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

Study Overview
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Brief Summary
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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.

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

Conditions
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Femoral Neck Fracture

Intervention / Treatment
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* Device: Cemented Hip Hemiarthroplasty
* Device: VerSys Beaded FullCoat, Zimmer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: older than 55 years non-pathologic, displaced subcapital femoral neck fracture designated for surgical reconstruction with a hemiarthroplasty by the attending surgeon able to ambulate ten feet prior to presentation Exclusion Criteria: unable to walk ten feet prior to hip fracture multiple extremity trauma pathologic fracture of the hip (including malignancy) clinically recognized acute myocardial infarction within thirty days prior to enrollment previously participated in the trial symptoms associated with anemia pre-existing metabolic bone disease

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cemented Hip Hemiarthroplasty<br>This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN). | Device: Cemented Hip Hemiarthroplasty<br>* The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN.<br>|
| Experimental: Press-Fit Hip Hemiarthroplasty<br>This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN), | Device: VerSys Beaded FullCoat, Zimmer<br>* The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Assessment of post-operative mortality at one-year. | 1 year | 
| Post-Operative Unstable Angina | 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. | 1 week post-operation | 
| Post-Operative Myocardial Infarction | Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction. | 1 week post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) Scale | 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. | 1 year | 
| Energy/Fatigue Scale | An inquire about fatigue, level of energy and self-efficiency. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemiarthroplasty, Cemented, Press Fit, Mortality, Morbidity, Functional Status, Displaced femoral neck fracture