Status:
COMPLETED
Performance Improvement Program on Imaging II
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Conditions:
Hip Fractures
Femoral Fractures
Eligibility:
All Genders
18+ years
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT02272972
Start Date
October 1 2014
End Date
May 1 2016
Last Update
August 13 2020
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Missouri Hospital and Clinics
Columbia, Missouri, United States, 65212
2
Hospital of the Medical University Graz
Graz, Austria, 8036
3
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
4
Cantonal Hospital Winterthur
Winterthur, Canton of Zurich, Switzerland, 8401