Evidence map›Paper›PMID 25300981›Full record

Trial reportAJNR. American journal of neuroradiology2014

A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis.

M Dohm, C M Black, A Dacre, J B Tillman, G Fueredi, KAVIAR investigators

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in AJNR. American journal of neuroradiology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03580434 (National, Multicentre, Pilot Study, to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System Indicated for Vertebral Compression Fracture Treatment), which is not on this map. Cited by 78 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 7 pooled it
12.9field-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.

NCT03580434 nacompletednot on this mapstarted 2019, after this paper: background citation

National, Multicentre, Pilot Study, to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System Indicated for Vertebral Compression Fracture Treatment

TypeinterventionalSponsorHypreventionRan2019 to 2022Enrolled9ConditionsVertebral Compression FractureArmsV-STRUT
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 7 syntheses or guidelines pooled it, 172 citations in OpenAlex.

  1. Pooled it
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  5. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.The Cochrane database of systematic reviews · 2018
    Pooled it
  6. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.The Cochrane database of systematic reviews · 2018
    Pooled it
  7. Pooled it
  8. Percutaneous vertebroplasty and balloon kyphoplasty in the treatment of osteoporotic vertebral fractures: a prospective randomized comparison.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
    Trial
  9. Long-term safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019
    Trial
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18 more citing papers are in PubMed but not listed here.

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

6 authors at 3 institutions in 1 country.

M DohmFrom the Department of Orthopaedic Surgery, University of Arizona College of Medicine (M.D.), Tucson, Arizona mdohm@ortho.arizona.edu.
C M BlackUtah Valley Interventional Associates and Utah Valley Regional Medical Center (C.M.B.), Provo, Utah.
A DacreOrthoMontana (A.D.), Billings, Montana.
J B TillmanMedtronic Spine (J.B.T.), Sunnyvale, California.
G FuerediAurora Memorial Hospital of Burlington (G.F.), Burlington, Wisconsin.
KAVIAR investigators
Medtronic (United States) · USUniversity of Arizona · USUtah Valley Regional Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeSeveral trials have compared vertebral augmentation with nonsurgical treatment for vertebral compression fractures. This trial compares the efficacy and safety of balloon kyphoplasty and vertebroplasty. MATERIALS AND

methodsPatients with osteoporosis with 1-3 acute fractures (T5-L5) were randomized and treated with kyphoplasty (n = 191) or vertebroplasty (n = 190) and were not blinded to the treatment assignment. Twelve- and 24-month subsequent radiographic fracture incidence was the primary end point. Due to low enrollment and early withdrawals, the study was terminated with 404/1234 (32.7%) patients enrolled.

resultsThe average age of patients was 75.6 years (77.4% female). Mean procedure duration was longer for kyphoplasty (40.0 versus 31.8 minutes, P < .001). At 12 months, 7.8% fewer patients with kyphoplasty (50/140 versus 57/131) had subsequent radiographic fracture, and there were 8.6% fewer at 24 months (54/110 versus 64/111). The results were not statistically significant (P > .21). When we used time to event for new clinical fractures, kyphoplasty approached statistical significance in longer fracture-free survival (Wilcoxon, P = .0596). Similar pain and function improvements were observed. CT demonstrated lower cement extravasation for kyphoplasty (157/214 versus 164/201 levels treated, P = .047). For kyphoplasty versus vertebroplasty, common adverse events within 30 postoperative days were procedural pain (12/191, 9/190), back pain (14/191, 28/190), and new vertebral fractures (9/191, 17/190); similar 2-year occurrence of device-related cement embolism (1/191, 1/190), procedural pain (3/191, 3/190), back pain (2/191, 3/190), and new vertebral fracture (2/191, 2/190) was observed.

conclusionsKyphoplasty and vertebroplasty had similar long-term improvement in pain and disability with similar safety profiles and few device-related complications. Procedure duration was shorter with vertebroplasty. Kyphoplasty had fewer cement leakages and a trend toward longer fracture-free survival.

Indexed as

AdultAgedAged, 80 and overBone CementsFemaleFractures, CompressionHumansKyphoplastyMaleMiddle AgedOperative TimeOsteoporotic FracturesSpinal FracturesTreatment OutcomeVertebroplastyBone Cements

Identifiers

PMID25300981
PMCPMC7965303
OpenAlexW2143000612

What OpenQuestion holds

Textmetadata
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.