Evidence map›Paper›PMID 29063215›Full record

ArticleOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2018

Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials?

K L Ong, D P Beall, M Frohbergh, E Lau, J A Hirsch

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Article in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 42 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 4 pooled it
–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.

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

42 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Kyphoplasty is associated with reduced mortality risk for osteoporotic vertebral compression fractures: a systematic review and 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 · 2024
    Pooled it
  4. Percutaneous cement augmentation in the treatment of osteoporotic vertebral fractures (OVFs) in the elderly: a systematic review.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. Trial
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Real-world rates and risk factors for subsequent treatment with vertebroplasty or balloon kyphoplasty after initial vertebral augmentation: a retrospective cohort study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
    Article
  12. Fractures of the thoracolumbar spine in osteoporosis.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2024
    Review
  13. Article
  14. ESTES recommendation on thoracolumbar spine fractures : January 2023.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2024
    Review
  15. Health Care Fraud and Abuse: Lessons From One of the Largest Scandals of the 21st Century in the Field of Spine Surgery.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2024
    Article
  16. Article
  17. Article
  18. Article
  19. Vertebral augmentation: an overview.Skeletal radiology · 2023
    Review
  20. Mortality among older adults with osteoporotic vertebral fracture.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2023
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

K L OngExponent, Inc., 3440 Market St, Suite 600, Philadelphia, PA, USA. kong@exponent.com.
D P BeallOklahoma Spine, Edmond, OK, USA.
M FrohberghExponent, Inc., 3440 Market St, Suite 600, Philadelphia, PA, USA.
E LauExponent, Inc., Menlo Park, CA, USA.
J A HirschMassachusetts General Hospital, Boston, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The 5-year period following 2009 saw a steep reduction in vertebral augmentation volume and was associated with elevated mortality risk in vertebral compression fracture (VCF) patients. The risk of mortality following a VCF diagnosis was 85.1% at 10 years and was found to be lower for balloon kyphoplasty (BKP) and vertebroplasty (VP) patients.

introductionBKP and VP are associated with lower mortality risks than non-surgical management (NSM) of VCF. VP versus sham trials published in 2009 sparked controversy over its effectiveness, leading to diminished referral volumes. We hypothesized that lower BKP/VP utilization would lead to a greater mortality risk for VCF patients.

methodsBKP/VP utilization was evaluated for VCF patients in the 100% US Medicare data set (2005-2014). Survival and morbidity were analyzed by the Kaplan-Meier method and compared between NSM, BKP, and VP using Cox regression with adjustment by propensity score and various factors.

resultsThe cohort included 261,756 BKP (12.6%) and 117,232 VP (5.6%) patients, comprising 20% of the VCF patient population in 2005, peaking at 24% in 2007-2008, and declining to 14% in 2014. The propensity-adjusted mortality risk for VCF patients was 4% (95% CI, 3-4%; p < 0.001) greater in 2010-2014 versus 2005-2009. The 10-year risk of mortality for the overall cohort was 85.1%. BKP and VP cohorts had a 19% (95% CI, 19-19%; p < 0.001) and 7% (95% CI, 7-8%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the NSM cohort, respectively. The BKP cohort had a 13% (95% CI, 12-13%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the VP cohort.

conclusionsChanges in treatment patterns following the 2009 VP publications led to fewer augmentation procedures. In turn, the 5-year period following 2009 was associated with elevated mortality risk in VCF patients. This provides insight into the implications of treatment pattern changes and associated mortality risks.

Indexed as

AgedAged, 80 and overAttitude of Health PersonnelComorbidityFemaleFractures, CompressionHumansKaplan-Meier EstimateKyphoplastyLength of StayMaleMedicareMortalityOsteoporotic FracturesRandomized Controlled Trials as TopicResearch DesignBalloon kyphoplastyMortalityVertebral augmentationVertebral compression fractureVertebroplasty

Identifiers

PMID29063215
PMCPMC6394540

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Registered trials

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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.