Evidence map›Paper›PMID 32459724›Full record

Trial reportSpine2020

Increasing Fusion Rate Between 1 and 2 Years After Instrumented Posterolateral Spinal Fusion and the Role of Bone Grafting.

A Mechteld Lehr, F Cumhur Oner, Diyar Delawi, Rebecca K Stellato, Eric A Hoebink, Diederik H R Kempen, Job L C van Susante, René M Castelein, Moyo C Kruyt, Dutch Clinical Spine Research Group

Open access · hybridAbstract readEquivalence TrialMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Spine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Ceramic bone graft substitute vs autograft in XLIF: a prospective randomized single-center evaluation of radiographic and clinical outcomes.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 · 2022
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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

10 authors at 5 institutions in 1 country.

A Mechteld LehrDepartment of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
F Cumhur OnerDepartment of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Diyar DelawiDepartment of Orthopaedic Surgery, St. Antonius Hospital, Utrecht, The Netherlands.
Rebecca K StellatoJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Eric A HoebinkDepartment of Orthopaedic Surgery, Amphia Hospital, Breda, The Netherlands.
Diederik H R KempenDepartment of Orthopaedic Surgery, OLVG, Amsterdam, The Netherlands.
Job L C van SusanteDepartment of Orthopaedic Surgery, Rijnstate Hospital, Arnhem, The Netherlands.
René M CasteleinDepartment of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Moyo C KruytDepartment of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Dutch Clinical Spine Research Group
University Medical Center Utrecht · NLAmphia Ziekenhuis · NLOLVG · NLRijnstate Hospital · NLSt. Antonius Ziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designTwo-year clinical and radiographic follow-up of a double-blind, multicenter, randomized, intra-patient controlled, non-inferiority trial comparing a bone graft substitute (AttraX Putty) with autograft in instrumented posterolateral fusion (PLF) surgery.

objectivesThe aim of this study was to compare PLF rates between 1 and 2 years of follow-up and between graft types, and to explore the role of bone grafting based on the location of the PLF mass. SUMMARY OF BACKGROUND DATA: There are indications that bony fusion proceeds over time, but it is unknown to what extent this can be related to bone grafting.

methodsA total of 100 adult patients underwent a primary, single- or multilevel, thoracolumbar PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX Putty was disclosed. The contralateral posterolateral gutters were grafted with autograft. At 1-year follow-up, and in case of no fusion at 2 years, the fusion status of both sides of each segment was blindly assessed on CT scans. Intertransverse and facet fusion were scored separately. Difference in fusion rates after 1 and 2 years and between grafts were analyzed with a Generalized Estimating Equations (GEE) model (P < 0.05).

resultsThe 2-year PLF rate (66 patients) was 70% at the AttraX Putty and 68% at the autograft side, compared to 55% and 52% after 1 year (87 patients). GEE analysis demonstrated a significant increase for both conditions (odds ratio 2.0, 95% confidence interval 1.5-2.7, P < 0.001), but no difference between the grafts (P = 0.595). Ongoing bone formation was only observed between the facet joints.

conclusionThis intra-patient controlled trial demonstrated a significant increase in PLF rate between 1 and 2 years after instrumented thoracolumbar fusion, but no difference between AttraX Putty and autograft. Based on the location of the PLF mass, this increase is most likely the result of immobilization instead of grafting. LEVEL OF EVIDENCE: 1.

Indexed as

Bone TransplantationSpinal FusionAdultBone SubstitutesDouble-Blind MethodFemaleHumansLumbar VertebraeMaleMiddle AgedRoleTransplantation, AutologousTreatment OutcomeBone Substitutes

Identifiers

PMID32459724
PMCPMC7515483
OpenAlexW3030934230

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.