Sponsor study identifier
interventional
4
0 countries
N/A
Study Start
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)The aim of this study is to provide evidence that the safety and effectiveness of the ceramic femoral component of the Gem Total Knee System is similar to FDA approved implants used in total knee replacement surgery. The hypotheses to be tested are that the investigational and control groups are equivalent in terms of patient success rate and complication-free rate.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
August 27, 2008
Actual (reported)August 29, 2008
Actual (reported)December 2012
Actual (reported)December 2012
Actual (reported)May 22, 2013
Actual (reported)Knee Score at 2 Years Post Operation
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".
within 2 years
total knee arthroplasty performed using implant with zirconia femoral component
total knee arthroplasty performed using implant with cobalt chrome femoral component
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Vineet Sarin, PhD
Kinamed Incorporated
4 participants (actual enrollment reported by the registry).
First Submitted
August 27, 2008
First Posted
August 29, 2008
Study Start
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
May 27, 2013
Results First Posted
May 22, 2013
Record last verified: 2013-05
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Source: ClinicalTrials.gov.
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