NCT02272972|Completed
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Sponsor study identifier
observational
250
4 countries
5
Study Start
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Actual (reported)Study Completion
May 2016
Actual (reported)This study consists of a retrospective and a prospective part. For each part and in each of 5 clinics, one intraoperative postimplant image (lateral view) of 25 patients with pertrochanteric fractures will be assessed by 5 surgeons per clinic. There are two assessments in the retrospective part. a) before an educational intervention, b) after the educational intervention. The evaluated images at these two timepoints are identical. In the prospective part, the surgeons apply their new knowledge from the educational intervention. They perform the positioning of the patient during the intraoperative fluoroscopy and record the image according to the teaching material. One postimplant image of each patient will be used for the evaluation. At all three timepoints of image assessment, a questionnaire with the same set of 7 criteria (Q1-Q7) for assessing the radiographs is used. The criteria refer to the content of the educational material.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 10, 2014
Actual (reported)October 23, 2014
Actual (reported)April 2016
Actual (reported)May 2016
Actual (reported)Image quality as determined by The proportion of "yes" answers to Q1 and Q2 in the post-educational assessment II compared to the proportion of "yes" answers to Q1 and Q2 pre-educational assessment.
6 months
Interrater agreement between pre-educational and post-educational assessment of image quality (Q1-Q2)
6 months
Proportion of images that are rated as "not assessable" (Q3-Q7)
6 months
Proportion of "Quality of reduction and surgery" criteria with the best possible assessment (yes/optimal) (Q3-Q7)
6 months
Interrater agreement between pre-educational and post-educational assessment of surgery's quality (Q3-Q7)
6 months
Surgeons' experience (years and professional level)
6 months
One x-ray image per patient is assessed by the surgeon. The surgeon undergoes an educational intervention (video/poster) and applies the achieved knowledge during the second assessment of the same image. The intervention is not administered to patients, only to an image.
No direct intervention at the patient. The surgeon applies the achieved knowledge during the performance of the fluoroscopy in the operating room. This image is assessed.
Educational Intervention has been performed at the treating surgeon (video and poster). The surgeons applies the achieved knowledge when performing the intraoperative fluoroscopy in patients with pertrochanteric fractures.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients are eligible if they are at least 18 years old, have an AO 31-A1, A2 or A3 fracture and were treated with either a Proximal Femoral nail Antirotation (PFNA), a PFNA- II, a Dynamic Hip Screw (DHS) or a Titanium Trochanteric Fixation Nail System (TFN).
University of Missouri Hospital and Clinics
Columbia, Missouri, 65212, United States
Hospital of the Medical University Graz
Graz, 8036, Austria
University Medical Centre Ljubljana
Ljubljana, 1000, Slovenia
Cantonal Hospital Winterthur
Winterthur, Canton of Zurich, 8401, Switzerland
Municipal Hospital Triemli
Zurich, Canton of Zurich, 8063, Switzerland
Heetveld MJ, Raaymakers EL, van Walsum AD, Barei DP, Steller EP. Observer assessment of femoral neck radiographs after reduction and dynamic hip screw fixation. Arch Orthop Trauma Surg. 2005 Apr;125(3):160-5. doi: 10.1007/s00402-004-0780-4. Epub 2005 Mar 2.
Karanicolas PJ, Bhandari M, Walter SD, Heels-Ansdell D, Sanders D, Schemitsch E, Guyatt GH. Interobserver reliability of classification systems to rate the quality of femoral neck fracture reduction. J Orthop Trauma. 2009 Jul;23(6):408-12. doi: 10.1097/BOT.0b013e31815ea017.
Daniel Rikli, MD
University Hospital, Basel, Switzerland
250 participants (actual enrollment reported by the registry).
First Submitted
October 10, 2014
First Posted
October 23, 2014
Study Start
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
Locked Versus Unlocked Set Screws in Intramedullary Fixation of Intertrochanteric Fractures
Contact the study team to confirm eligibility.
Rushton MN, Rushton VE, Worthington HV. The value of a quality improvement programme for panoramic radiography: a cluster randomised controlled trial. J Dent. 2013 Apr;41(4):328-35. doi: 10.1016/j.jdent.2012.12.009. Epub 2013 Jan 18.
Zisblatt L, Kues JR, Davis N, Willis CE. The long-term impact of a performance improvement continuing medical education intervention on osteoporosis screening. J Contin Educ Health Prof. 2013 Fall;33(4):206-14. doi: 10.1002/chp.21200.
Cannon CP, Hoekstra JW, Larson DM, Karcher RB, Mencia WA, Berry CA, Stowell SA. A report of quality improvement in the care of patients with acute coronary syndromes. Crit Pathw Cardiol. 2011 Mar;10(1):29-34. doi: 10.1097/HPC.0b013e318204eb8b.
Krettek C, Miclau T, Grun O, Schandelmaier P, Tscherne H. Intraoperative control of axes, rotation and length in femoral and tibial fractures. Technical note. Injury. 1998;29 Suppl 3:C29-39. doi: 10.1016/s0020-1383(98)95006-9.
Primary Completion
April 2016
Actual (reported)Study Completion
May 2016
Actual (reported)Last Updated
August 13, 2020
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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