10003 PRO Current Products

Study Overview
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Brief Summary
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This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one of four contemporary knee configurations from different manufacturers will be pooled to establish a contemporary dataset. The primary objective of this study is to evaluate the functional performance as measured by the activities of daily living (ADL) sub-score of the Knee Osteoarthritis Outcomes Score (KOOS) patient-reported outcome (PRO) questionnaire of primary TKA at minimum one year post-operation. This will be carried out for all four implant configurations. The final endpoint is a 2-year evaluation.

Detailed Description
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The study is designed as a prospective, single arm stratified, multi-center investigation. Approximately 20 study sites, worldwide, will enroll 840 patients (840 knees). Each study site is expected to enroll approximately 42 patients (42 knees). Cohort reallocation is permitted. There will be no control group. Eight hundred forty (840) Subjects will be stratified into 4 subgroups of 210: fixed bearing cruciate retaining (FB CR), fixed bearing posterior stabilized (FB PS), rotating platform cruciate retaining (RP CR), and rotating platform posterior stabilized (RP PS). Treatment assignment in this study is not randomized. Each site will only enroll patients in one of the four knee configuration sub-groups most commonly used as their standard of care.

Official Title
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Multi-center, Non-comparative Study of Primary Total Knee Arthroplasty (TKA) Functional Performance

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Total Knee Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female and between the ages of 22 and 80 years, inclusive. Subject was diagnosed with NIDJD. Subject is a suitable candidate for cemented primary TKA using the devices described in this CIP with either a resurfaced or non-resurfaced patellae. Subject's TKA device was one of the total knee prostheses described under Interventions. Subject is currently not bedridden. Subject has given voluntary, written informed consent to participate in this clinical investigation, is willing and able to perform all study procedures and follow-up visits and has authorized the transfer of his/her information to DePuy. Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures. Subject must be comfortable with speaking, reading, and understanding questions and providing responses in English. The devices specified in this CIP were implanted. Exclusion Criteria: The Subject is a woman who is pregnant or lactating. Contralateral knee has already been enrolled in this study. Subject had a contralateral amputation. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee. Subject is currently experiencing radicular pain from the spine. Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires. Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication. Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease). Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.). Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP. Subject has a medical condition with less than 2 years of life expectancy.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CR FB<br>Subjects receiving a Cruciate Retaining Fixed Bearing implant configuration | Device: Total Knee Replacement<br>* Subjects will receive one of the following total knee implants: PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.<br>|
| PS FB<br>Subjects Receiving a Posterior Stabilized Fixed Bearing implant configuration | Device: Total Knee Replacement<br>* Subjects will receive one of the following total knee implants: PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.<br>|
| CR RP<br>Subjects receiving a Cruciate Retaining Rotating Platform implant configuration | Device: Total Knee Replacement<br>* Subjects will receive one of the following total knee implants: PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.<br>|
| PS RP<br>Subjects receiving a Posterior Stabilized Rotating Platform implant configuration | Device: Total Knee Replacement<br>* Subjects will receive one of the following total knee implants: PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score | The primary endpoint will be measuerd before surgery and out to a minimum of 1 year after surgery. The KOOS is a patient self-administered questionnaire that consists of 42 questions. The KOOS consists of 5 subscales; pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee-related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the psychometric properties of PKIP | The Pre and Post-Surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option. | Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) | 
| Evaluate the longitudinal functional performance of primary TKA |  | < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) | 
| Evaluate Incidence of Anterior Knee Pain |  | Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) | 
| Evaluate incidence of asymptomatic and symptomatic crepitus |  | Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) | 
| Evaluate patients functional performance for PS knees, CR knees, FB knees, and RP knees |  | < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Replacement, Knee,