Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty

Femoral Neck Fracture Clinical Trial

Official title:

Functional Status, Morbidity and Mortality in Cemented Versus Uncemented Hemiarthroplasty for Subcapital Hip Fractures: A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114646
• Other study ID #: 03001334HU
• Secondary ID: 124013
• Status: Completed
• Phase: N/A
• Start date: March 2005
• Est. completion date: May 2009

Study information

• Verified date: March 2013
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone

Intervention

Device:
• Cemented Hip Hemiarthroplasty
The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN.
• VerSys Beaded FullCoat, Zimmer
The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN,

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Hartford Hospital	Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Assessment of post-operative mortality at one-year.	1 year
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.	1 week post-operation
Primary	Post-Operative Myocardial Infarction	Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.	1 week post-operation
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.	1 year
Secondary	Energy/Fatigue Scale	An inquire about fatigue, level of energy and self-efficiency.	1 year