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The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).
The secondary objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATTUNE Cementless RP TKA | Experimental | Subjects will receive a cementless, rotating platform total knee arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cementless Total Knee Arthroplasty | Device | Patients will undergo a primary total knee replacement using one of the two configurations of the ATTUNE Cementless knee (CR RP or PS RP) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL) | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. 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. | Minimum 2 years (670-1033 days after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP) | The Pre Surgical and/or 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. |
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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 |
|---|---|---|---|---|---|---|
| Colorado Joint Replacement | Denver | Colorado | 80210 | United States | ||
| Florida Research Associates |
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An independent radiographic reviewer will be assessing all radiographs from the study.
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| Minimum 2 years (670-1033 days after surgery) |
| Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS) | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. 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. | Minimum 2 years (670-1033 days after surgery) |
| Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011 | The Knee Society Score is a self-administered questionnaire. The subject completes questions regarding: Symptoms (3 questions), Patient Satisfaction (5 questions), Patient Expectations (3 questions), Functional Activities (5 questions), Standard Activities (6 questions), Advanced Activities (5 questions), and Discretionary Knee Activities ( 4 questions). The surgeon completes questions regarding objective knee indicators. Likert responses are used, typically with five response options. | Minimum 2 years (670-1033 days after surgery) |
| Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L) | EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject. | Minimum 2 years (670-1033 days after surgery) |
| Modified VAS Pain Score: Pain and Satisfaction | VAS Pain Score is a standardized instrument for use as a measure of pain and satisfaction that is designed for completion by the subject. This modified version has scores that are discrete numbers rather than a continual scale | Minimum 2 years (670-1033 days after surgery) |
| Type and Frequency of Adverse Events (AEs) for all enrolled subjects | All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor. | Pre-op (-90 to -1 days before surgery), 6 weeks (1-90 days after surgery), 6 months (91-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-1033 days after surgery), minimum 5 years (1764-2190 days after surgery) |
| Survivorship | Kaplan-Meier survival analysis will be used to calculate the survivorship of all 2 configurations (CR RP, PS RP) | Minimum 2 years (670-1033 days after surgery) |
| Survivorship | Kaplan-Meier survival analysis will be used to calculate the survivorship of all 2 configurations (CR RP, PS RP) | Minimum 5 years (1764-2190 days after surgery) |
| Implant fixation: Radiographic assessment of bone-implant interface performance | Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane. | 6 weeks (1-90 days after surgery) |
| Implant fixation: Radiographic assessment of bone-implant interface performance | Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane. | 6 months (91-303 days after surgery) |
| Implant fixation: Radiographic assessment of bone-implant interface performance | Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane. | Minimum 1 year (304-669 days after surgery). |
| Implant fixation: Radiographic assessment of bone-implant interface performance | Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane. | Minimum 2 years (670-1033 days after surgery) |
| Evaluate changes in femoral component and tibial component alignment | Radiographs will be reviewed by an independent radiographic reviewer (IRR) in order to minimize bias of radiographic outcomes. Data from the IRR radiographic evaluations will be used to evaluate femoral and tibial component alignment over time. | Minimum 2 years (670-1033 days after surgery) |
| DeLand |
| Florida |
| 32720 |
| United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| New London Hospital | New London | New Hampshire | 03257 | United States |
| Rothman Institute | Egg Harbor | New Jersey | 08234 | United States |
| SUNY downstate Medical Center | Brooklyn | New York | 11203 | United States |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Associated Orthopaedics of Kingsport | Kingsport | Tennessee | 37660 | United States |
| Texas Tech University Heath Science Center | Lubbock | Texas | 49416 | United States |
| Hampton Roads Orthopaedics and Sports Medicine | Newport News | Virginia | 23606 | United States |
| Krankenhaus der Barmherzigen Schwestern Ried im Innkreis | Ried im Innkreis | Upper Austria | 4910 | Austria |
| Foothills Medical Centre, University of Calgary | Calgary | Alberta | T2N 2T9 | Canada |
| CHU de la Cavale Blanche | Brest | Cedex | 29285 | France |
| Sevice de Chirurgie Orthoedique et Traumatologique | Salouël | 80480 | France |
| Klinikum Garmisch-Partenkirchen GmbH | Garmisch-Partenkirchen | 82467 | Germany |
| South Infirmary Victoria University Hospital | Cork | T12 X23H | Ireland |
| Elkerliek Ziekenhuis | Helmond | North Brabant | 5707 HA | Netherlands |
| University of Otago | Christchurch | 8083 | New Zealand |
| Wrightington Hospital | Wigan | Lancashire | WN6 9EP | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG5 1PB | United Kingdom |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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