Trials / Terminated
TerminatedNCT03160508
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)
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 16 (actual)
- Sponsor
- AO Innovation Translation Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
This study documents real life weight bearing in patients treated with a TFNA, who are allowed for immediate weight bearing as tolerated.
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Fracture fixation with the TFNA | Fracture fixation with the TFNA |
Timeline
- Start date
- 2017-10-20
- Primary completion
- 2020-11-30
- Completion
- 2020-11-30
- First posted
- 2017-05-19
- Last updated
- 2021-07-07
Locations
2 sites across 2 countries: Austria, Switzerland
Source: ClinicalTrials.gov record NCT03160508. Inclusion in this directory is not an endorsement.