Clinical trial NCT02272972: Performance Improvement Program on Imaging II
Official title: Performance Improvement Program on Imaging II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Femoral Fractures
Fractures, Bone
Keywords: "fluoroscopy"[MeSH], "education, medical"[MeSH]
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2014-10-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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).

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Interrater agreement between pre-educational and post-educational assessment of image quality (Q1-Q2)
timeFrame: 6 months
measure: Proportion of images that are rated as "not assessable" (Q3-Q7)
timeFrame: 6 months
measure: Proportion of "Quality of reduction and surgery" criteria with the best possible assessment (yes/optimal) (Q3-Q7)
timeFrame: 6 months
measure: Interrater agreement between pre-educational and post-educational assessment of surgery's quality (Q3-Q7)
timeFrame: 6 months
measure: Surgeons' experience (years and professional level)
timeFrame: 6 months
measure: Surgeons practice (average number of hip surgeries per month)
timeFrame: 6 months
measure: Self-assessment gap score
timeFrame: 6 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Hospital and Clinics
state: Missouri
city: Graz
country: Austria
facility: Hospital of the Medical University Graz
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Winterthur
country: Switzerland
facility: Cantonal Hospital Winterthur
state: ZH
city: Zurich
country: Switzerland
facility: Municipal Hospital Triemli
state: ZH
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Daniel Rikli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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