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The primary objective of this investigation is to test the hypothesis that the Duofix Tibial component results in a reduction of immediate postoperative pain compared to the LCS Porocoat version.
The secondary objectives of this investigation are to evaluate the clinical and patient outcomes, biological fixation and survivorship associated with the LCS Duofix and Porocoat knee system over 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCS Complete Duofix | Other | 102 patients |
|
| LCS Complete Porocoat | Active Comparator | 104 patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCS Complete Duofix | Device | Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months. | 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 | 12 Months Post Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Musgrave Park Hospital | Belfast | BT9 7JB | Ireland |
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.
The first patient was operated on 26 September 2006 and recruitment lasted for 28 months with the last patient operated on 20th January 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | LCS Complete Duofix | LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces |
| FG001 | LCS Complete Porocoat | LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-operative |
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| 3 Months Follow-up |
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| 6 Months Follow-up |
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| 12 Months Follow-up |
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| 24 Months Follow-up |
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| 5 Year Followup |
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| 10 Year Followup |
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The number of participants in the intent to treat population (All eligible subjects, admitted to the study that receive the allocated treatment, and have at least one usable post-treatment assessment).
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| ID | Title | Description |
|---|---|---|
| BG000 | LCS Complete Duofix | LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces |
| BG001 | LCS Complete Porocoat | LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months. | 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 Months Post Surgery |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LCS Complete Duofix | LCS Complete Duofix patients : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Disorder | Cardiac disorders | MedDRA 16.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Reported as AEs and not SAEs. Final assessment of adverse events were classified by organ system class in lieu of specific adverse event terms. |
This is a single surgeon/site study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tamiko Magee-Rodgers, PhD | DePuy Ortho Joint US | TMageeRo@its.jnj.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| LCS Complete Porocoat | Device | Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces |
|
| Pre-op |
| 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. | 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. | 3 months |
| 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. | 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. | 6 months |
| 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. | 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. | 12 months |
| 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. | 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. | 24 months |
| 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. | 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. | 60 months |
| 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. | 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. | 120 months |
| 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. | 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. | pre-op |
| 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. | 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. | 3 months |
| 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. | 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. | 6 months |
| 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. | 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. | 12 months |
| 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. | 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. | 24 months |
| 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. | 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. | 60 months |
| 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. | 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. | 120 months |
| Survivorship Analysis | The survival of each group is assessed using Kaplan-Meier curves. Revision for any reason constitutes an event. | 5 Years |
| Survivorship Analysis | The survival of each group is assessed using Kaplan-Meier curves. Revision for any reason constitutes an event. | 9.99 years |
| 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. | 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. | preop |
| 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. | 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. | 3 months |
| 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. | 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. | 6 months |
| 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. | 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. | 12 months |
| 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. | 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. | 24 months |
| 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. | 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. | 60 months |
| 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. | 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. | 120 months |
| Number of Participants With Tibial Radiolucency, 0-1mm | 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. | 3 months to 120 months |
| Number of Participants With Tibial Radiolucency, 1mm-2mm | 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. | 3 months to 120 months |
| Number of Participants With Tibial Radiolucency, Greater Than 2mm | 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. | 3 months to 120 months |
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| BG002 | Total | Total of all reporting groups |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | LCS Complete Porocoat | LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-op |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 60 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 120 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | pre-op |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 60 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 120 months |
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| Secondary | Survivorship Analysis | The survival of each group is assessed using Kaplan-Meier curves. Revision for any reason constitutes an event. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 5 Years |
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| Secondary | Survivorship Analysis | The survival of each group is assessed using Kaplan-Meier curves. Revision for any reason constitutes an event. | 10 Year survivorship could not be calculated due to N <40 but could be calculated at 9.99 years. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 9.99 years |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | preop |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 60 months |
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 120 months |
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| Secondary | Number of Participants With Tibial Radiolucency, 0-1mm | 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. | Subjects within safety population with complete, available data. | Posted | Count of Participants | Participants | 3 months to 120 months |
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| Secondary | Number of Participants With Tibial Radiolucency, 1mm-2mm | 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. | Subjects within safety population with complete, available data. | Posted | Count of Participants | Participants | 3 months to 120 months |
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| Secondary | Number of Participants With Tibial Radiolucency, Greater Than 2mm | 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. | Subjects within safety population with complete, available data. | Posted | Count of Participants | Participants | 3 months to 120 months |
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| 27 |
| 102 |
| 58 |
| 102 |
| 17 |
| 102 |
| EG001 | LCS Complete Porocoat | LCS Complete Porocoat patients : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces | 33 | 103 | 68 | 103 | 17 | 103 |
| Gastrointestinal | Gastrointestinal disorders | MedDRA 16.0 |
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| Infections and infestations | Infections and infestations | MedDRA 16.0 |
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| General disorders and administration site conditions | General disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA 16.0 |
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| Investigations | Investigations | MedDRA 16.0 |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA 16.0 |
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| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 |
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| Nervous System disorders | Nervous system disorders | MedDRA 16.0 |
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| Renal and urinary disorders | Renal and urinary disorders | MedDRA 16.0 |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
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| Vascular disorders | Vascular disorders | MedDRA 16.0 |
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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.
| 12 months |
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| 60 months |
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| 120 months |
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| 12 months |
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| 60 months |
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| 120 months |
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| 12 months |
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| 60 months |
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| 120 months |
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