Evidence map›Paper›PMID 23696683›Full record

Trial reportRadiology2013

Investigational vertebroplasty safety and efficacy trial (INVEST): patient-reported outcomes through 1 year.

Bryan A Comstock, Colleen M Sitlani, Jeffrey G Jarvik, Patrick J Heagerty, Judith A Turner, David F Kallmes

3 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Radiology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 26 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 5 pooled it
3.8field-weighted citation impact, top 7% 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.

NCT00068822 phase3completednot on this map

Investigational Vertebroplasty Efficacy and Safety Trial (INVEST)

TypeinterventionalSponsorMayo ClinicRan2003 to 2009Enrolled131ConditionsSpinal Fractures, OsteoporosisArmsPercutaneous vertebroplasty, Sham vertebroplasty
NCT02370628 naterminatednot on this mapstarted 2015, after this paper: background citation

Vertebroplasty In The Treatment Of Acute Fracture Trial (The VITTA Trial)

TypeinterventionalSponsorCentre hospitalier de l'Université de Montréal (CHUM)Ran2015 to 2018Enrolled2ConditionsVertebral Compression FracturesArmsPercutaneous vertebroplasty, Facet block
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

26 citing papers in PubMed, 5 syntheses or guidelines pooled it, 60 citations in OpenAlex.

  1. Pooled it
  2. 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
  3. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.The Cochrane database of systematic reviews · 2018
    Pooled it
  5. Pooled it
  6. Review
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  16. ARthroscopy in Knee OsteoArthritis (ARK-OA): a multicentre study assessing compliance to national guidelines.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2021
    Article
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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

6 authors at 3 institutions in 1 country.

Bryan A ComstockDepartments of Biostatistics, Pediatrics, Medicine, and Psychiatry and Behavioral Science, University of Washington, 4333 Brooklyn Ave NE, Box 359461, Seattle, WA 98195-9461; Department of Radiology, Harborview Medical Center, Seattle, Wash.
Colleen M Sitlani
Jeffrey G Jarvik
Patrick J Heagerty
Judith A Turner
David F Kallmes
University of Washington · USHarborview Medical Center · USMayo Clinic in Arizona · US

Funding

SHAM-CONTROLLED TRIAL OF PERCUTANEOUS VERTEBROPLASTYR01AR049373 · NIAMS · MAYO CLINIC ROCHESTER · PI KALLMES, DAVID F · 2002 to 2008
$1.8M
NIAMS NIH HHS R01 AR049373NIAMS NIH HHS R01-AR49373
6 · The paper itself

Abstract

purposeTo evaluate 1-year outcomes of the Investigational Vertebroplasty Safety and Efficacy Trial (INVEST), a blinded, randomized, controlled trial to investigate the effectiveness of percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures. MATERIALS AND

methodsPatients were enrolled at 11 sites in the United States, the United Kingdom, and Australia by using an institutional review board-approved protocol and HIPAA compliance, and all patients provided written informed consent. Patients were randomized to undergo vertebroplasty or a control procedure. After 1 month, patients were allowed to cross over and undergo the alternate procedure. Coprimary outcomes were patient-reported function, measured with the modified Roland-Morris Disability Questionnaire (RDQ), and pain (on a scale of one to 10) at 1 year. Intention-to-treat (ITT) and as-treated (AT) analyses were used to compare outcomes.

resultsOne hundred thirty-one participants (68 in the vertebroplasty group and 63 in the control group) were included in the analyses. Patients in both groups showed improvements in pain and function at 1 year. In ITT analyses, patients randomized to vertebroplasty did not differ from control subjects in terms of RDQ results (difference, 1.37 points; 95% confidence interval [CI]: -0.88, 3.62; P = .231) but reported lower levels of pain (difference, 1.02 points; 95% CI: 0.04, 2.01; P = .042). Eleven of 68 patients who underwent vertebroplasty (16%) and 38 of 63 control subjects (60%) crossed over and elected to undergo the alternate procedure (P < .001). In AT analyses, patients treated with vertebroplasty did not differ from control subjects in terms of RDQ results (difference, 0.66 points; 95% CI: -1.98, 3.30; P = .625) or pain (difference, 0.85 points; 95% CI: -0.35, 2.05; P = .166).

conclusionVertebroplasty may provide a modest reduction in pain at 1 year compared with a control procedure; however, no difference in functional disability was observed. Clinical trial registration no. NCT00068822.

Indexed as

AdultAgedComorbidityDiagnostic Self EvaluationDouble-Blind MethodFemaleHumansLongitudinal StudiesMaleMiddle AgedPatient SatisfactionPostoperative ComplicationsPrevalenceRecovery of FunctionRisk FactorsSpinal Fractures

Identifiers

PMID23696683
PMCPMC3781356
OpenAlexW2123290729

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.