Evidence map›Paper›PMID 28070681›Full record

Trial reportEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2017

Comparison of the 18-month outcome after the treatment of osteoporotic insufficiency fractures by means of balloon sacroplasty (BSP) and radiofrequency sacroplasty (RFS) in comparison: a prospective randomised study.

Reimer Andresen, Sebastian Radmer, Julian Ramin Andresen, Hans-Christof Schober

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in 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. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. Review
  7. CT-guided cement sacroplasty (CSP) as pain therapy in non-dislocated insufficiency fractures.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2017
    Article
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

4 authors.

Reimer AndresenInstitute of Diagnostic and Interventional Radiology/Neuroradiology, Westkuestenklinikum Heide, Academic Teaching Hospital of the Universities of Kiel, Luebeck and Hamburg, Esmarchstraße 50, 25746, Heide, Germany. randresen@wkk-hei.de.
Sebastian RadmerCentre for Orthopaedics, Berlin, Germany.
Julian Ramin AndresenSigmund Freud University, Vienna, Austria.
Hans-Christof SchoberDepartment of Internal Medicine I, Municipal Hospital Suedstadt Rostock, Academic Teaching Hospital of the University of Rostock, Rostock, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe objective of this prospective, randomised study was to examine the feasibility and clinical outcome of balloon sacroplasty and radiofrequency sacroplasty.

methodsIn 40 patients with a total of 57 sacral fractures, CT-guided cement augmentation was performed by means of BSP or RFS. For BSP, the balloon catheter was inflated and deflated in the fracture zone, and the hollow space, thus, created was then filled with PMMA cement. For RFS, the spongious space in the fracture zone was initially extended using a flexible osteotome, and the highly viscous PMMA cement, activated by radiofrequency, was then inserted into the prepared fracture zone. Pain intensity was determined on a VAS before the intervention, on the second day, and 6, 12 and 18 months after the intervention. The results were tested for significance by means of paired Wilcoxon rank-sum tests and Mann-Whitney U tests.

resultsBSP and RFS were technically fully feasible in all patients. An average of 6.3 ml cement per fracture was inserted in the BSP group and an average of 6.1 ml per fracture in the RFS group. Leakage could be ruled out for both procedures. The mean pain score on the VAS before the intervention was 8.6 ± 0.55 in the BSP group and 8.8 ± 0.58 in the RFS group. On the second postoperative day, a significant pain reduction was seen (p < 0.001), with an average value of 2.5 (BSP ± 0.28, RFS ± 0.38) for both groups. After 6 (12; 18) months, these values were stable for the BSP group at 2.3 ± 0.27 (2.3 ± 0.24; 2.0 ± 0.34) and for the RFS group at 2.4 ± 0.34 (2.2 ± 0.26; 2.0 ± 0.31). With regard to pain, exceedance probability values of p = 0.86 (6 months), p = 0.94 (12 months) and p = 1 (18 months) were seen, so that neither treatment method leads to differences in results.

conclusionsBSP and RFS are interventional, minimally invasive procedures that enable reliable cement augmentation and achieve equally good clinical outcomes in the medium term.

Indexed as

CementoplastyFractures, StressHumansSacrumSpinal FracturesTreatment OutcomeBalloon sacroplastyCement augmentationInsufficiency fracturePain therapyRadiofrequency sacroplastySacrum

Identifiers

PMID28070681

What OpenQuestion holds

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Read underepoch 390

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.