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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02305121
• Date of registration: 22/11/2014
• Prospective Registration: Yes
• Primary sponsor: AO Clinical Investigation and Publishing Documentation
• Public title: Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™) FR TFNA
• Scientific title: A Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™) - TFNA System in Patients With Proximal Inter-, Per- or Subtrochanteric Fractures
• Date of first enrolment: March 2015
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02305121
• Study type: Observational

Countries of recruitment

Austria, Switzerland

Contacts

• Name: Michael Blauth, Professor
• Affiliation: Medical University Innsbruck, Department of Trauma Surgery

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pertrochanteric Fractures of Femur

Intertrochanteric Fractures of the Femur

Intervention(s)

Device: TFNA

Primary Outcome(s)

The rate of mechanical and surgical complications defined as the number of [Time Frame: up to 3 months]

Secondary Outcome(s)

OR time [Time Frame: Intraoperative]

Quality of reduction and implant placement [Time Frame: up to 3 months]

Fracture classification Classification [Time Frame: Baseline]

Parker Mobility Score [Time Frame: up to 3 months]

Secondary ID(s)

FR TFNA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors