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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01114646
First Posted: May 3, 2010
Last Update Posted: February 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Hartford Hospital
  Purpose

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.


Condition Intervention
Femoral Neck Fracture Device: Cemented Hip Hemiarthroplasty Device: VerSys Beaded FullCoat, Zimmer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Status, Morbidity and Mortality in Cemented Versus Uncemented Hemiarthroplasty for Subcapital Hip Fractures: A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Mortality [ Time Frame: 1 year ]
    Assessment of post-operative mortality at one-year.

  • Post-Operative Unstable Angina [ Time Frame: 1 week post-operation ]
    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.

  • Post-Operative Myocardial Infarction [ Time Frame: 1 week post-operation ]
    Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.


Secondary Outcome Measures:
  • Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) scale [ Time Frame: 1 year ]
    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.

  • Energy/Fatigue Scale [ Time Frame: 1 year ]
    An inquire about fatigue, level of energy and self-efficiency.


Enrollment: 130
Study Start Date: March 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cemented Hip Hemiarthroplasty
This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).
Device: Cemented Hip Hemiarthroplasty
The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN.
Experimental: Press-Fit Hip Hemiarthroplasty
This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
Device: VerSys Beaded FullCoat, Zimmer
The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN,

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114646


Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Hartford Hospital
Zimmer Biomet
Investigators
Study Director: Joseph P. DeAngelis, MD Hartford Hospital
Principal Investigator: Courtland G. Lewis, MD Hartford Hospital
  More Information

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01114646     History of Changes
Other Study ID Numbers: 03001334HU
124013 ( Other Identifier: Hartford Hospital IRB )
First Submitted: April 29, 2010
First Posted: May 3, 2010
Last Update Posted: February 10, 2012
Last Verified: January 2012

Keywords provided by Hartford Hospital:
Hemiarthroplasty
Cemented
Press Fit
Mortality
Morbidity
Functional Status
Displaced femoral neck fracture

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries