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

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.
ClinicalTrials.gov Identifier: NCT00588861
Recruitment Status : Terminated (Study was terminated due to insufficient data and lack of patient follow-up)
First Posted : January 9, 2008
Results First Posted : January 26, 2012
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Osteoarthritis, Hip
Traumatic Arthritis of Hip
Intervention Device: Answer® hip stem
Enrollment 400
Recruitment Details Patients were recruited by the investigator based on the FDA cleared inclusion/exclusion criteria in the protocol.
Pre-assignment Details The patients were assigned to each group according to the bone cement used with the implant.
Arm/Group Title Answer Stem Utilizing Simplex Cement Answer Stem Utilizing Palacos Cement
Hide Arm/Group Description Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
Period Title: Pre-Operative
Started 202 [1] 200 [2]
Completed 107 114
Not Completed 95 86
Reason Not Completed
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 Title: 6 Months
Started 107 [1] 114 [2]
Completed 9 41
Not Completed 98 73
Reason Not Completed
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 Title: 1 Year
Started 107 [1] 114 [2]
Completed 18 32
Not Completed 89 82
Reason Not Completed
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 Title: 2 Years
Started 107 [1] 114 [2]
Completed 15 27
Not Completed 92 87
Reason Not Completed
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 Title: 4 Years
Started 107 [1] 114 [2]
Completed 16 11
Not Completed 91 103
Reason Not Completed
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 Title: 6 Years
Started 107 [1] 114 [2]
Completed 3 5
Not Completed 104 109
Reason Not Completed
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 Title: 8 Years
Started 107 [1] 114 [2]
Completed 2 0
Not Completed 105 114
Reason Not Completed
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 Title: 10 Years
Started 107 [1] 114 [2]
Completed 0 0
Not Completed 107 114
Reason Not Completed
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.
Arm/Group Title Answer Stem Utilizing Simplex Cement Answer Stem Utilizing Palacos Cement Total
Hide Arm/Group Description Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics 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 of all reporting groups
Overall Number of Baseline Participants 202 200 402
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 202 participants 200 participants 402 participants
73
(46 to 93)
76
(54 to 95)
75
(46 to 95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 200 participants 402 participants
Female
127
  62.9%
142
  71.0%
269
  66.9%
Male
75
  37.1%
58
  29.0%
133
  33.1%
1.Primary Outcome
Title Harris Hip Score
Hide Description The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent." 80-89 is considered "Good." 70-79 is considered "Fair." Less than 70 is considered "Poor."
Time Frame 10 Years Post-Operative
Hide Outcome Measure Data
Hide Analysis Population Description
This population represents patients that returned for follow-up per protocol. Because no patients returned at the primary outcome measure time frame (10 years), 0 patients were analyzed at 10 years.
Arm/Group Title Answer Stem Utilizing Simplex Cement Answer Stem Utilizing Palacos Cement
Hide Arm/Group Description:
Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Harris Hip Score Pain
Hide Description Harris Hip Score Pain is detailed below as mean score for the Harris Hip Score Pain question. 44 being the highest score, and 0 being the lowest score. 44 is considered "None/Ignores." 40 is considered "Slight/Occasional." 30 is considered "Mild." 20 is considered "Moderate." 10 is considered "Marked." 0 is considered "Totally Disabled."
Time Frame Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year
Hide Outcome Measure Data
Hide Analysis Population Description
This population represents patients that returned for follow-up per protocol.
Arm/Group Title Answer Stem Utilizing Simplex Cement Answer Stem Utilizing Palacos Cement
Hide Arm/Group Description:
Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
Overall Number of Participants Analyzed 202 200
Mean (Standard Deviation)
Unit of Measure: Mean Hip Pain
Pre-Operative Harris Hip Score Pain 15.89  (7.64) 14.74  (7.78)
6 Month Harris Hip Score Pain 39.78  (4.06) 36.25  (9.69)
1 Year Harris Hip Score Pain 37.89  (9.54) 37.76  (9.24)
2 Year Harris Hip Score Pain 36.93  (9.47) 34.59  (10.54)
4 Year Harris Hip Score Pain 38.38  (9.78) 41.27  (4.22)
6 Year Harris Hip Score Pain 44.00  (0) 42.00  (2.83)
8 Year Harris Hip Score Pain 37.00  (9.90) NA [1]   (NA)
[1]
No patients were analyzed at this time interval
Time Frame 8 Years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Answer Stem Utilizing Simplex Cement Answer Stem Utilizing Palacos Cement
Hide Arm/Group Description Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
All-Cause Mortality
Answer Stem Utilizing Simplex Cement Answer Stem Utilizing Palacos Cement
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Answer Stem Utilizing Simplex Cement Answer Stem Utilizing Palacos Cement
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/202 (7.43%)      8/200 (4.00%)    
Cardiac disorders     
Myocardial infarction *  1/202 (0.50%)  1 0/200 (0.00%)  0
Infections and infestations     
Deep infection < 6 weeks *  1/202 (0.50%)  1 2/200 (1.00%)  2
Deep infection > 6 weeks *  1/202 (0.50%)  1 1/200 (0.50%)  1
Musculoskeletal and connective tissue disorders     
Dislocation *  9/202 (4.46%)  31 1/200 (0.50%)  1
Femoral loosening *  2/202 (0.99%)  2 0/200 (0.00%)  0
Femoral, acetabular loosening and instability *  0/202 (0.00%)  0 1/200 (0.50%)  1
Surgical and medical procedures     
Revision with all components removed and re-implantation *  0/202 (0.00%)  0 2/200 (1.00%)  2
I&D, exchange of poly liner *  0/202 (0.00%)  0 1/200 (0.50%)  1
Vascular disorders     
Stroke *  1/202 (0.50%)  1 0/200 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Answer Stem Utilizing Simplex Cement Answer Stem Utilizing Palacos Cement
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/202 (0.00%)      0/200 (0.00%)    
Study was terminated prematurely after sponsor no longer distributed the products involved and follow-up failed to produce sufficient data to be analyzed.
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 only disclosure restriction on the PI is that the sponsor can conduct a pre-publication review of articles, papers, or presentations which the PI desires to publish. Any such review must be completed by sponsor within thirty (30)days of the submission of the request. The PI must include whatever credits the sponsor deems necessary or appropriate to disclose its proprietary interest to the material disclosed in the article, paper or presentation.
Results Point of Contact
Name/Title: Nick Higdon, Clinical Research Specialist
Organization: Biomet Manufacturing
Phone: 1-800-348-9500 ext 3047
Responsible Party: Zimmer Biomet ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00588861     History of Changes
Other Study ID Numbers: 101-U-011
First Submitted: December 19, 2007
First Posted: January 9, 2008
Results First Submitted: June 14, 2010
Results First Posted: January 26, 2012
Last Update Posted: January 27, 2017