Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement

This study has been terminated.
(Study was terminated due to insufficient data and lack of patient follow-up)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00588861
First received: December 19, 2007
Last updated: January 12, 2012
Last verified: January 2012
Results First Received: June 14, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Osteoarthritis, Hip
Traumatic Arthritis of Hip
Intervention: Device: Answer® hip stem

  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
Patients were recruited by the investigator based on the FDA cleared inclusion/exclusion criteria in the protocol.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The patients were assigned to each group according to the bone cement used with the implant.

Reporting Groups
  Description
Answer Stem Utilizing Simplex Cement Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
Answer Stem Utilizing Palacos Cement Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.

Participant Flow for 8 periods

Period 1:   Pre-Operative
    Answer Stem Utilizing Simplex Cement     Answer Stem Utilizing Palacos Cement  
STARTED     202 [1]   200 [2]
COMPLETED     107     114  
NOT COMPLETED     95     86  
Patients Did Not Complete Preop Data                 95                 86  
[1] 202 Patients were enrolled, however only 107 contributed preop data.
[2] 200 patients were enrolled, however only 114 contributed preop data.

Period 2:   6 Months
    Answer Stem Utilizing Simplex Cement     Answer Stem Utilizing Palacos Cement  
STARTED     107 [1]   114 [2]
COMPLETED     9     41  
NOT COMPLETED     98     73  
Patients did not return for follow-up                 98                 73  
[1] 107 cases were due at 6 Months, however only 9 returned for follow-up.
[2] 114 cases were due at 6 Months, however only 41 returned for follow-up.

Period 3:   1 Year
    Answer Stem Utilizing Simplex Cement     Answer Stem Utilizing Palacos Cement  
STARTED     107 [1]   114 [2]
COMPLETED     18     32  
NOT COMPLETED     89     82  
Patients did not return for follow-up                 89                 82  
[1] 107 cases were due at 1 Year, however only 18 returned for follow-up.
[2] 114 cases were due at 1 Year, however only 32 returned for follow-up.

Period 4:   2 Years
    Answer Stem Utilizing Simplex Cement     Answer Stem Utilizing Palacos Cement  
STARTED     107 [1]   114 [2]
COMPLETED     15     27  
NOT COMPLETED     92     87  
Patients did not return for follow-up                 92                 87  
[1] 107 cases were due at 2 Years, however only 15 returned for follow-up.
[2] 114 cases were due at 2 Years, however only 27 returned for follow-up.

Period 5:   4 Years
    Answer Stem Utilizing Simplex Cement     Answer Stem Utilizing Palacos Cement  
STARTED     107 [1]   114 [2]
COMPLETED     16     11  
NOT COMPLETED     91     103  
Patients did not return for follow-up                 91                 103  
[1] 107 cases were due at 4 Years, however only 16 returned for follow-up.
[2] 114 cases were due at 4 Years, however only 11 returned for follow-up.

Period 6:   6 Years
    Answer Stem Utilizing Simplex Cement     Answer Stem Utilizing Palacos Cement  
STARTED     107 [1]   114 [2]
COMPLETED     3     5  
NOT COMPLETED     104     109  
Patients did not return for follow-up                 104                 109  
[1] 107 cases were due at 6 Years, however only 3 returned for follow-up.
[2] 114 cases were due at 6 Years, however only 5 returned for follow-up.

Period 7:   8 Years
    Answer Stem Utilizing Simplex Cement     Answer Stem Utilizing Palacos Cement  
STARTED     107 [1]   114 [2]
COMPLETED     2     0  
NOT COMPLETED     105     114  
Patients did not return for follow-up                 105                 114  
[1] 107 cases were due at 8 Years, however only 2 returned for follow-up.
[2] 114 cases were due at 8 Years, however no patients returned for follow-up.

Period 8:   10 Years
    Answer Stem Utilizing Simplex Cement     Answer Stem Utilizing Palacos Cement  
STARTED     107 [1]   114 [2]
COMPLETED     0     0  
NOT COMPLETED     107     114  
Incomplete due to study termination                 107                 114  
[1] 107 cases were due at 10 Years, however no patients returned for follow-up.
[2] 114 cases were due at 10 Years, however no patients returned for follow-up.



  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
Answer Stem Utilizing Simplex Cement Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
Answer Stem Utilizing Palacos Cement Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
Total Total of all reporting groups

Baseline Measures
    Answer Stem Utilizing Simplex Cement     Answer Stem Utilizing Palacos Cement     Total  
Number of Participants  
[units: participants]
  202     200     402  
Age  
[units: years]
Mean ( Full Range )
  73  
  ( 46 to 93 )  
  76  
  ( 54 to 95 )  
  75  
  ( 46 to 95 )  
Gender  
[units: participants]
     
Female     127     142     269  
Male     75     58     133  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Harris Hip Score   [ Time Frame: 10 Years Post-Operative ]

2.  Secondary:   Harris Hip Score Pain   [ Time Frame: Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year ]


  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
Study was terminated prematurely after sponsor no longer distributed the products involved and follow-up failed to produce sufficient data to be analyzed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Nick Higdon, Clinical Research Specialist
Organization: Biomet Manufacturing
phone: 1-800-348-9500 ext 3047
e-mail: nicholas.higdon@biomet.com


No publications provided


Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00588861     History of Changes
Other Study ID Numbers: 101-U-011
Study First Received: December 19, 2007
Results First Received: June 14, 2010
Last Updated: January 12, 2012
Health Authority: United States: Institutional Review Board