Evidence map›Paper›PMID 23778905›Full record

SynthesisAnnals of internal medicine2013

Safety and effectiveness of recombinant human bone morphogenetic protein-2 for spinal fusion: a meta-analysis of individual-participant data.

Mark C Simmonds, Jennifer V E Brown, Morag K Heirs, Julian P T Higgins, Richard J Mannion, Mark A Rodgers, Lesley A Stewart

Abstract readMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in Annals of internal medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 157 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
157citing papers in PubMed, 11 pooled it
32.9field-weighted citation impact, top 1% 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

157 citing papers in PubMed, 11 syntheses or guidelines pooled it, 328 citations in OpenAlex.

  1. Pooled it
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  4. Efficacy and safety of bone substitutes in lumbar spinal fusion: a systematic review and network meta-analysis of randomized controlled trials.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 · 2020
    Pooled it
  5. Bone morphogenetic protein in adult spinal deformity surgery: a meta-analysis.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 · 2017
    Pooled it
  6. Pooled it
  7. Platelet concentrates in spine fusion: meta-analysis of union rates and complications in controlled trials.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 · 2016
    Pooled it
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  9. Cochrane in CORR1: Steroids for Acute Spinal Cord Injury (Review).Clinical orthopaedics and related research · 2016
    Pooled it
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  12. Trial
  13. Review
  14. Recombinant bone morphogenetic protein-2 attenuates colorectal cancer progression by orchestrating Hippo pathway activation, Yes-associated protein inhibition, and epithelial-mesenchymal transition suppression.The Korean journal of physiology & pharmacology : official journal of the Korean Physiological Society and the Korean Society of Pharmacology · 2026
    Article
  15. Review
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  20. Article

97 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Mark C SimmondsCentre for Reviews and Dissemination, University of York, York, United Kingdom.
Jennifer V E Brown
Morag K Heirs
Julian P T Higgins
Richard J Mannion
Mark A Rodgers
Lesley A Stewart
University of York · GB

Funding

Medical Research Council MC_U105285807
6 · The paper itself

Abstract

backgroundRecombinant human bone morphogenetic protein-2 (rhBMP-2) is widely used to promote fusion in spinal surgery, but its safety has been questioned. PURPOSE: To evaluate the effectiveness and safety of rhBMP-2. DATA SOURCES: Individual-participant data obtained from the sponsor or investigators and data extracted from study publications identified by systematic bibliographic searches through June 2012. STUDY SELECTION: Randomized, controlled trials of rhBMP-2 versus iliac crest bone graft (ICBG) in spinal fusion surgery for degenerative disc disease and related conditions and observational studies in similar populations for investigation of adverse events. DATA EXTRACTION: Individual-participant data from 11 eligible of 17 provided trials sponsored by Medtronic (Minneapolis, Minnesota) (n = 1302) and 1 of 2 other eligible trials (n = 106) were included. Additional aggregate adverse event data were extracted from 35 published observational studies. DATA SYNTHESIS: Primary outcomes were pain (assessed with the Oswestry Disability Index [ODI] or Short Form-36), fusion, and adverse events. At 24 months, ODI scores were 3.5% lower (better) with rhBMP-2 than with ICBG (95% CI, 0.5% to 6.5%) and radiographic fusion was 12% higher (CI, 2% to 23%). At or shortly after surgery, pain was more common with rhBMP-2 (odds ratio, 1.78 [CI, 1.06 to 2.95]). Cancer was more common after rhBMP-2 (relative risk, 1.98 [CI, 0.86 to 4.54]), but the small number of events precluded definite conclusions. LIMITATION: The observational studies were diverse and at risk of bias.

conclusionAt 24 months, rhBMP-2 increases fusion rates, reduces pain by a clinically insignificant amount, and increases early postsurgical pain compared with ICBG. Evidence of increased cancer incidence is inconclusive. PRIMARY FUNDING SOURCE: Yale University Open Data Access Project.

Indexed as

Spinal FusionBone Morphogenetic Protein 2Disability EvaluationHumansIliumIncidenceIntervertebral Disc DegenerationNeoplasmsPostoperative PainRecombinant ProteinsTime FactorsTransforming Growth Factor betaTreatment OutcomeBone Morphogenetic Protein 2recombinant human bone morphogenetic protein-2Recombinant ProteinsTransforming Growth Factor beta

Identifiers

PMID23778905
OpenAlexW2159404520

What OpenQuestion holds

Textmetadata
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.