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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATTUNE Revision Knee System | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATTUNE Revision Knee System in Revision Total Knee Arthroplasty | Device | 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. |
| 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 |
| 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) |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sukhjeet Kaur | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic Torrey Pines | San Diego | California | 92037 | United States | ||
| Colorado Joint Replacement |
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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) |
| Denver |
| Colorado |
| 80210 |
| United States |
| Orthopaedic Center of the Rockies | Fort Collins | Colorado | 80525 | United States |
| Orthopedic Partners | Niantic | Connecticut | 06357 | United States |
| Florida Orthopedic Associates | DeLand | Florida | 32720 | United States |
| Arthroplasty Foundation | Louisville | Kentucky | 40215 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Mery Hospital | Ozark | Missouri | 65721 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Rothman Institute | Egg Harbor | New Jersey | 08234 | United States |
| UNC Orthopaedics | Chapel Hill | North Carolina | 27514 | United States |
| OrthoCarolina Hip and Knee Center | Charlotte | North Carolina | 28207 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Southern Joint Replacement Institute | Nashville | Tennessee | 37203 | United States |
| Texas Institute for Hip & Knee Surgery | Austin | Texas | 78751 | United States |
| Fondren Orthopedic Group | Houston | Texas | 77030 | United States |
| The Gold Coast Centre for Bone and Joint Surgery | Gold Coast | Australia |
| St. John of God Murdoch Hospital | Perth | Australia |
| Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H. | Linz | Austria |
| MoRe Foundation | Antwerp | Belgium |
| London Health Sciences Centre University Hospital | London | Ontario | Canada |
| Concordia Joint Replacement | Winnipeg | Canada |
| CHRU La Cavale Blanche | Brest | France |
| Centre Hospitalier Universitaire de Rennes | Rennes | France |
| Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche | Munich | Germany |
| Asklepios Orthopädische Klinik Lindenlohe | Schwandorf in Bayern | Germany |
| South Infirmary Public Hospital | Cork | Ireland |
| CLINICHE GAVAZZENI SPA aka Humanitas Castelli | Bergamo | Italy |
| University Hospital Maastricht | Maastricht | Netherlands |
| Wellington Hospital | Wellington | New Zealand |
| Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Department of Orthopaedic Surgery and Traumatology | Basel | Switzerland |
| Hampshire Hospitals NHS Foundation Trust | Basingstoke | United Kingdom |
| Victoria Hospital NHS Fife | Kirkcaldy | United Kingdom |
| Chapel Allerton Orthopaedic Centre | Leeds | United Kingdom |
| James Cook University Hospital | North Yorks | United Kingdom |
| The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust | Oswestry | United Kingdom |
| Nuffield Orthopaedic Centre | Oxford | United Kingdom |
| Wrightington Hospital | Wigan | United Kingdom |