans, with motion assessed using flexion-extension radiographs. Clinical outcomes included the Oswestry Disability Index, 36-item short-form health survey for quality-of-life, visual analog scale for pain scores and neurological assessments. Adverse events were recorded.

resultsSuccessful fusion was achieved in 59/89 (66.3%) patients at month 6, 88/102 patients (86.3%) at month 12 (primary endpoint) and 87/96 (90.6%) patients at month 24. Disability and pain reduced following surgery. Quality-of-life improved and neurological function was maintained postoperatively. Forty-three (33.3%) of the 129 patients who underwent surgery experienced adverse events; back pain was most frequent (n = 10); nine and 14 patients experienced serious adverse events judged related to device and procedure, respectively.

conclusionsEnhanced strut porosity SiCaP EP provided high (month 12: 86.3%) spinal fusion success rates in PLF surgery. Fusion success was associated with improved clinical outcomes in patients within 12 months, relative to baseline. CLINICALTRIALS. GOV IDENTIFIER: NCT01452022 These slides can be retrieved under Electronic Supplementary Material.

Indexed as

Bone SubstitutesCalcium PhosphatesSilicatesAdolescentAdultAgedAged, 80 and overFemaleFollow-Up StudiesHumansMaleMiddle AgedPorosityProspective StudiesSpinal DiseasesSpinal FusionBone Substitutescalcium phosphateCalcium PhosphatesSilicatesDegenerative disc diseasePorosityPosterolateral fusionSilicate-substituted calcium phosphateSpinal fusion

Identifiers

PMID30834972
OpenAlexW2920232524

What OpenQuestion holds

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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.