Femoral Neck Fracture
Conditions
Keywords
Hemiarthroplasty, Cemented, Press Fit, Mortality, Morbidity, Functional Status, Displaced femoral neck fracture
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.
Interventions
DEVICECemented Hip Hemiarthroplasty
The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN.
DEVICEVerSys Beaded FullCoat, Zimmer
The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN,
Sponsors
Zimmer Biomet
Hartford Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 1 year | Assessment of post-operative mortality at one-year. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Energy/Fatigue Scale | 1 year | An inquire about fatigue, level of energy and self-efficiency. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cemented Hip Hemiarthroplasty This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN). | 66 |
| Press-Fit Hip Hemiarthroplasty This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN), | 64 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Total | Cemented Hip Hemiarthroplasty | Press-Fit Hip Hemiarthroplasty |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 130 Participants | 66 Participants | 64 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 82.3 years STANDARD_DEVIATION 8.3 | 81.8 years STANDARD_DEVIATION 9 | 82.8 years STANDARD_DEVIATION 7.6 |
| Region of Enrollment United States | 130 participants | 66 participants | 64 participants |
| Sex: Female, Male Female | 100 Participants | 52 Participants | 48 Participants |
| Sex: Female, Male Male | 30 Participants | 14 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 66 | 8 / 64 |
| serious Total, serious adverse events | 1 / 66 | 1 / 64 |
Outcome results
Primary
Mortality
Assessment of post-operative mortality at one-year.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cemented Hip Hemiarthroplasty | Mortality | 23.1 pecent |
| Press-Fit Hip Hemiarthroplasty | Mortality | 20.1 pecent |
Primary
Post-Operative Myocardial Infarction
Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.
Time frame: 1 week post-operation
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.
Time frame: 1 week post-operation
Secondary
Energy/Fatigue Scale
An inquire about fatigue, level of energy and self-efficiency.
Time frame: 1 year
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.
Time frame: 1 year