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

Completed

• Conditions: Pertrochanteric Fractures of Femur; Intertrochanteric Fractures of the Femur

• Registration Number: NCT02305121
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

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.

Study Timeline

• Study First Submitted: 2014-11-22
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-02
• Study Start: 2015-03
• Primary Completion: 2016-06
• Study Completion: 2017-11
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of mechanical and surgical complications defined as the number of	up to 3 months	* cut out and cut through; * secondary displacement of parts of the implant; * breakage of the implant; * iatrogenic fractures; * surgical revisions; * acute deep infection

Secondary Outcome Measures

Name	Time	Method
OR time	Intraoperative	(in min)
Fracture classification Classification	Baseline	according to AO/OTA Fracture and Dislocation
Parker Mobility Score	up to 3 months	Evaluation of the mobility
Quality of reduction and implant placement	up to 3 months	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

Trial Locations

Locations (2)

Medical University Innsbruck; 🇦🇹 Innsbruck, Austria

Kantonsspital Baselland; 🇨🇭 Liestal, Switzerland