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

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

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.

Study Overview

• Status: Completed
• Conditions: Femoral Neck Fracture
• Intervention / Treatment: Device: Cemented Hip Hemiarthroplasty; Device: VerSys Beaded FullCoat, Zimmer

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Assessment of post-operative mortality at one-year.	1 year
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
Post-Operative Myocardial Infarction	Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.	1 week post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Energy/Fatigue Scale	An inquire about fatigue, level of energy and self-efficiency.	1 year

Collaborators and Investigators

• Sponsor: Hartford Hospital
• Collaborators: Zimmer Biomet
• Investigators: Study Director: Joseph P. DeAngelis, MD, Hartford Hospital; Principal Investigator: Courtland G. Lewis, MD, Hartford Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (ACTUAL): May 1, 2009
• Study Completion (ACTUAL): May 1, 2009

Study Registration Dates

• First Submitted: April 29, 2010
• First Submitted That Met QC Criteria: April 30, 2010
• First Posted (ESTIMATE): May 3, 2010

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Hemiarthroplasty; Morbidity; Mortality; Cemented; Functional Status; Press Fit; Displaced femoral neck fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: 03001334HU; 124013 (OTHER: Hartford Hospital IRB)