A Phase 4 interventional study of Proximal Femoral Nail AntirotationTM (PFNA) and Gamma Nail 3TM (Gamma3) in Unstable Trochanteric Fractures, sponsored by AO Clinical Investigation and Publishing Documentation. Completed at 6 sites in Spain. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-11.
Sponsored by AO Clinical Investigation and Publishing Documentation · Phase 4, Interventional, and Treatment
The purpose of this study is to compare rates of any fracture fixation complication and revision rates after intramedullary fixation of unstable trochanteric fractures between the Proximal Femoral Nail Antirotation™ (PFNA)(Investigational Group) and Gamma Nail 3™ (Gamma3) (Control Group).
Intramedullary nailing of unstable per- and subtrochanteric femoral fractures is a standard procedure in trauma and orthopaedic surgery. Unstable fractures treated with intramedullary nailing carry the risk of fracture fixation complications. The PFNA (Synthes) has evolved from the original PFN design, featuring a novel antirotation screw. Apart from the prevention of excess rotational forces, this supporting element may enhance the overall stability of the construct, thus potentially reducing fracture fixation complications. Empirical information about the fracture fixation complication rates of the PFNA device is not available. The primary objective of this study is to compare the 1-year fracture fixation rates between the PFNA and Gamma Nail 3™ (Stryker). Secondary objectives of the study are to compare differences in functional outcomes, quality of life outcomes, safety, radiological outcomes, handling and perceived effectiveness between the devices.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 440 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →AO Clinical Investigation and Publishing Documentation is the lead sponsor of 49 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Proximal Femoral Nail AntirotationTM (PFNA)
Device: Proximal Femoral Nail AntirotationTM (PFNA)
Gamma Nail 3TM (Gamma3)
Device: Gamma Nail 3TM (Gamma3)
intramedullary nailing
intramedullary nailing
Any fracture fixation complication.
Time frame: One year
Bone union/fusion as evaluated by CT-scanning, health-related quality of life, disease-specific functional scoring, activities of daily living, mortality, radiological parameters, surgery details and surgeons' evaluation of handling and effectiveness.
Time frame: One year
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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AO Clinical Investigation and Publishing Documentation