Hartford Hospital
Hartford, Connecticut, 06106, United States
NCT Number: NCT01114646
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.
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Notify Me55 year and older
All sexes
Interventional
Not applicable
Hartford, Connecticut, 06106, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN.
The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN,
Time frame: 1 year
Assessment of post-operative mortality at one-year.
Time frame: 1 week post-operation
Unstable angina was defined as the new onset of prolonged chest pain (greater than or equal to 30 minutes) or two episodes of chest pain thought to be of cardiac origin or an electrocardiogram showing new T-wave inversion, ST depression or elevation with enzymes non-diagnostic of myocardial ischemia.
Time frame: 1 week post-operation
Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.
Time frame: 1 year
A modified version of the Older Americans Resources and Services Instrument (OARS) which asks about performance of tasks of daily living during the preceding two weeks.14 These activities include: getting to places, walking distances, shopping for groceries or clothes, preparing meals and doing housecleaning.
Time frame: 1 year
An inquire about fatigue, level of energy and self-efficiency.
Hartford Hospital
Other
Functional Status, Morbidity and Mortality in Cemented Versus Uncemented Hemiarthroplasty for Subcapital Hip Fractures: A Prospective Randomized Trial
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