Trial Outcomes & Findings for A Study to Determine the Difference in Low Contact Stress (LCS) Duofix Versus Low LCS Porocoat Knee Systems (NCT NCT00733499)
NCT ID: NCT00733499
Last Updated: 2020-01-14
Results Overview
The visual analog scale (VAS) pain score asks the subject to place a vertical mark anywhere on a horizontal line (that is approximately 10 cm long) with 'No pain' listed on the left (scored as 0) and 'Very severe pain' labeled on the right (scored as 10). The subject is instructed to indicate the amount of pain they feel in their knee joint
COMPLETED
NA
206 participants
12 Months Post Surgery
2020-01-14
Participant Flow
The first patient was operated on 26 September 2006 and recruitment lasted for 28 months with the last patient operated on 20th January 2009.
Consent was taken for 232 knees. 10 subjects were deemed unfit for surgery, 5 subjects were deemed ineligible for the study and 12 subjects were not randomised for the study. This left 205 subjects in the safety population that could be randomised for the study.
Participant milestones
| Measure |
LCS Complete Duofix
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Pre-operative
STARTED
|
102
|
103
|
|
Pre-operative
COMPLETED
|
102
|
102
|
|
Pre-operative
NOT COMPLETED
|
0
|
1
|
|
3 Months Follow-up
STARTED
|
102
|
102
|
|
3 Months Follow-up
COMPLETED
|
101
|
100
|
|
3 Months Follow-up
NOT COMPLETED
|
1
|
2
|
|
6 Months Follow-up
STARTED
|
101
|
100
|
|
6 Months Follow-up
COMPLETED
|
101
|
97
|
|
6 Months Follow-up
NOT COMPLETED
|
0
|
3
|
|
12 Months Follow-up
STARTED
|
101
|
97
|
|
12 Months Follow-up
COMPLETED
|
99
|
96
|
|
12 Months Follow-up
NOT COMPLETED
|
2
|
1
|
|
24 Months Follow-up
STARTED
|
99
|
96
|
|
24 Months Follow-up
COMPLETED
|
99
|
95
|
|
24 Months Follow-up
NOT COMPLETED
|
0
|
1
|
|
5 Year Followup
STARTED
|
91
|
78
|
|
5 Year Followup
COMPLETED
|
70
|
53
|
|
5 Year Followup
NOT COMPLETED
|
21
|
25
|
|
10 Year Followup
STARTED
|
46
|
32
|
|
10 Year Followup
COMPLETED
|
26
|
13
|
|
10 Year Followup
NOT COMPLETED
|
20
|
19
|
Reasons for withdrawal
| Measure |
LCS Complete Duofix
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Pre-operative
Protocol Violation
|
0
|
1
|
|
3 Months Follow-up
Death
|
1
|
2
|
|
6 Months Follow-up
Death
|
0
|
2
|
|
6 Months Follow-up
Adverse Event
|
0
|
1
|
|
12 Months Follow-up
Death
|
2
|
1
|
|
24 Months Follow-up
Death
|
0
|
1
|
|
5 Year Followup
Adverse Event
|
2
|
2
|
|
5 Year Followup
Non device related AE
|
0
|
1
|
|
5 Year Followup
Revision of Study Implant
|
0
|
1
|
|
5 Year Followup
Lost to Follow-up
|
2
|
0
|
|
5 Year Followup
Death
|
13
|
19
|
|
5 Year Followup
missing, unable to locate
|
0
|
1
|
|
5 Year Followup
Withdrawal by Subject
|
4
|
1
|
|
10 Year Followup
Death
|
9
|
7
|
|
10 Year Followup
Adverse Event
|
3
|
3
|
|
10 Year Followup
Lost to Follow-up
|
3
|
2
|
|
10 Year Followup
Withdrawal by Subject
|
5
|
5
|
|
10 Year Followup
missing, unable to locate
|
0
|
2
|
Baseline Characteristics
A Study to Determine the Difference in Low Contact Stress (LCS) Duofix Versus Low LCS Porocoat Knee Systems
Baseline characteristics by cohort
| Measure |
LCS Complete Duofix
n=102 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=102 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.39 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
70.49 years
STANDARD_DEVIATION 8.97 • n=7 Participants
|
70.94 years
STANDARD_DEVIATION 8.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Region of Enrollment
Ireland · Ireland
|
102 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 Months Post SurgeryPopulation: The number of participants analysed is based on the number of case report forms measuring the VAS pain score that we have in our database at the 12 month time point.
The visual analog scale (VAS) pain score asks the subject to place a vertical mark anywhere on a horizontal line (that is approximately 10 cm long) with 'No pain' listed on the left (scored as 0) and 'Very severe pain' labeled on the right (scored as 10). The subject is instructed to indicate the amount of pain they feel in their knee joint
Outcome measures
| Measure |
LCS Complete Duofix
n=87 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=87 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.
|
2.51 units on a scale
Standard Deviation 2.226
|
2.53 units on a scale
Standard Deviation 2.166
|
SECONDARY outcome
Timeframe: Pre-opPopulation: The number of participants analysed is based on the number of case report forms measuring the Oxford Knee Score that we have in our database at the preop time point.
The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.
Outcome measures
| Measure |
LCS Complete Duofix
n=102 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=102 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at Pre-op.
|
45.81 units on a scale
Standard Deviation 4.393
|
45.40 units on a scale
Standard Deviation 5.357
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the Oxford Knee Score that we have in our database at the preop time point.
The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.
Outcome measures
| Measure |
LCS Complete Duofix
n=96 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=92 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 3 Months.
|
28.66 units on a scale
Standard Deviation 8.993
|
29.45 units on a scale
Standard Deviation 8.224
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the Oxford Knee Score that we have in our database at the preop time point.
The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.
Outcome measures
| Measure |
LCS Complete Duofix
n=87 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=87 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.
|
25.16 units on a scale
Standard Deviation 6.963
|
26.10 units on a scale
Standard Deviation 6.429
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the Oxford Knee Score that we have in our database at the preop time point.
The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.
Outcome measures
| Measure |
LCS Complete Duofix
n=97 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=93 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.
|
24.70 units on a scale
Standard Deviation 8.341
|
27.17 units on a scale
Standard Deviation 9.022
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the Oxford Knee Score that we have in our database at the preop time point.
The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.
Outcome measures
| Measure |
LCS Complete Duofix
n=99 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=94 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 24 Months.
|
23.39 units on a scale
Standard Deviation 7.783
|
25.68 units on a scale
Standard Deviation 9.172
|
SECONDARY outcome
Timeframe: 60 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the Oxford Knee Score that we have in our database at the preop time point.
The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.
Outcome measures
| Measure |
LCS Complete Duofix
n=80 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=75 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 60 Months.
|
24.05 units on a scale
Standard Deviation 8.322
|
27.25 units on a scale
Standard Deviation 10.145
|
SECONDARY outcome
Timeframe: 120 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the Oxford Knee Score that we have in our database at the preop time point.
The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.
Outcome measures
| Measure |
LCS Complete Duofix
n=49 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=37 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 120 Months.
|
22.04 units on a scale
Standard Deviation 7.514
|
25.49 units on a scale
Standard Deviation 10.197
|
SECONDARY outcome
Timeframe: pre-opPopulation: The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
LCS Complete Duofix
n=13 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=16 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at Pre-op.
|
47.39 units on a scale
Standard Deviation 9.464
|
47.54 units on a scale
Standard Deviation 8.084
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
LCS Complete Duofix
n=38 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=34 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 3 Months.
|
49.87 units on a scale
Standard Deviation 9.931
|
48.21 units on a scale
Standard Deviation 9.784
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
LCS Complete Duofix
n=39 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=35 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.
|
52.54 units on a scale
Standard Deviation 9.532
|
51.99 units on a scale
Standard Deviation 9.261
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
LCS Complete Duofix
n=66 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=67 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.
|
51.60 units on a scale
Standard Deviation 10.905
|
49.83 units on a scale
Standard Deviation 10.022
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
LCS Complete Duofix
n=78 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=79 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 24 Months.
|
52.88 units on a scale
Standard Deviation 8.597
|
52.81 units on a scale
Standard Deviation 8.662
|
SECONDARY outcome
Timeframe: 60 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
LCS Complete Duofix
n=72 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=65 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 60 Months.
|
49.87 units on a scale
Standard Deviation 11.395
|
47.38 units on a scale
Standard Deviation 11.757
|
SECONDARY outcome
Timeframe: 120 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
LCS Complete Duofix
n=49 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=37 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 120 Months.
|
54.85 units on a scale
Standard Deviation 7.877
|
53.49 units on a scale
Standard Deviation 9.821
|
SECONDARY outcome
Timeframe: 5 YearsThe survival of each group is assessed using Kaplan-Meier curves. Revision for any reason constitutes an event.
Outcome measures
| Measure |
LCS Complete Duofix
n=90 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=81 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Survivorship Analysis
|
100 Percentage of Participants
Interval 100.0 to 100.0
|
98.9 Percentage of Participants
Interval 92.1 to 99.8
|
SECONDARY outcome
Timeframe: 9.99 yearsPopulation: 10 Year survivorship could not be calculated due to N \<40 but could be calculated at 9.99 years.
The survival of each group is assessed using Kaplan-Meier curves. Revision for any reason constitutes an event.
Outcome measures
| Measure |
LCS Complete Duofix
n=38 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=34 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Survivorship Analysis
|
100 Percentage of Participants
Interval 100.0 to 100.0
|
98.9 Percentage of Participants
Interval 92.1 to 99.8
|
SECONDARY outcome
Timeframe: preopPopulation: The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
LCS Complete Duofix
n=13 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=16 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at Preop.
|
30.8 units on a scale
Standard Deviation 6.085
|
24.81 units on a scale
Standard Deviation 3.089
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
LCS Complete Duofix
n=38 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=34 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 3 Months.
|
35.50 units on a scale
Standard Deviation 8.927
|
34.64 units on a scale
Standard Deviation 9.171
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
LCS Complete Duofix
n=39 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=35 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.
|
36.58 units on a scale
Standard Deviation 8.411
|
33.31 units on a scale
Standard Deviation 8.800
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
LCS Complete Duofix
n=66 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=67 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.
|
36.76 units on a scale
Standard Deviation 9.353
|
36.56 units on a scale
Standard Deviation 9.346
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
LCS Complete Duofix
n=78 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=79 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 24 Months.
|
37.41 units on a scale
Standard Deviation 10.577
|
37.49 units on a scale
Standard Deviation 9.693
|
SECONDARY outcome
Timeframe: 60 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
LCS Complete Duofix
n=72 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=65 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 60 Months.
|
36.52 units on a scale
Standard Deviation 10.802
|
32.93 units on a scale
Standard Deviation 10.259
|
SECONDARY outcome
Timeframe: 120 monthsPopulation: The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
LCS Complete Duofix
n=49 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=37 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 120 Months.
|
40.73 units on a scale
Standard Deviation 10.465
|
40.78 units on a scale
Standard Deviation 10.701
|
SECONDARY outcome
Timeframe: 3 months to 120 monthsPopulation: Subjects within safety population with complete, available data.
Zonal Analysis of the 6 zones of the tibial component was determined from the post operative radiographs. Osteo-fixation was graded using the following system 0-1 mm radiolucencies will be classed as fixated, 1-2mm not fixated, \>2mm unstable.
Outcome measures
| Measure |
LCS Complete Duofix
n=102 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=102 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Number of Participants With Tibial Radiolucency, 0-1mm
3 months
|
13 Participants
|
20 Participants
|
|
Number of Participants With Tibial Radiolucency, 0-1mm
12 months
|
14 Participants
|
27 Participants
|
|
Number of Participants With Tibial Radiolucency, 0-1mm
60 months
|
14 Participants
|
18 Participants
|
|
Number of Participants With Tibial Radiolucency, 0-1mm
120 months
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 3 months to 120 monthsPopulation: Subjects within safety population with complete, available data.
Zonal Analysis of the 6 zones of the tibial component was determined from the post operative radiographs. Osteo-fixation was graded using the following system 0-1 mm radiolucencies will be classed as fixated, 1-2mm not fixated, \>2mm unstable.
Outcome measures
| Measure |
LCS Complete Duofix
n=102 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=102 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Number of Participants With Tibial Radiolucency, 1mm-2mm
3 months
|
13 Participants
|
20 Participants
|
|
Number of Participants With Tibial Radiolucency, 1mm-2mm
12 months
|
14 Participants
|
31 Participants
|
|
Number of Participants With Tibial Radiolucency, 1mm-2mm
60 months
|
21 Participants
|
32 Participants
|
|
Number of Participants With Tibial Radiolucency, 1mm-2mm
120 months
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 3 months to 120 monthsPopulation: Subjects within safety population with complete, available data.
Zonal Analysis of the 6 zones of the tibial component was determined from the post operative radiographs. Osteo-fixation was graded using the following system 0-1 mm radiolucencies will be classed as fixated, 1-2mm not fixated, \>2mm unstable.
Outcome measures
| Measure |
LCS Complete Duofix
n=102 Participants
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=102 Participants
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Number of Participants With Tibial Radiolucency, Greater Than 2mm
3 months
|
3 Participants
|
6 Participants
|
|
Number of Participants With Tibial Radiolucency, Greater Than 2mm
12 months
|
3 Participants
|
5 Participants
|
|
Number of Participants With Tibial Radiolucency, Greater Than 2mm
60 months
|
5 Participants
|
6 Participants
|
|
Number of Participants With Tibial Radiolucency, Greater Than 2mm
120 months
|
1 Participants
|
1 Participants
|
Adverse Events
LCS Complete Duofix
LCS Complete Porocoat
Serious adverse events
| Measure |
LCS Complete Duofix
n=102 participants at risk
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=103 participants at risk
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Cardiac disorders
Cardiac Disorder
|
4.9%
5/102 • Number of events 6 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
7.8%
8/103 • Number of events 9 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/102 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
1.9%
2/103 • Number of events 4 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
|
Infections and infestations
Infections and infestations
|
9.8%
10/102 • Number of events 12 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
8.7%
9/103 • Number of events 11 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
|
General disorders
General disorders and administration site conditions
|
4.9%
5/102 • Number of events 6 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
5.8%
6/103 • Number of events 6 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
6.9%
7/102 • Number of events 14 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
9.7%
10/103 • Number of events 18 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
|
Investigations
Investigations
|
0.98%
1/102 • Number of events 1 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
0.97%
1/103 • Number of events 1 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
22.5%
23/102 • Number of events 34 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
26.2%
27/103 • Number of events 34 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.00%
0/102 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
2.9%
3/103 • Number of events 3 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
10.8%
11/102 • Number of events 13 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
8.7%
9/103 • Number of events 12 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
|
Nervous system disorders
Nervous System disorders
|
6.9%
7/102 • Number of events 7 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
9.7%
10/103 • Number of events 11 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.00%
0/102 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
1.9%
2/103 • Number of events 2 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
4.9%
5/102 • Number of events 5 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
0.97%
1/103 • Number of events 1 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
|
Vascular disorders
Vascular disorders
|
0.98%
1/102 • Number of events 1 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
0.97%
1/103 • Number of events 1 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
Other adverse events
| Measure |
LCS Complete Duofix
n=102 participants at risk
LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
|
LCS Complete Porocoat
n=103 participants at risk
LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
16.7%
17/102 • Number of events 50 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
16.5%
17/103 • Number of events 61 • All participants had reached the 10 year follow-up visit at the time of uploading adverse events
Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee DePuy reserves the right to review the contents of publications in advance.The PI may freely disclose the trial results only after DePuy has been given the opportunity of reviewing the proposed results communications at least 30 days prior to the intended release.DePuy will advise the PI of any perceived errors,omissions or corrections but the PI will retain final editorial control.In case of disagreement,DePuy and the PI will make every effort to meet in order to discuss and resolve any issues.
- Publication restrictions are in place
Restriction type: OTHER