Clinical trial NCT02305121: Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™)
Official title: A Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™) - TFNA System in Patients With Proximal Inter-, Per- or Subtrochanteric Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pertrochanteric Fractures of Femur
Intertrochanteric Fractures of the Femur
Keywords: Trochanteric fracture
Nail
Fracture reduction
Antirotation
trochanteric area with diaphyseal extension
trochanteric area with femoral shaft
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with per- or intertrochanteric fractures of the femur, fracture of the trochanteric area with diaphyseal extension or combined fractures of the trochanteric area and the femoral shaft.

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 Fixation Nailing with anti-rotation feature (TFNA) is performing clinically and radiological in terms of intra- and postoperative complications.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of mechanical and surgical complications defined as the number of
timeFrame: up to 3 months
Secondary outcomes:
measure: OR time
timeFrame: Intraoperative
measure: Fracture classification Classification
timeFrame: Baseline
measure: Parker Mobility Score
timeFrame: up to 3 months
measure: Quality of reduction and implant placement
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
Study officials:
affiliation: Medical University Innsbruck, Department of Trauma Surgery
name: Michael Blauth, Professor
role: PRINCIPAL_INVESTIGATOR
References: