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Pertrochanteric Fractures of Femur
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Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™)

Sponsored by AO Clinical Investigation and Publishing Documentation

About this trial

Last updated 5 years ago

Study ID

FR TFNA

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status