A Study to Determine the Difference in Low Contact Stress (LCS) Duofix Versus Low LCS Porocoat Knee Systems

Not Applicable

Completed

Conditions: Osteoarthritis

Registration Number: NCT00733499

Lead Sponsor: DePuy International

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 206

Inclusion Criteria

Male or female subjects.
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Subjects who present with idiopathic osteoarthritis, rheumatoid arthritis, post traumatic arthritis or any other pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty and who are considered suitable for treatment with a cementless mobile bearing knee system (LCS Complete).
Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with both the investigational devices, according to the indications specified in the package insert leaflet.

Exclusion Criteria

Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
Subjects with a known history of poor compliance to medical treatment.
Women who are pregnant.
Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
Subjects involved in Medical-Legal claims.
Subjects who have participated in a clinical study with an investigational product in the last month.
Subjects who are currently involved in any injury litigation claims.
Revision of an existing knee implant.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.	12 Months Post Surgery	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

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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.
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.	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.
Number of Participants With Tibial Radiolucency, Greater Than 2mm	3 months to 120 months	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.
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.	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.
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.	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.
Survivorship Analysis	9.99 years	The survival of each group is assessed using Kaplan-Meier curves. Revision for any reason constitutes an event.
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.	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.
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.	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.
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.	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.
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.	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.
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.	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.
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.	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.
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.	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.
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.	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.
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.	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.
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.	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.
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.	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.
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.	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.
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.	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.
Number of Participants With Tibial Radiolucency, 1mm-2mm	3 months to 120 months	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.
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.	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.
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.	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.
Number of Participants With Tibial Radiolucency, 0-1mm	3 months to 120 months	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.
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.	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.