NCT00873548

Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation (PFNA)-Asia

Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation Asia - A Prospective Multicenter Case Series

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 245 (actual)
• Sponsor: AO Clinical Investigation and Publishing Documentation · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this prospective multicenter study is to assess any fracture fixation complication and revision rates during the clinical use of the Proximal Femoral Nail Antirotation Asia (PFNA Asia) for the treatment of unstable trochanteric fractures.

Detailed description

From several studies, e.g. on hip prostheses, it is known that the Asian population has other geometric proportions than Caucasians, e.g. Japanese woman have shorter femoral necks, smaller femoral neck angles and a more anterior bowing of the shaft than white Americans. This was one of the reasons for the development of a new PFNA Asia with adapted sizes and geometry. No controlled clinical data are available whether the rate of mismatch and mismatch-related complications could be reduced.

Conditions

• Trochanteric Fractures

Interventions

Type	Name	Description
DEVICE	PFNA-Asia	The operation is performed under regional or general anesthesia and involves the following main steps: 1. Positioning of the patient 2. Definition of the CCD-angle 3. Fracture reduction 4. Determination of the nail diameter 5. Incision 6. Insertion of the device

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-12-01
• Completion: 2012-03-01
• First posted: 2009-04-01
• Last updated: 2021-07-22

Locations

1 site across 1 country: Japan