Evidence map›Paper›PMID 26482590›Full record

Trial reportEuropean journal of orthopaedic surgery & traumatology : orthopedie traumatologie2016

Clinical comparison of postoperative results of balloon kyphoplasty (BKP) versus radiofrequency-targeted vertebral augmentation (RF-TVA): a prospective clinical study.

A Petersen, E Hartwig, E M W Koch, M Wollny

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of orthopaedic surgery & traumatology : orthopedie traumatologie, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07665424 (The Clinical Investigation to Evaluate the Safety and Efficacy of Vessel-X® Bone Filling Container System), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 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.

NCT07665424 narecruitingnot on this mapstarted 2021, after this paper: background citation

The Clinical Investigation to Evaluate the Safety and Efficacy of Vessel-X® Bone Filling Container System

TypeinterventionalSponsorJuin-Hong CherngRan2021 to 2026Enrolled146ConditionsOsteoporosis, Osteoporotic Vertebral Compression FracturesArmsCMT Vessel-X® Bone Filling Container System, CMT Manual Orthopedic Surgical Instruments
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. 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.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
    Trial
  4. Review
  5. Article
  6. Article
  7. [Spinal fractures].Zeitschrift fur Gerontologie und Geriatrie · 2016
    Review
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.

A Petersen
E Hartwig
E M W Koch
M Wollny

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOsteoporotic vertebral fractures are a frequent occurrence in geriatric traumatology. Differences in the achievement of pain reduction and restoration of the height of the vertebral body after balloon kyphoplasty (BKP) or radiofrequency-targeted vertebral augmentation (RF-TVA) were to be tested on a randomized population.

methodsA total of 80 patients (f = 59; m = 21) with osteoporotic fractures of vertebral bodies were assigned to the groups BKP (n = 44) or RF-TVA (n = 36). The clinical analyses were compared peri- and postoperatively in a prospective study with an additional follow-up examination after 1 year.

resultsThe operations for BKP were bipedicular in all cases; for RF-TVA, a bipedicular access was required in only five cases (14 %) (p>0.0001). There were confirmed differences with respect to the amount of cement used (ml) between the two groups (BKP = 4.9 ± 1 vs. RFTVA= 3.4 ± 1; p<0.001). In the BKP group, the angle of kyphosis was reduced by an average of 1.65° and in the RF-TVA group by an average of 2.8° by the operation. The analysis of the maximum VAS data showed a clear postoperative reduction in the intensity of pain of approximately 4.5 cm in each of the groups with no discernible difference. After 12 months, the majority of patients in both groups (BKP = 61 % vs. RF-TVA = 83 %) reported being free of pain when at rest without a significant difference(p = 0.05).

conclusionsA certain superiority of RF-TVA with respect to pain relief, amount of cement required, savings of operating time and personnel, and greater safety with respect to cement leakage noted in this study are consistent with other published literature. The differences between the two methods in the frequency of subsequent postoperative fractures and the secondary loss of high restoration were encouraging regarding RF-TVA.

Indexed as

AgedAged, 80 and overBack PainCatheter AblationFemaleFractures, CompressionHumansKyphoplastyMaleOsteoporotic FracturesProspective StudiesRadiographySpinal FracturesTreatment Outcome

Identifiers

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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.