CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 130 enrolled
Drug / intervention
Cemented Hip Hemiarthroplasty +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01114646
NCT01114646N/ACompleted

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

Hartford Hospital·interventional·Posted May 3, 2010·Updated Aug 7, 2018

In Brief

A clinical study evaluating Cemented Hip Hemiarthroplasty and VerSys Beaded FullCoat, Zimmer for Femoral Neck Fracture. Completed, enrolled 130 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsZimmer Biomet

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 3, 2010
Enrollment StartMar 1, 2005
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 16.2 years ago

Interventions

Cemented Hip Hemiarthroplastydevice

The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN.

VerSys Beaded FullCoat, Zimmerdevice

The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN,