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The study was designed as prospective, single-arm, multi-center which was intended to broadly capture all patients as the technology is adopted.
The primary objective is to evaluate the implant survivorship of ATTUNE primary, cemented Knee system in Chinese patients using Kaplan Meier Survivorship at 2 yrs. The subject population is male and female subjects who are candidates for primary, total knee arthroplasty between 18 and 80 years of age, inclusive, willing to consent with indications consistent with the Instructions for Use. A total of 120 subjects will be enrolled in this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cemented ATTUNE® Knee System | Device | This product is for total knee arthroplasty. Four implant configurations are permitted: Cruciate Retaining Fixed Bearing (CR FB), Cruciate Retaining Rotating Platform (CR RP), Posterior Stabilizing Fixed Bearing (PS FB) and Posterior Stabilizing Rotating Platform (PS RP) |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survivorship. | To evaluate the implant survivorship of ATTUNE primary, cemented Knee system in Chinese patients using Kaplan Meier Survivorship at 2 yrs. | postoperatively 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee society score (KSS) 2011-surgeon portion at post-operative 2 years compared to pre-op baseline. | Questionnaire. | pre-operative and post-operative 2 years. |
| Knee injury and Osteoarthritis Outcome Score (KOOS) at postoperative 2 years compared to pre-op baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score (KSS) 2011-surgeon portion at post-operative 6 weeks, 6 months and 1 year compared to pre-op baseline. | Questionnaire. | Pre-operative baseline, post-operative 6 weeks, 6 months, and 1 year. |
| Knee injury and Osteoarthritis Outcome Score (KOOS) at postoperative 6 weeks, 6 months, 1 year compared to pre-op baseline. |
Inclusion Criteria:
Exclusion Criteria:
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Male and female Subjects who are candidates for primary, total knee arthroplasty between 18 and 80 years of age, inclusive, willing to consent with indications consistent with the Instructions for Use.
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| Name | Affiliation | Role |
|---|---|---|
| Shudong Zhang | Yantaishan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yantaishan Hospital | Yantai | Shangdong | 264001 | China |
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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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Questionnaire. |
| Pre-operative baseline and post-operative 2 years. |
| Euro Quality of life five Dimensions questionnaire five level (EQ5D-5L) at postoperative 2 years compared to pre-op baseline. | Questionnaire. | Pre-operative and post-operative 2 years. |
| Knee society score (KSS) 2011-patient portion at post-operative 2 years compared to pre-op baseline. | Questionnaire. | Pre-operative baseline and post-operative 2 years. |
| Adverse events and serious adverse events. | Type and frequency of adverse events and serious adverse events. | Up to post-operative 2 years. |
| Implant survivorship. | Kaplan Meier Survivorship at 1 year. | Post-operative 1 year. |
| Health economy. | Patient total charges in hospital. | Post-operative 2 years. |
| Length of hospital stay. | Hospitalization duration for primary surgery. | Through hospitalization for primary surgery, an average of 2 weeks. |
| Destination status. | Home or rehabilitation department/secondary care facility/nursing facility. | At discharge of primary surgery, an average of post-operative 7 days. |
Questionnaire. |
| Pre-operative baseline, post-operative 6 weeks, 6 months and 1 year. |
| Euro Quality of life five Dimensions questionnaire five level (EQ5D-5L) at postoperative 6 weeks, 6 months, 1 year compared to pre-op baseline. | Questionnaire. | Pre-operative baseline, post-operative 6 weeks, 6 months and 1 year. |
| Knee society score (KSS) 2011-patient portion at post-operative 6 weeks, 6 months, 1 year compared to pre-op baseline. | Questionnaire. | Pre-operative baseline, post-operative 6 weeks, 6 months and 1 year. |
| Radiographic evaluation. | Radiographic evaluation at immediate post operation and 6 weeks, 1 year visit. | Immediate post operation, post-operative 6 weeks and 1 year. |