Status:
COMPLETED
Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™)
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Conditions:
Pertrochanteric Fractures of Femur
Intertrochanteric Fractures of the Femur
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this project is the prospective data collection of a new device used for trochanteric fractures of the femur. It should be answered how the newly developed implant called Trochanteric Fixat...
Detailed Description
In comparison to previous implants, the TFNA has been improved substantially. Therefore the purpose of this focused registry is to investigate how the newly developed implant called Trochanteric Fixat...
Eligibility Criteria
Inclusion
- Age 18 years and older
- Pertrochanteric femoral fracture (31-A1 and 31-A2), intertrochanteric fracture (31-A3), fracture of the trochanteric area (31-A1/A2/A3) with diaphyseal extension or combined fracture of the trochanteric area and the femoral shaft (32-A/B/C) treated with the TFNA system according to the technique guide
- Ability to understand the content of the patient information / informed consent form
- Willingness and ability to participate in the registry according to the registry plan (RP)
- Signed and dated IRB/EC-approved written informed consent or assent from a family member
Exclusion
- Additional acute fracture
- Any not medically managed severe systemic disease
- Recent history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment
- Pregnancy or women planning to conceive within the registry period
- Prisoner
- Participation in any other medical device or medicinal product registry within the previous month that could influence the results of the present registry
- Intraoperative decision to use implants other than the devices under investigation
Key Trial Info
Start Date :
March 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02305121
Start Date
March 1 2015
End Date
November 1 2017
Last Update
August 12 2020
Active Locations (2)
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1
Medical University Innsbruck
Innsbruck, Austria, 6020
2
Kantonsspital Baselland
Liestal, Switzerland, 4410