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Trial record 41 of 119 for:    ZIRCONIUM

Evaluation of the Safety and Effectiveness of the Kinamed Gem Ceramic Femoral Component for Total Knee Replacement

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: NCT00743717
Recruitment Status : Completed
First Posted : August 29, 2008
Results First Posted : May 22, 2013
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
Kinamed Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Knee Osteoarthritis
Interventions Device: zirconia femoral component
Device: cobalt chrome femoral component
Enrollment 4
Recruitment Details Recruited during pre-op TKA clinical exam during year 2004.
Pre-assignment Details  
Arm/Group Title 1: Zirconia Femoral 2: CoCr Femoral
Hide Arm/Group Description zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
Period Title: Overall Study
Started 2 2
Completed 2 2
Not Completed 0 0
Arm/Group Title 1: Zirconia Femoral 2: CoCr Femoral Total
Hide Arm/Group Description zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  50.0%
0
   0.0%
1
  25.0%
>=65 years
1
  50.0%
2
 100.0%
3
  75.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 4 participants
62.5  (13.4) 65.5  (4.94) 64  (8.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
2
 100.0%
1
  50.0%
3
  75.0%
Male
0
   0.0%
1
  50.0%
1
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2 2 4
1.Primary Outcome
Title Knee Score at 2 Years Post Operation
Hide Description The criterion used to assess the outcome is a Knee Score (as defined by Knee Society Clinical Rating System) > 80 points at two-years follow-up. This scoring system is defined in the following paper: Insall JN, Dorr LD, Scott RD, and Scott WN (1989). Rationale of the Knee Society clinical rating system. Clin Orthop(248): 13-4. The scale ranges from minimum of 0 (worst) to maximum of 100 (best). Knee Score > 80 was used as a criterion to assess "success".
Time Frame within 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1: Zirconia Femoral 2: CoCr Femoral
Hide Arm/Group Description:
zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
Overall Number of Participants Analyzed 2 2
Mean (Full Range)
Unit of Measure: units on a scale
91
(85 to 97)
89
(88 to 90)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1: Zirconia Femoral 2: CoCr Femoral
Hide Arm/Group Description zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
All-Cause Mortality
1: Zirconia Femoral 2: CoCr Femoral
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1: Zirconia Femoral 2: CoCr Femoral
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1: Zirconia Femoral 2: CoCr Femoral
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Perry Secor
Organization: Los Alamitos Orthopaedic Group
Phone: 805-384-2748
EMail: vsarin@kinamed.com
Layout table for additonal information
Responsible Party: Kinamed Incorporated
ClinicalTrials.gov Identifier: NCT00743717     History of Changes
Other Study ID Numbers: G010204
First Submitted: August 27, 2008
First Posted: August 29, 2008
Results First Submitted: February 27, 2013
Results First Posted: May 22, 2013
Last Update Posted: May 27, 2013