Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™)

AO Clinical Investigation and Publishing Documentation35 enrolled

Overview

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.

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 Fixation Nailing with anti-rotation feature (TFNA) is performing clinically and radiologically in terms of surgical technique, intra- and postoperative complications and short term outcome. All investigated procedures are part of the standard of care treatment. Only the parker mobility score is study-specific. All patients included are followed up from the time point of enrollment until three months after surgery.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pertrochanteric Fractures of Femur Intertrochanteric Fractures of the Femur

Interventions

TFNADEVICE

All investigated procedures are part of the standard of care treatment. Only the parker mobility score is study-specific. All patients included are followed up from the time point of enrollment until three months after surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Medical University Innsbruck

Innsbruck, Austria

Kantonsspital Baselland

Liestal, Switzerland

Outcomes

Primary Outcomes

The rate of mechanical and surgical complications defined as the number of

* cut out and cut through * secondary displacement of parts of the implant * breakage of the implant * iatrogenic fractures * surgical revisions * acute deep infection

Time frame: up to 3 months

Secondary Outcomes

OR time

(in min)

Time frame: Intraoperative

Fracture classification Classification

according to AO/OTA Fracture and Dislocation

Time frame: Baseline

Parker Mobility Score

Evaluation of the mobility

Time frame: up to 3 months

Quality of reduction and implant placement

Based on radiographic analysis with focus on the position of the nail tip relative to the femoral canal and the migration of the head neck element

Time frame: up to 3 months

Data from ClinicalTrials.gov

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