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The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.
The objectives of the study are to document that ROSA Knee System can provide intraoperative planning adjustment based on feedbacks obtained by laxity as well as gaps to locally preferred surgeon's operative philosophy. This will also provide accuracy, intraoperative soft tissue release as well as patient outcome on locally preferred surgical technique.
The primary endpoint is defined as the mean absolute difference between X-Atlas image-based pre-op plan & intra-op final plan.
The secondary endpoints include Kinematic Analysis, EuroQol 5 dimensions (EQ-5D), Rehabilitation record, Knee Society Score (KSS) 2011, image assessment and Safety up to 2 years postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKA with ROSA Knee | Total Knee Arthroplasty (TKA) is conducted using with robotic surgical assistant (ROSA) system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Replacement (TKR) | Device | Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean absolute difference between X-Atlas image based pre-op plan & intra-op final plan | The mean absolute difference between X-Atlas image-based pre-op plan and intra-op final plan in order to demonstrate the ability of the system to allow for intra-operative adjustments | Immediate post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Pain, range of knee motion and functional performance | The Knee Society Score 2011, and Physical Exam to evaluate pain, range of knee motion and functional performance | Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months |
| QOL |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will comprise of males and females who require primary total knee arthroplasty and satisfy the inclusion/exclusion criteria outlined in this section of the protocol. In order to avoid potential selection bias, each Investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary total knee arthroplasty using the commercially available Zimmer Biomet total knee systems. Eligible candidates who express interest in study participation will be offered Informed Consent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noriko Sugawara | Contact | +81-3-6402-6600 | noriko.sugawara@zimmerbiomet.com |
| Name | Affiliation | Role |
|---|---|---|
| Yasuharu Nakashima | Kyushu University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyushu University Hospital | Recruiting | Fukuoka | Fukuoka | 812-8582 | Japan |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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Subject quality-of-life will be measured by the EuroQol 5 dimensions 5-level (EQ-5D-5L) |
| Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months |
| Rehabilitation record | Recovery of patient will be assessed by prescribed Rehabilitation record and compliance | Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months |
| Kinematic analysis | Kinematic analysis will be conducted to visualize postoperative knee motion | Postoperative 12 months or 24 months |
| Image review (CT/Radiograph) | Image review (CT/Radiograph) to assess the accuracy of the implant position, radiolucency, osteolysis, atrophy, hypertrophy, component migration, device fracture, heterotopic ossification, etc. | Preoperative, Discharge, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |