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

Not Applicable

Completed

Interventions: Device: Cemented Hip Hemiarthroplasty
Device: VerSys Beaded FullCoat, Zimmer

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Cemented Hip Hemiarthroplasty	Cemented Hip Hemiarthroplasty	This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).
Press-Fit Hip Hemiarthroplasty	VerSys Beaded FullCoat, Zimmer	This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),

Primary Outcome Measures

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

Secondary Outcome Measures

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