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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary:

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.


Sponsor: AO Clinical Investigation and Documentation

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: AO Clinical Investigation and Documentation

Dates:
Date Received: November 22, 2014
Date Started: March 2015
Date Completion: December 2017
Last Updated: January 30, 2017
Last Verified: January 2017