An interventional study of Cemented Hip Hemiarthroplasty and VerSys Beaded FullCoat, Zimmer in Femoral Neck Fracture, sponsored by Hartford Hospital. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by Hartford Hospital · Not applicable, Interventional, and Treatment
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 130 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Hartford Hospital is the lead sponsor of 101 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).
Device: Cemented Hip Hemiarthroplasty
This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
Device: VerSys Beaded FullCoat, Zimmer
The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN.
The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN,
Mortality
Assessment of post-operative mortality at one-year.
Time frame: 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.
Time frame: 1 week post-operation
Post-Operative Myocardial Infarction
Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.
Time frame: 1 week post-operation
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
Energy/Fatigue Scale
An inquire about fatigue, level of energy and self-efficiency.
Time frame: 1 year
| Milestone | Cemented Hip Hemiarthroplasty | Press-Fit Hip Hemiarthroplasty |
|---|---|---|
| Started | 66 | 64 |
| Completed | 63 | 62 |
| Not completed | 3 | 2 |
| Withdrew: Withdrawal by subject | 3 | 2 |
Assessment of post-operative mortality at one-year.
| pecent | Cemented Hip Hemiarthroplasty | Press-Fit Hip Hemiarthroplasty |
|---|---|---|
| Mortality | 23.1 | 20.1 |
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.
Results for this outcome have not been posted.
Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
An inquire about fatigue, level of energy and self-efficiency.
Results for this outcome have not been posted.
Collected over Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cemented Hip Hemiarthroplasty | — | 1/66 (1.5%) | 11/66 (16.7%) |
| Press-Fit Hip Hemiarthroplasty | — | 1/64 (1.6%) | 8/64 (12.5%) |
| Event | Cemented Hip Hemiarthroplasty | Press-Fit Hip Hemiarthroplasty |
|---|---|---|
| DeathCardiac disorders | 1/66 | 1/64 |
| Event | Cemented Hip Hemiarthroplasty | Press-Fit Hip Hemiarthroplasty |
|---|---|---|
| ICU stayGeneral disorders | 4/66 | 5/64 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 3/66 | 1/64 |
| Myocardial InfarctionCardiac disorders | 2/66 | 1/64 |
| Wound InfectionInfections and infestations | 1/66 | 1/64 |
| Re-operationSurgical and medical procedures | 1/66 | 0/64 |
| Age, Categorical(Participants) | Cemented Hip Hemiarthroplasty | Press-Fit Hip Hemiarthroplasty | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 66 | 64 | 130 |
| Age, Continuous(years) | Cemented Hip Hemiarthroplasty | Press-Fit Hip Hemiarthroplasty | Total |
|---|---|---|---|
| Mean | 81.8 ± 9.0 | 82.8 ± 7.6 | 82.3 ± 8.3 |
| Sex: Female, Male(Participants) | Cemented Hip Hemiarthroplasty | Press-Fit Hip Hemiarthroplasty | Total |
|---|---|---|---|
| Female | 52 | 48 | 100 |
| Male | 14 | 16 | 30 |
| Region of Enrollment(participants) | Cemented Hip Hemiarthroplasty | Press-Fit Hip Hemiarthroplasty | Total |
|---|---|---|---|
| United States | 66 | 64 | 130 |
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