ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

Study Overview
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Brief Summary
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Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in complex primary total knee arthroplasty.

Detailed Description
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Within primary TKA, there are factors that lead to more complex procedures that include patients with high BMIs, advanced preoperative deformities and ligamentous laxity. Such cases may require the surgeon to treat using ancillary components, such as stems and/or augments and/or additional constraint. This post-market study will evaluate the short/medium term clinical performance and medium term survivorship of the ATTUNE Revision system system, which includes instrumentation, in complex primary TKA. The study is designed as a worldwide non-comparative, multi-center study with each site initially having a cohort of approximately 20 Subjects to recruit. The study will enroll approximately 200 fixed bearing and approximately 200 rotating platform configurations. The 2-year KOOS-ADL (activities of daily living) was selected as the primary endpoint because it will evaluate the post-operative period during which outcomes typically plateau and will therefore provide a good indication of longer term outcomes Male and female Subjects, age 22-80 years, inclusive, who require a primary knee arthroplasty in a joint that, due to deformity, instability, bone loss etc., necessitates the use of implants found within the ATTUNE Revision knee system and are suitable candidates for TKA using the ATTUNE® Revision system are eligible for enrollment in this study.

Official Title
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Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee Arthroplasty

Conditions
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Primary Knee Arthroplasty

Intervention / Treatment
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* Device: ATTUNE Revision Knee System in Total Knee Arthroplasty


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 at the time of consent, inclusive. The decision to have knee replacement with the study device is regardless of the research. The devices are to be used according to the approved indications. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the 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 read, and comprehend the Informed Consent Document as well as complete the required PROMs in either English or one of the available translations. Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.) Exclusion Criteria: The Subject is a woman who is pregnant or lactating. Contralateral knee has already been enrolled in this study. If the Investigator plans to treat a potential study subject with either simultaneous (two (2) knees in one (1) surgical setting) or staged bilateral TKA, then this subject may be enrolled; however, only the first knee may be enrolled into this study. Subject had a contralateral amputation. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) or primary TKA in affected knee. Subject is currently diagnosed with 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 (3) 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 his/her 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 activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease). Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator. Subject has been diagnosed with an inflammatory arthritis (including uncontrolled gout, rheumatoid, psoriatic etc.). -

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ATTUNE Revision knee system<br>The ATTUNE Revision knees system is complementary to the ATTUNE primary knee portfolio and includes both rotating platform (RP) and fixed bearing (FB) configurations. The system includes a full compliment of implants designed to address the challenges faced in complex primary knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets | Device: ATTUNE Revision Knee System in Total Knee Arthroplasty<br>* Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their anatomy is such that the use of revision components are required to perform primary total knee arthroplasty<br>* Other names: complex primary knee arthroplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS ADL | Evaluate change from preoperative baseline to the 2 yr timepoint in patient reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA FB and RP configurations. | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Living (KOOS-ADL) | Evaluate change from preoperative baseline to the 5 yr timepoint in functional outcomes as measured using KOOS patient reported outcomes measure (PROM). | Baseline, 5 Year | 
| Patient's Knee Implant Performance (PKIP) | Evaluate change from preoperative baseline to 5 yr timepoint in functional outcomes, satisfaction and quality of life assessments, as measured using the PKIP patient reported outcome measure | Baseline, 5 Year | 
| American Knee Society Score | valuate change from preoperative baseline to 5 yr timepoint in functional outcomes assessments, patient satisfaction and expectations and clinical evaluations as measured using the AKS measure | Baseline, 5 Year | 
| EQ-5D-5L | Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes and quality of life assessments, as measured using the EQ-5D-5L patient reported outcome measure | Baseline, 5 year | 
| VAS Pain Score | Evaluate change from preoperative baseline to 5 yr timepoint in patient reported pain severity as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale). | Baseline, 5 year | 
| American Knee Society Score | Evaluate change from preoperative baseline to the 5 yr timepoint in patient reported satisfaction from the AKS 2011 over time as measured using a Likert scale. | Baseline, 5 year | 
| American Knee Society Score (surgeon evaluation) | Estimate the change from preoperative baseline to the 5 yr timepoint in clinical outcomes using the 2011 AKS (surgeon evaluation) | Baseline, 5 year | 
| Adverse Events | Evaluate type and frequency of Adverse Events | Intraoperative, 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr. | 
| Readmissions | Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic). | 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr. | 
| Survivorship | Evaluate survivorship of the ATTUNE® Revision TKA system for the PS FB and PS RP configurations and the combined PS FB and PS RP configurations using Kaplan-Meier survival analysis at 1, 2, 3, 4 and 5 years. | 1, 2, 3, 4 and 5 years | 
| Frequency of radiolucent line occurrence | Evaluate ATTUNE® Revision TKA fixation through zonal radiographic analysis of the bone-implant interface at 1, 2 and 5 years after surgery compared to the first postoperative radiographs. | 1, 2 and 5 years | 
| Anatomic Tibiofemoral Alignment | Evaluate any changes in anatomic tibiofemoral alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs. | 1, 2 and 5 years | 
| Femoral component alignment | Evaluate any changes in femoral component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs. | 1, 2 and 5 years | 
| Tibial component alignment | Evaluate any changes in tibial component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs. | 1, 2 and 5 years | 
| Restoration of joint line | Radiographically evaluate the restoration of joint line using the first postoperative radiographs according to the methodology of Figgie. | First post-operative radiograph (1 day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complex primary, deformity, ligamentous laxity