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 Fixation Nailing with anti-rotation feature (TFNA) is performing clinically and radiological in terms of intra- and postoperative complications.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
The rate of mechanical and surgical complications defined as the number of
Timeframe: up to 3 months
Trial details
NCT IDNCT02305121
SponsorAO Clinical Investigation and Publishing Documentation