Performance Improvement Program on Imaging II

AO Clinical Investigation and Publishing Documentation

Status: Completed

Conditions: Hip Fractures; Femoral Fractures; Fractures, Bone

Treatments: Other: Application of knowledge

Study type: Observational

Funder types: Other

Identifiers

NCT02272972

PI program II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Retrospective group

Description:

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)

Description:

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.

Treatment:

Other: Application of knowledge