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Evaluation of the Trabecular Metal™ Revision Hip Cup Using Bone Mineral Density (DEXA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01183260
First Posted: August 17, 2010
Last Update Posted: November 7, 2017
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):
Wael Barsoum, The Cleveland Clinic
Results First Submitted: September 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Revision, Joint
Interventions: Device: Trabecular Metal Revision Cup
Device: Trabecular Metal Modular Cup

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: 2010 - 2014

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Zimmer Trabecular Metal Acetabular Cup Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
Zimmer Modular Cup Zimmer Modular Cup: Revision of the acetabular cup

Participant Flow:   Overall Study
    Zimmer Trabecular Metal Acetabular Cup   Zimmer Modular Cup
STARTED   14   11 
COMPLETED   10   9 
NOT COMPLETED   4   2 
Intraop screen failure                2                0 
Withdrawal by Subject                1                1 
Revised within 30 days                0                1 
Death                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Zimmer Trabecular Metal Acetabular Cup Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
Zimmer Modular Cup Zimmer Modular Cup: Revision of the acetabular cup
Total Total of all reporting groups

Baseline Measures
   Zimmer Trabecular Metal Acetabular Cup   Zimmer Modular Cup   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   9   19 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 10   9   19 
   58.60  (11.40)   61.11  (9.74)   59.79  (10.15) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 10   9   19 
Female      4  40.0%      5  55.6%      9  47.4% 
Male      6  60.0%      4  44.4%      10  52.6% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 0   0   0 
         0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States       
Participants Analyzed 
[Units: Participants]
 10   9   19 
United States   10   9   19 
Operative Side: Left, Right 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 10   9   19 
Left      5  50.0%      5  55.6%      10  52.6% 
Right      5  50.0%      4  44.4%      9  47.4% 
BMI (kg/m^2), Continuous 
[Units: Kg/m^2]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 10   9   19 
   30.14  (6.07)   30.49  (7.56)   30.31  (6.44) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Periprosthetic Bone Mineral Density (BMD) of Hip   [ Time Frame: 2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 2 year postoperative ]

2.  Secondary:   Functional and General Health Outcome Assessments   [ Time Frame: 2 years postoperative; measured preoperatively and 3 months, 6 months, 1 year, 2 year postoperative ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
A large amount of variability was present in the data leading to reduced statistical power during hypothesis testing


  More Information
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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: Alison Klika, Research Program Manager
Organization: Cleveland Clinic
phone: 216-444-4954
e-mail: klikaa@ccf.org



Responsible Party: Wael Barsoum, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01183260     History of Changes
Other Study ID Numbers: ZIMM1007WB
09-859 ( Other Identifier: CCF IRB )
First Submitted: August 13, 2010
First Posted: August 17, 2010
Results First Submitted: September 11, 2017
Results First Posted: November 7, 2017
Last Update Posted: November 7, 2017