Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty
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|ClinicalTrials.gov Identifier: NCT01114646|
Recruitment Status : Completed
First Posted : May 3, 2010
Last Update Posted : February 10, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Femoral Neck Fracture||Device: Cemented Hip Hemiarthroplasty Device: VerSys Beaded FullCoat, Zimmer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Functional Status, Morbidity and Mortality in Cemented Versus Uncemented Hemiarthroplasty for Subcapital Hip Fractures: A Prospective Randomized Trial|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Cemented Hip Hemiarthroplasty
This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).
Device: Cemented Hip Hemiarthroplasty
The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN.
Experimental: Press-Fit Hip Hemiarthroplasty
This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
Device: VerSys Beaded FullCoat, Zimmer
The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN,
- Mortality [ Time Frame: 1 year ]Assessment of post-operative mortality at one-year.
- Post-Operative Unstable Angina [ 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.
- Post-Operative Myocardial Infarction [ Time Frame: 1 week post-operation ]Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.
- Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) scale [ 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.
- Energy/Fatigue Scale [ Time Frame: 1 year ]An inquire about fatigue, level of energy and self-efficiency.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114646
|United States, Connecticut|
|Hartford, Connecticut, United States, 06106|
|Study Director:||Joseph P. DeAngelis, MD||Hartford Hospital|
|Principal Investigator:||Courtland G. Lewis, MD||Hartford Hospital|