Trial Outcomes & Findings for Evaluation of the Safety and Effectiveness of the Kinamed Gem Ceramic Femoral Component for Total Knee Replacement (NCT NCT00743717)

Last Updated: 2013-05-27

Results Overview

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".

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

within 2 years

Results posted on

2013-05-27

Participant Flow

Recruited during pre-op TKA clinical exam during year 2004.

Participant milestones

Participant milestones
Measure	1: Zirconia Femoral zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component	2: CoCr Femoral cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1: Zirconia Femoral n=2 Participants zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component	2: CoCr Femoral n=2 Participants cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age Continuous	62.5 years STANDARD_DEVIATION 13.4 • n=5 Participants	65.5 years STANDARD_DEVIATION 4.94 • n=7 Participants	64 years STANDARD_DEVIATION 8.45 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: within 2 years

Outcome measures

Outcome measures
Measure	1: Zirconia Femoral n=2 Participants zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component	2: CoCr Femoral n=2 Participants cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
Knee Score at 2 Years Post Operation	91 units on a scale Interval 85.0 to 97.0	89 units on a scale Interval 88.0 to 90.0

Adverse Events

1: Zirconia Femoral

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2: CoCr Femoral

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Perry Secor

Los Alamitos Orthopaedic Group

Phone: 805-384-2748

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place