Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty
Completed · Not applicable
Conditions studied: Femoral Neck Fracture
In brief
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.
Key facts
- Study ID
- NCT01114646
- Run by
- Hartford Hospital
- People needed
- 130
- Starts
- 2005-03-01
- Expected to finish
- 2009-05-01
- Last updated by the study team
- 2018-08-07
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hartford Hospital — Hartford, Connecticut, United States
Full record on ClinicalTrials.gov
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