NCT01473082

Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

Comparison of Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation for the Treatment of Closed Unstable Trochanteric Fractures - A Randomized-controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: AO Clinical Investigation and Publishing Documentation · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether patients with trochanteric fractures being treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be mobilized than patients without augmentation.

Detailed description

To avoid the pain-causing relative movement between implant and bone, surgical techniques and devices allowing augmentation of the femoral head have recently been developed. Biomechanical studies showed that augmentation leads to a better axial stability and pull-out strength. In clinical practice, this might facilitate early mobilization and full weight-bearing with less pain. The purpose of this study is therefore to evaluate whether patients with trochanteric fractures being treated with a PFNA and augmentation can better be mobilized than patients without augmentation. In particular, it will be measured whether patients with a PFNA Augmentation can walk faster than the non-augmented patients, measured with the Timed up and Go test.

Conditions

• Hip Fractures
• Closed Fracture of Hip

Interventions

Type	Name	Description
DEVICE	PFNA Augmentation (Synthes)	Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+)
DEVICE	PFNA (Synthes)	Proximal Femoral Nail Antirotation (PFNA)

Timeline

• Start date: 2012-02-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2011-11-17
• Last updated: 2020-08-13

Locations

9 sites across 6 countries: Austria, Belgium, Germany, Israel, Norway, Switzerland