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| Name | Class |
|---|---|
| Johnson & Johnson K.K. Medical Company | INDUSTRY |
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The primary objective is to investigate 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) in the Japanese patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATTUNE Cementless RP TKA | Experimental | Subjects will receive a cementless, rotating platform total knee arthroplasty. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cementless Total Knee Arthroplasty | Device | Patients will undergo a primary total knee replacement using the configuration of the ATTUNE Cementless knee (CR RP) |
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| 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 (670-912 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:
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 .
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirstin Cosgrove | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya orthopedic Clinic | Kitanagoya | Aichi-ken | 481-0011 | Japan | ||
| Nagoya City University Hospital |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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An independent radiographic reviewer will be assessing all radiographs from the study.
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| Minimum 2 years (670-912 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 (670-912 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 (670-912 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 (670-912 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 (670-912 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 (-180 to -1 days before surgery), 6 weeks (1-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery) |
| Survivorship | Kaplan-Meier survival analysis will be used to calculate the survivorship of configuration (CR RP) | Minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 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 (1-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery) |
| Evaluate changes in femoral component and tibial component alignment | 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 (670-912 days after surgery) |
| Radiographically characterize the postoperative ATTUNE patellar component alignment and positioning in Japanese population. | Evaluate the tilt angle and translational position of the patellar component relative to the trochlear groove. | Minimum 1 year (304-669 days after surgery) |
| Nagoya |
| Aichi-ken |
| 467-8601 |
| Japan |
| Kobe University Graduate School of Medicine | Kobe | Hyōgo | 650-0017 | Japan |
| Osaka Rosai Hospital | Sakai | Osaka | 591-8025 | Japan |