Clinical Trial: Performance Improvement Program on Imaging II

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Performance Improvement Program on Imaging II

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 Summary:

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
Sponsor: AO Clinical Investigation and Documentation

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Interrater agreement between pre-educational and post-educational assessment of image quality (Q1-Q2) [ Time Frame: 6 months ]
  • Proportion of images that are rated as "not assessable" (Q3-Q7) [ Time Frame: 6 months ]
  • Proportion of "Quality of reduction and surgery" criteria with the best possible assessment (yes/optimal) (Q3-Q7) [ Time Frame: 6 months ]
  • Interrater agreement between pre-educational and post-educational assessment of surgery's quality (Q3-Q7) [ Time Frame: 6 months ]
  • Surgeons' experience (years and professional level) [ Time Frame: 6 months ]
  • Surgeons practice (average number of hip surgeries per month) [ Time Frame: 6 months ]
  • 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)


Original Secondary Outcome: Same as current

Information By: AO Clinical Investigation and Documentation

Dates:
Date Received: October 10, 2014
Date Started: October 2014
Date Completion: May 2016
Last Updated: March 16, 2016
Last Verified: March 2016