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

Intertrochanteric Fractures of the Femur Clinical Trial

— FR TFNA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305121
• Other study ID #: FR TFNA
• Status: Completed
• Start date: March 2015
• Est. completion date: November 2017

Study information

• Verified date: August 2020
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Hip Fractures
• Intertrochanteric Fractures of the Femur
• Pertrochanteric Fractures of Femur

Intervention

Device:
• TFNA
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

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck
Switzerland	Kantonsspital Baselland	Liestal

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

Austria,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	OR time	(in min)	Intraoperative
Secondary	Fracture classification Classification	according to AO/OTA Fracture and Dislocation	Baseline
Secondary	Parker Mobility Score	Evaluation of the mobility	up to 3 months
Secondary	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