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

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ClinicalTrials.gov Identifier: NCT01114646
Recruitment Status : Completed
First Posted : May 3, 2010
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Hartford Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Femoral Neck Fracture
Interventions Device: Cemented Hip Hemiarthroplasty
Device: VerSys Beaded FullCoat, Zimmer
Enrollment 130
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cemented Hip Hemiarthroplasty Press-Fit Hip Hemiarthroplasty
Hide Arm/Group Description This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN). This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
Period Title: Overall Study
Started 66 64
Completed 63 62
Not Completed 3 2
Reason Not Completed
Withdrawal by Subject             3             2
Arm/Group Title Cemented Hip Hemiarthroplasty Press-Fit Hip Hemiarthroplasty Total
Hide Arm/Group Description This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN). This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN), Total of all reporting groups
Overall Number of Baseline Participants 66 64 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 64 participants 130 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
66
 100.0%
64
 100.0%
130
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 64 participants 130 participants
81.8  (9.0) 82.8  (7.6) 82.3  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 64 participants 130 participants
Female
52
  78.8%
48
  75.0%
100
  76.9%
Male
14
  21.2%
16
  25.0%
30
  23.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 66 participants 64 participants 130 participants
66 64 130
1.Primary Outcome
Title Mortality
Hide Description Assessment of post-operative mortality at one-year.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cemented Hip Hemiarthroplasty Press-Fit Hip Hemiarthroplasty
Hide Arm/Group Description:
This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).
This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
Overall Number of Participants Analyzed 66 64
Measure Type: Number
Unit of Measure: pecent
23.1 20.1
2.Primary Outcome
Title Post-Operative Unstable Angina
Hide Description 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.
Time Frame 1 week post-operation
Outcome Measure Data Not Reported
3.Primary Outcome
Title Post-Operative Myocardial Infarction
Hide Description Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.
Time Frame 1 week post-operation
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) Scale
Hide Description 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.
Time Frame 1 year
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Energy/Fatigue Scale
Hide Description An inquire about fatigue, level of energy and self-efficiency.
Time Frame 1 year
Outcome Measure Data Not Reported
Time Frame Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days.
Adverse Event Reporting Description other events such pneumonia, wound infection, thromboembolic event, cerebrovascular accident major hemorrhage will be assessed by concurrent medical record review. Hospital outcome will be assessed by surgical and medical team. Functional outcome will be completed over the telephone (self-reported)
 
Arm/Group Title Cemented Hip Hemiarthroplasty Press-Fit Hip Hemiarthroplasty
Hide Arm/Group Description This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN). This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
All-Cause Mortality
Cemented Hip Hemiarthroplasty Press-Fit Hip Hemiarthroplasty
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cemented Hip Hemiarthroplasty Press-Fit Hip Hemiarthroplasty
Affected / at Risk (%) Affected / at Risk (%)
Total   1/66 (1.52%)   1/64 (1.56%) 
Cardiac disorders     
Death   1/66 (1.52%)  1/64 (1.56%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Cemented Hip Hemiarthroplasty Press-Fit Hip Hemiarthroplasty
Affected / at Risk (%) Affected / at Risk (%)
Total   11/66 (16.67%)   8/64 (12.50%) 
Cardiac disorders     
Myocardial Infarction   2/66 (3.03%)  1/64 (1.56%) 
General disorders     
ICU stay   4/66 (6.06%)  5/64 (7.81%) 
Infections and infestations     
Wound Infection   1/66 (1.52%)  1/64 (1.56%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia   3/66 (4.55%)  1/64 (1.56%) 
Surgical and medical procedures     
Re-operation   1/66 (1.52%)  0/64 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Arben Ademi, CCRP
Organization: Hartford Hostpial
Phone: 860-972-3561
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
Results First Submitted: March 21, 2013
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018