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| ID | Type | Description | Link |
|---|---|---|---|
| 124013 | Other Identifier | Hartford Hospital IRB |
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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cemented Hip Hemiarthroplasty | Other | This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN). |
|
| Press-Fit Hip Hemiarthroplasty | Experimental | This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN), |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cemented Hip Hemiarthroplasty | Device | The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph P. DeAngelis, MD | Hartford Hospital | Study Director |
| Courtland G. Lewis, MD | Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cemented Hip Hemiarthroplasty | This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN). |
| FG001 | Press-Fit Hip Hemiarthroplasty | This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN), |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cemented Hip Hemiarthroplasty | This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN). |
| BG001 | Press-Fit Hip Hemiarthroplasty |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality | Assessment of post-operative mortality at one-year. | Posted | Number | pecent | 1 year |
|
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Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days.
other events such pneumonia, wound infection, thromboembolic event, cerebrovascular accident major hemorrhage will be assessed by concurrent medical record review. Hospital outcome will be assessed by surgical and medical team. Functional outcome will be completed over the telephone (self-reported)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cemented Hip Hemiarthroplasty | This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ICU stay | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arben Ademi, CCRP | Hartford Hostpial | 860-972-3561 | arben.ademi@hhcealth.org |
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| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| VerSys Beaded FullCoat, Zimmer | Device | The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN, |
|
| 1 year |
| Energy/Fatigue Scale | An inquire about fatigue, level of energy and self-efficiency. | 1 year |
This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | 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. | Not Posted | 1 week post-operation | Participants |
| Primary | Post-Operative Myocardial Infarction | Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction. | Not Posted | 1 week post-operation | Participants |
| Secondary | 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. | Not Posted | 1 year | Participants |
| Secondary | Energy/Fatigue Scale | An inquire about fatigue, level of energy and self-efficiency. | Not Posted | 1 year | Participants |
| 1 |
| 66 |
| 11 |
| 66 |
| EG001 | Press-Fit Hip Hemiarthroplasty | This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN), | 1 | 64 | 8 | 64 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Wound Infection | Infections and infestations | Systematic Assessment |
|
| Re-operation | Surgical and medical procedures | Systematic Assessment |
|
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| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |