Trial reportTrials2015
Surgeon, staff, and patient radiation exposure in minimally invasive transforaminal lumbar interbody fusion: impact of 3D fluoroscopy-based navigation partially replacing conventional fluoroscopy: study protocol for a randomized controlled trial.
Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
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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.
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.
Who cites it
9 citing papers in PubMed, 21 citations in OpenAlex.
- Medical Digital Twin: A Review on Technical Principles and Clinical Applications.Journal of clinical medicine · 2025Review
- Free-Hand MIS TLIF without 3D Navigation-How to Achieve Low Radiation Exposure for Both Surgeon and Patient.Journal of clinical medicine · 2023Article
- Is navigation beneficial for transforaminal endoscopic lumbar foraminotomy? A preliminary comparison study with fluoroscopic guidance.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 · 2023Article
- The Impact of Implementing a Radiation-Sparing Protocol for Percutaneous Kyphoplasty-A Prospective Dosemetric Study.Global spine journal · 2023Article
- Advanced Technologies for Outpatient Lumbar Fusion: Barriers and Opportunities.International journal of spine surgery · 2022Article
- The challenge of measuring spinopelvic parameters: inter-rater reliability before and after minimally invasive lumbar spondylodesis.BMC musculoskeletal disorders · 2022Article
- The Clinical Impact of Image Guidance and Robotics in Spinal Surgery: A Review of Safety, Accuracy, Efficiency, and Complication Reduction.International journal of spine surgery · 2021Review
- Narrative review of intraoperative image guidance for transforaminal lumbar interbody fusion.Annals of translational medicine · 2021Review
- Total 3D Airo® Navigation for Minimally Invasive Transforaminal Lumbar Interbody Fusion.BioMed research international · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSome symptomatic degenerative conditions of the lumbar spine may be treated with spinal fusion if conservative treatment has failed. The minimally invasive technique of transforaminal lumbar interbody fusion (MIS TLIF) is increasingly used but has been found to generate increased radiation exposure to the patient and staff. Modern three-dimensional (3D) C-arm devices are capable of providing conventional two-dimensional fluoroscopic images (x-rays) as well as 3D image sets for intraoperative navigation. This study was designed to compare the radiation exposure between these two intraoperative imaging techniques in MIS TLIF procedures.
methodsThis study is a randomized controlled trial. Forty participants scheduled to undergo monosegmental MIS TLIF will be recruited and randomly allocated to one of two groups with respect to the applied intraoperative imaging technique: conventional fluoroscopy (FLUORO group) and 3D fluoroscopy-based navigation combined with conventional fluoroscopy (NAV group). Furthermore, patients scheduled to undergo bisegmental MIS TLIF during the recruitment period for monosegmental MIS TLIF will be assessed for eligibility and will be randomly assigned separately. The primary endpoint is the radiation exposure to the surgeon and is measured by dosimeter readings. Secondary endpoints are the radiation exposure to the assistant surgeon, scrub nurse, anesthetist, patient, and C-arm as well as radiation exposure in relation to the body mass index of the patient. DISCUSSION: Results of this randomized study will help to compare the radiation exposure to the operating staff and patient during MIS TLIF procedures using conventional fluoroscopy versus 3D fluoroscopy-based navigation combined with conventional fluoroscopy. Furthermore, recommendations regarding the appropriate use of the investigated intraoperative imaging techniques will be made to improve radiation protection and to reduce radiation exposure.
trial registrationRegistration number of the German Clinical Trials Register: DRKS00004514 . Registration date: 11 August 2012.
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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.