Trochanter Fixation Nail Advanced (TFNA) Weight Bearing

A Prospective Study to Investigate Postoperative Real Life Weight Bearing Measured in Patients Treated With a Trochanter Fixation Nail Advanced (TFNA)

This study documents real life weight bearing in patients treated with a TFNA, who are allowed for immediate weight bearing as tolerated.

Study Overview

• Status: Terminated
• Conditions: Femur Fracture
• Intervention / Treatment: Procedure: Fracture fixation with the TFNA

Detailed Description

Prospective data will be collected from 30 patients presenting a per- or inter-trochanteric fracture of the femur treated with the TFNA. Post-operatively patients will be asked to wear a sensor insole in their shoes for up to 3 months after surgical treatment. The sensor insole will be used in both feet and will not have any impact in patient's activities of daily living while allowing real time measurements of weight bearing.

In addition to weight bearing measurements, perceived pain (numeric rating scale), mobility (Parker Mobility Score and Time Up and Go Test) will be assessed at 6 and 12 weeks after surgical treatment and in conjunction with the standard (routine) of care follow up schedule. In order to investigate the relationship between these variables and the weight bearing measurements, patients or their care takers or assisting family members will be asked to document the daily use of the insole in a diary.

Finally, over the course of the study, anticipated adverse events (AE) that may affect the healing process will be collected. Special attention will be given to implant- or bone-related AEs. Images from patients with implant- or bone related AEs will be collected as per standard of care

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medical University Innsbruck
• Switzerland
  • Binningen, Switzerland, 4101
    • Kantonsspital Baselland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient matching all of the inclusion and none of the exclusion criteria at the respective study sites are invited to join the study.

Description

Inclusion Criteria:

• Age 18 years and older

• Patients treated with the TFNA; i.e. according to the technique guide and the indications for use, patients who presented any of the following conditions:

  • Stable or unstable pertrochanteric fractures
  • Intertrochanteric fractures
  • Basal neck fractures
  • Combinations of pertrochanteric, intertrochanteric, and basal neck fractures
• Patients who were able to walk before the fracture and are prescribed full weight bearing as tolerated post-surgery
• Ability to understand the content of the patient information / informed consent form
• Willingness and ability to participate in the study according to the clinical investigation plan
• Signed and dated ethical committee approved written informed consent according to the local regulations

Exclusion Criteria:

• Patients who are not allowed to full weight bearing as tolerated post-surgery
• Any condition, which impairs weight bearing (e.g. additional acute fracture on the ipsilateral and/or contralateral side, pain)
• Patients, who due to their condition, are in opinion of the Prinicipal Investigator (PI) unable to complete a reliable assessment
• Pregnancy or women planning to conceive within the study period
• Participation in any other medical device or medicinal product registry within the previous month that could, in opinion of the PI, influence the results of the present study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight bearing	Time course of the weight bearing difference between the operated and the healthy legs within 3 months after surgery.	3 months

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Michael Blauth, Prof., Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures
• Other Study ID Numbers: TFNA weight bearing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No