Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty
Primary Purpose
Femoral Neck Fracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cemented Hip Hemiarthroplasty
VerSys Beaded FullCoat, Zimmer
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fracture focused on measuring Hemiarthroplasty, Cemented, Press Fit, Mortality, Morbidity, Functional Status, Displaced femoral neck fracture
Eligibility Criteria
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
Sites / Locations
- Hartford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Cemented Hip Hemiarthroplasty
Press-Fit Hip Hemiarthroplasty
Arm Description
This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).
This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
Outcomes
Primary Outcome Measures
Mortality
Assessment of post-operative mortality at one-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.
Post-Operative Myocardial Infarction
Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.
Secondary Outcome Measures
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.
Energy/Fatigue Scale
An inquire about fatigue, level of energy and self-efficiency.
Full Information
NCT ID
NCT01114646
First Posted
April 29, 2010
Last Updated
July 31, 2018
Sponsor
Hartford Hospital
Collaborators
Zimmer Biomet
1. Study Identification
Unique Protocol Identification Number
NCT01114646
Brief Title
Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty
Official Title
Functional Status, Morbidity and Mortality in Cemented Versus Uncemented Hemiarthroplasty for Subcapital Hip Fractures: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital
Collaborators
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fracture
Keywords
Hemiarthroplasty, Cemented, Press Fit, Mortality, Morbidity, Functional Status, Displaced femoral neck fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cemented Hip Hemiarthroplasty
Arm Type
Other
Arm Description
This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).
Arm Title
Press-Fit Hip Hemiarthroplasty
Arm Type
Experimental
Arm Description
This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
Intervention Type
Device
Intervention Name(s)
Cemented Hip Hemiarthroplasty
Intervention Description
The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN.
Intervention Type
Device
Intervention Name(s)
VerSys Beaded FullCoat, Zimmer
Intervention Description
The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN,
Primary Outcome Measure Information:
Title
Mortality
Description
Assessment of post-operative mortality at one-year.
Time Frame
1 year
Title
Post-Operative Unstable Angina
Description
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
Title
Post-Operative Myocardial Infarction
Description
Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.
Time Frame
1 week post-operation
Secondary Outcome Measure Information:
Title
Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) Scale
Description
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
Title
Energy/Fatigue Scale
Description
An inquire about fatigue, level of energy and self-efficiency.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph P. DeAngelis, MD
Organizational Affiliation
Hartford Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Courtland G. Lewis, MD
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty
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