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

A Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™) - TFNA System in Patients With Proximal Inter-, Per- or Subtrochanteric Fractures

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.

Study Overview

• Status: Completed
• Conditions: Pertrochanteric Fractures of Femur; Intertrochanteric Fractures of the Femur
• Intervention / Treatment: Device: TFNA

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.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medical University Innsbruck
• Switzerland
  • Liestal, Switzerland, 4410
    • Kantonsspital Baselland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OR time	(in min)	Intraoperative
Fracture classification Classification	according to AO/OTA Fracture and Dislocation	Baseline
Parker Mobility Score	Evaluation of the mobility	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	up to 3 months

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Principal Investigator: Michael Blauth, Professor, Medical University Innsbruck, Department of Trauma Surgery

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: November 22, 2014
• First Submitted That Met QC Criteria: December 1, 2014
• First Posted (Estimate): December 2, 2014

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Nail; Trochanteric fracture; Fracture reduction; Antirotation; trochanteric area with diaphyseal extension; trochanteric area with femoral shaft
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Femoral Fractures; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: FR TFNA