Trochanter Fixation Nail Advanced (TFNA) Weight Bearing

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03160508
Study type	Observational
Source	AO Innovation Translation Center
Contact
Status	Terminated
Phase
Start date	October 20, 2017
Completion date	November 30, 2020

View Details

See also
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