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

NCT ID: NCT02305121

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-11-30

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.

Conditions

Pertrochanteric Fractures of Femur; Intertrochanteric Fractures of the Femur

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Blauth, Professor

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck, Department of Trauma Surgery

Locations

Medical University Innsbruck

Innsbruck, , Austria

Kantonsspital Baselland

Liestal, , Switzerland

Countries

Austria; Switzerland

Other Identifiers

FR TFNA

Identifier Type: -

Identifier Source: org_study_id