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

This study has been completed.
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01114646
First received: April 29, 2010
Last updated: February 9, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Hartford Hospital:

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

  • Post-Operative Unstable Angina [ Time Frame: 1 week post-operation ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114646

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

No publications provided

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01114646     History of Changes
Other Study ID Numbers: 03001334HU, 124013
Study First Received: April 29, 2010
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 18, 2013