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Performance Improvement Program on Imaging II

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ClinicalTrials.gov Identifier: NCT02272972
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

Brief Summary:

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.


Condition or disease Intervention/treatment
Hip Fractures Femoral Fractures Fractures, Bone Other: Application of knowledge

Detailed Description:

5 surgeons in 5 clinics will participate including a total of 125 prospective and 125 retrospective cases. This means 25+25 cases per clinic or 5+5 cases treated by each surgeon. The anonymized images of the surgeon's last 5 patients (retrospective part) and the pseudonymized images of the next 5 patients meeting the eligibility criteria (prospective part) will be assessed. 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).

Individually, the 5 surgeons per clinic review the 25 postimplant intraoperative lateral images filed for 5 retrospective cases using a set of predefined criteria.

After this first assessment of retrospective cases, the group watches a video and a poster and has one hour of time to discuss it. The group reviews the 25 cases from the pre-education step again within a period of maximum 5 days. The data are analyzed at AO Clinical Investigation and Documentation (AOCID) and provided to the surgeons for data review meeting where they agree on areas for improvement and set target goals for the prospective series. For the whole period of the second assessment and the prospective series, the poster is placed in the area of the operating room.

After patient information/consent, eligible patients are included into the prospective part of the study and treated with either an intramedullary nail or a DHS. During the surgery, the surgeons use the newly achieved knowledge to record images.

In the next step, the 5 surgeons per clinic review individually 25 postimplant intraoperative lateral images of 5 prospective cases using the same set of predefined criteria. The data are analyzed at AOCID and review by the Imaging Working Group of AO Education.

The data are not transferred between the clinics. The main outcomes will be assessed based on the "Questionnaire for the assessment of the lateral intraoperative view of the proximal femur".

This questionnaire consists of seven questions, on image quality (Q1 and Q2; part A) and on quality of reduction and surgery (Q3 - Q7; part B). Q1 and Q2 allow only "yes/no" answers, with an option to comment on the answer "no". Q3 to Q5 are based on anatomical assessments and Q6 and Q7 ask for evaluation of the surgery. There is a "not assessable" answer option for all questions of part B.

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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Other
Time Perspective: Other
Official Title: Performance Improvement Program on Imaging II
Study Start Date : October 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Retrospective group
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.
Prosp.group (Application of knowledge)
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.
Other: Application of knowledge
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.




Primary Outcome Measures :
  1. 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. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Interrater agreement between pre-educational and post-educational assessment of image quality (Q1-Q2) [ Time Frame: 6 months ]
  2. Proportion of images that are rated as "not assessable" (Q3-Q7) [ Time Frame: 6 months ]
  3. Proportion of "Quality of reduction and surgery" criteria with the best possible assessment (yes/optimal) (Q3-Q7) [ Time Frame: 6 months ]
  4. Interrater agreement between pre-educational and post-educational assessment of surgery's quality (Q3-Q7) [ Time Frame: 6 months ]
  5. Surgeons' experience (years and professional level) [ Time Frame: 6 months ]
  6. Surgeons practice (average number of hip surgeries per month) [ Time Frame: 6 months ]
  7. Self-assessment gap score [ Time Frame: 6 months ]
    (3 questions regarding the current and the desired level of ability in fixing pertrochanteric femoral fractures, obtaining lateral intraoperative images of the proximal femur and assessing lateral intraoperative images of the proximal femur)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

Inclusion Criteria:

  • Age 18 years and older
  • Diagnosis of a pertrochanteric femoral fracture (AO 31-A1, A2, A3)
  • Surgical treatment with either a Proximal Femoral Nail Antirotation (PFNA), a PFNA-II, a Dynamic Hip Screw (DHS) or a Titanium Trochanteric Fixation Nail System (TFN)

For the prospective part of the study:

Informed consent obtained, i.e.:

  • Ability to understand the content of the patient information/Informed Consent Form
  • Willingness to allow the use of health-related data (images) according to the Clinical Investigation Plan (CIP)
  • Signed and dated Ethics Committee (EC)/Institutional Review Board (IRB) approved written informed consent

Exclusion Criteria:

For the prospective part of the study: - Mentally handicapped patients or patients with dementia that are not able to understand the content patient information/Informed Consent Form


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272972


Locations
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United States, Missouri
University of Missouri Hospital and Clinics
Columbia, Missouri, United States, 65212
Austria
Hospital of the Medical University Graz
Graz, Austria, 8036
Slovenia
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Switzerland
Cantonal Hospital Winterthur
Winterthur, ZH, Switzerland, 8401
Municipal Hospital Triemli
Zurich, ZH, Switzerland, 8063
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
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Principal Investigator: Daniel Rikli, MD University Hospital, Basel, Switzerland

Publications:
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Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT02272972    
Other Study ID Numbers: PI program II
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Keywords provided by AO Clinical Investigation and Documentation:
"fluoroscopy"[MeSH], "education, medical"[MeSH]
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Hip Injuries
Leg Injuries