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NCT01114646 · ClinicalTrials.gov registry record · NA
Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty
A NA study, sponsored by Hartford Hospital.
- Completed
- Registry status
- NA
- Development phase
- 130
- Enrollment target
NCT01114646 is a NA study that has completed, run by Hartford Hospital. The registered enrollment target is 130 participants.
The verdict
NCT01114646, a NA study, has completed, sponsored by Hartford Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 130 participants
- Enrollment target
Study 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
- DEVICE Cemented Hip Hemiarthroplasty
- DEVICE VerSys Beaded FullCoat, Zimmer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2005-03 |
| Est. Completion | 2009-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01114646
The ClinicalTrials.gov registry entry for NCT01114646 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hartford Hospital, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cemented Hip Hemiarthroplasty is the first listed.
NCT01114646 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01114646 about?
NCT01114646 is a clinical study titled "Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty". 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 fractur...
What is the current status of trial NCT01114646?
This trial is currently completed. It is a NA study. The enrollment target is 130 participants. The study started on 2005-03. Estimated completion is 2009-05.
What interventions are being tested in trial NCT01114646?
The interventions under investigation include: Cemented Hip Hemiarthroplasty (DEVICE), VerSys Beaded FullCoat, Zimmer (DEVICE).
Who is sponsoring clinical trial NCT01114646?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
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