NCT01114646

Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty

Functional Status, Morbidity and Mortality in Cemented Versus Uncemented Hemiarthroplasty for Subcapital Hip Fractures: A Prospective Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

Hemiarthroplasty (half of a hip replacement) is the most common treatment for displaced fractures of the femoral neck in the elderly and is associated with a better functional outcome and fewer reoperations than internal fixation. Currently, the operative management of displaced femoral neck fractures favors the use of cemented implants. This technique is believed to be more stable in the immediate post-operative period, but there is limited evidence of a decreased morbidity and mortality with cemented versus press-fit stems (uncemented). In 2006, a meta-analysis concluded that the evidence was too limited to recommend a cemented or press-fit hemiarthroplasty. In this investigation, the morbidity, mortality and functional outcome associated with cemented and press-fit hemiarthroplasty will be compared prospectively. We propose that the use of press-fit hemiarthroplasty in the treatment of displaced subcapital fractures of the femoral neck would be associated with a decreased risk of adverse peri-operative outcomes, and that the functional results of cemented and press-fit hemiarthroplasty will be equivalent at one year.

Conditions

• Femoral Neck Fracture

Interventions

Type	Name	Description
DEVICE	Cemented Hip Hemiarthroplasty	The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN.
DEVICE	VerSys Beaded FullCoat, Zimmer	The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN,

Timeline

• Start date: 2005-03-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2010-05-03
• Last updated: 2018-08-07
• Results posted: 2018-08-07

Locations

1 site across 1 country: United States