Clinical trial NCT01114646: 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
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Fracture
Keywords: Hemiarthroplasty
Cemented
Press Fit
Mortality
Morbidity
Functional Status
Displaced femoral neck fracture
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2010-05-03
Enrollment: 130
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mortality
timeFrame: 1 year
measure: Post-Operative Unstable Angina
timeFrame: 1 week post-operation
measure: Post-Operative Myocardial Infarction
timeFrame: 1 week post-operation
Secondary outcomes:
measure: Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) Scale
timeFrame: 1 year
measure: Energy/Fatigue Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Joseph P. DeAngelis, MD
role: STUDY_DIRECTOR
affiliation: Hartford Hospital
name: Courtland G. Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References: