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Completed

NCT Number: NCT02305121

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Innsbruck, Innsbruck, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. The rate of mechanical and surgical complications defined as the number of

    Time frame: 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 outcomes

  1. OR time

    Time frame: Intraoperative

    (in min)

  2. Fracture classification Classification

    Time frame: Baseline

    according to AO/OTA Fracture and Dislocation

  3. Parker Mobility Score

    Time frame: up to 3 months

    Evaluation of the mobility

  4. Quality of reduction and implant placement

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Official study title

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

Acronym: FR TFNA

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Dec 2, 2014
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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