Evidence map›Paper›PMID 26844224›Full record

Trial reportBioMed research international2015

Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study.

David Noriega, Gianluca Maestretti, Christian Renaud, Natale Francaviglia, Mourad Ould-Slimane, Steffen Queinnec, Helmut Ekkerlein, Frank Hassel, Rainer Gumpert, Pascal Sabatier and 5 more

Open access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in BioMed research international, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 17% 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.

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

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 67 citations in OpenAlex.

  1. Pooled it
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  16. Treatment of thoracolumbar burst fractures: SpineJackJournal of spine surgery (Hong Kong) · 2022
    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

15 authors at 11 institutions in 5 countries.

David NoriegaValladolid University Hospital, Royal Academy of Medicine and Surgery, 47008 Valladolid, Spain.
Gianluca MaestrettiDepartment of Orthopedic Surgery, Spine Unit, HFR Fribourg-Cantonal Hospital, 1708 Fribourg, Switzerland.
Christian RenaudDepartment of Orthopedics, Toulouse Lautrec Clinic, 81030 Albi, France.
Natale FrancavigliaDepartment of Neurosurgery, A.R.N.A.S. Civico Di Cristina Benfratelli, 90127 Palermo, Italy.
Mourad Ould-SlimaneDepartment of Orthopedic Surgery, University Hospital of Rouen, 76031 Rouen, France.
Steffen QueinnecDepartment of Orthopedic Surgery, Hospital Beaujon, 92110 Clichy, France.
Helmut EkkerleinDepartment of Trauma and Orthopedic Surgery, Südostbayern AG Clinic, Traunstein Clinic, 83278 Traunstein, Germany.
Frank HasselDepartment of Spine Surgery, Loretto Hospital, 79100 Freiburg, Germany.
Rainer GumpertLKH-Univ. Klinikum Graz, 8036 Graz, Austria.
Pascal SabatierDepartment of Neurosurgery, Clinic of Cèdres, 31700 Cornebarrieu, France.
Hervé HuetDepartment of Neuroradiology, Regional University Hospital, 14033 Caen, France.
Miguel PlasenciaDepartment of Traumatology and Orthopedic Surgery, University Hospital Principe De Asturias, 28805 Madrid, Spain.
Nicolas TheumannDepartment of Radiology, Bois-Cerf Clinic, 1006 Lausanne, Switzerland.
Alexander KunskyDepartment of Neurosurgery Spine, Private Hospital Sévigné, 35567 Cesson-Sévigné, France.
Antonio KrügerDepartment of Trauma and Reconstructive Surgery, Philipps University of Marburg, University Hospital of Giessen and Marburg, 35043 Marburg, Germany.
Clinique des Cèdres · FRFribourg Development Agency · CHGraz University Hospital · ATHirslanden Clinique Bois-Cerf · CHHôpital Beaujon · FRHospital Universitario Príncipe de Asturias · ESKreisklinik Trostberg · DEUniversidad de Valladolid · ESUniversitätsklinikum Gießen und Marburg · DEUniversité de Caen Normandie · FRUniversité de Rouen Normandie · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (-5.4 ± 6.3°; p < 0.001), remained at 12 months (-4.4 ± 6.0°, p = 0.002). No adverse events were implant-related and none required device removal. Three patients (2.9%) experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.

Indexed as

Quality of LifeAgedAged, 80 and overBack PainFemaleHumansMaleMiddle AgedOsteoporosisProspective StudiesSpinal Fractures

Identifiers

PMID26844224
PMCPMC4710926
OpenAlexW2196933747

What OpenQuestion holds

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LicenceCC BY
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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.