Evaluation of Post-Operative Recovery in ATTUNE® Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This post-marketing investigation will evaluate the rate of recovery of the ATTUNE knee from the time of surgery through the 6 month endpoint in patients with severely painful and/or severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD).

Detailed Description
-----------------
This study is designed as a prospective, multi-center, non-randomized, non-comparative, non-controlled study. A sample size of N=200 subjects will be implanted at up to 4 sites in the Netherlands. Each site is expected to implant approximately 50 Subjects (50 knees). This study allows the participating surgeon to choose the type of ATTUNE implant they would ordinarily use in standard practice. Both resurfaced patellae and non-resurfaced patellae are permitted in this investigation; consistent with the surgeons standard of care. Subjects will receive one of four available implants: cruciate retaining fixed bearing (CR FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS FB), and posterior stabilized rotating platform (PS RP).

Official Title
-----------------
Multi-Center Evaluation of Post-Operative Recovery in ATTUNE Primary, Cemented Total Knee Arthroplasty

Conditions
-----------------
Non-inflammatory Degenerative Joint Disease

Intervention / Treatment
-----------------
* Device: ATTUNE Primary, Cemented Total Knee Replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive. Subject was diagnosed with Non-inflammatory Degenerative Joint Disease (NIDJD). Subject is a suitable candidate for cemented primary total knee replacement (TKA) using the devices described in this protocol with either resurfaced or non-resurfaced patellae. Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to the study Sponsor. Subject is currently not bedridden Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow- up visits and co-operate with investigational procedures. Subject is able to speak, read, and comprehend the Informed Consent Document as well as complete the Patient Reported Outcomes Questionnaires required per the protocol in either Dutch or English translations. 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 that radiates into the limb to receive TKA. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia. Subject has a significant neurological or musculoskeletal disorder(s) 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 has a medical condition with less than 3 years of life expectancy.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ATTUNE Primary, Cemented Total Knee Replacement<br>Subjects will receive one of four available ATTUNE total knee implants: (CR FB, CR RP, PS FB, PS RP). | Device: ATTUNE Primary, Cemented Total Knee Replacement<br>* Patients will undergo a primary total knee replacement using one of the four implant configurations of the ATTUNE knee ( CR FB, CR RP, PS FB, PS RP).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS-PS change from baseline at 6 months post-operatively, as estimated from a repeated measurements longitudinal model over all post-operative time points. | The Knee Injury and Osteoarthritis Physical Function Short Form (KOOS-PS) will be used to measure knee function as a means of evaluating the rate of recovery. The (KOOS-PS) is a patient self-administered questionnaire. The questionnaire consists of 7 questions to evaluate function with activities of daily living (ADL) and higher level functioning activities (sport and recreational). Each question has 5 Likert-like response options. Scoring is a 0-100 point scale with 100 points considered best. | 6 Months Post-Operative minus Pre-Op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS-PS change from baseline of the ATTUNE knee | The Knee Injury and Osteoarthritis Physical Function Short Form (KOOS-PS) will be used to measure knee function as a means of evaluating the rate of recovery. The (KOOS-PS) is a patient self-administered questionnaire. The questionnaire consists of 7 questions to evaluate function with activities of daily living (ADL) and higher level functioning activities (sport and recreational). Each question has 5 Likert-like response options. Scoring is a 0-100 point scale with 100 points considered best. | Pre-Op (-90 days to day of surgery), 6 weeks (1 - 60 days), 3 months (61 - 137 days), 1 year (304 - 669 days), and 2 years (670 - 913 days) post-operative | 
| Length of Hospital Stay | Collect days of hospitalization related to TKA procedure | Immediate-post-operative: average 1 week | 
| Annual Survivorship | A Kaplan-Meier survival analysis will be used to calculate the survivorship of the ATTUNE implant. | 1 year (304 - 669 days), 2 years (670 - 913 days) post-operative | 
| Type and frequency of Adverse Events (AEs) for all enrolled subjects | All Serious AEs must be reported to the Sponsor per protocol. All device-related and/or procedure-related AEs must be reported to the Sponsor per protocol. | Day 0 - Post-Operative Day 913 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Post-traumatic Arthritis