Trochanter Fixation Nail Advanced (TFNA) Weight Bearing

NCT03160508 | Terminated

• 1 other identifier: TFNA weight bearing
• Study Type: observational
• Target: 16
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Femur Fracture

Outcome Measures

Primary Outcomes (1)

• Weight bearing

  Time course of the weight bearing difference between the operated and the healthy legs within 3 months after surgery.

  3 months

Interventions

Fracture fixation with the TFNA PROCEDURE

Fracture fixation with the TFNA

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (2)

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

Kantonsspital Baselland

Binningen, 4101, Switzerland

Location

MeSH Terms

Conditions

Femoral Fractures

Interventions

Fracture Fixation

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Michael Blauth, Prof.

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 19, 2017
• Study Start: October 20, 2017
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: July 7, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); AU (1)