ATTUNE Revision System in the Revision 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 revision total knee arthroplasty.

Detailed Description
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The study is designed as a non-comparative, worldwide, multi-center study with up to 30 sites that will intend to implant a total of 400 Subjects (200 PS RP and 200 PS FB) with the study devices. The follow-up period of 5 years was selected to cover both the early post-operative period as well as the medium term period which is a good indicator of longer term survivorship. The primary endpoint of survivorship at 5 years was selected to capture the time period during which the majority of revision failures occur while providing a good indication of long term survivorship. The secondary outcomes include commonly used measures of clinical performance that will allow for comparison with published literature. Additionally, patient reported outcomes, AORI bone defect classification , satisfaction and pain scores will be collected and analyzed. Male and female Subjects, age 22-80 years, inclusive, with a failed primary knee arthroplasty, including unicompartmental or failed previous revision TKA, who are suitable candidates for revision TKA using the ATTUNE® Revision system are eligible for enrollment in this study. The use of the ATTUNE Revision system includes both partial and complete revision surgical procedures, including implantation of revision components as the second stage within a two-stage treatment for infection.

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

Conditions
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Revision Total Knee Arthroplasty

Intervention / Treatment
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* Device: ATTUNE Revision Knee System in Revision 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. Subject presents with a primary knee arthroplasty (primary TKA, unicompartmental) or prior revision TKA that requires a revision procedure of implanted tibial and/or femoral components. The decision to perform a knee revision with the study device is regardless of the research. 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 The devices are to be used according to the approved indications.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. 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. Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive RTKA. 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. Uncontrolled gout

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 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 revision knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets | Device: ATTUNE Revision Knee System in Revision Total Knee Arthroplasty<br>* Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their existing implants need to be removed and replaced.<br>* Other names: previous unsuccessful knee replacement, knee revision;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship | To evaluate the 5 year survivorship using Kaplan-Meier survival analysis, with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS FB and PS RP configurations. | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Knee Implant Performance (PKIP) | Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes, satisfaction and quality of life assessments, as measured using the PKIP patient reported outcome measure (overalll and subscores) | Baseline, 2 and 5 yr timepoints | 
| Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS) | Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, as measured using the KOOS-PS patient reported outcome measures | Baseline, 2 year and 5 Year | 
| American Knee Society Score | Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, patient satisfaction and expectations and clinical evaluations as measured using the AKS measure | Baseline, 2 year, 5 year | 
| EQ-5D-5L | Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, as measured using the EQ-5D-5L patient reported outcome measures | Baseline, 2 year and 5 year | 
| VAS Pain Score | Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported pain severity as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale). | Baseline, 2 year and 5 year | 
| Patient Satisfaction | Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported satisfaction as measured using a Likert scale. | Baseline, 2 year and 5 year | 
| Adverse Events | Evaluate type and frequency of Adverse Events | Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs. | 
| Readmissions | Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic). | 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs | 
| 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, and 4 years. | 1, 2, 3 and 4 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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Revision knee surgery, implant replacement