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

NCT02305121 | Completed DMC

• 1 other identifier: FR TFNA
• Study Type: observational
• Target: 35
• Locations: 2 countries
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• OR time

  Intraoperative

• Fracture classification Classification

  Baseline

• Parker Mobility Score

  up to 3 months

• Quality of reduction and implant placement

  up to 3 months

Interventions

TFNA DEVICE

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead

Study Sites (2)

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

Kantonsspital Baselland

Liestal, 4410, Switzerland

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Michael Blauth, Professor

  Medical University Innsbruck, Department of Trauma Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2014
• First Posted: December 2, 2014
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2017
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

CH (1); AU (1)