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This is a multicenter, prospective and randomized controlled pre-market clinical Trial. Study subjects will be randomized into one of two operative groups: 1) TKA assisted with ROSA® Knee System; 2) TKA with conventional surgical instrumentation.
The objective of this clinical trial is to measure the effectiveness and safety of the ROSA® Knee System in assisting surgeons with bone resections and implant positioning optimization through early clinical and radiographic outcomes compared with conventional surgical instrumentation in total knee arthroplasty (TKA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKA assisted with ROSA® Knee System | Experimental | TKA assisted with ROSA® Knee System |
|
| TKA with conventional surgical instrumentation | Active Comparator | TKA with conventional surgical instrumentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROSA assisted TKA | Procedure | Robotic assisted total knee arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical axis alignment | Deviation from neutral mechanical axis alignment based on full-leg weight-bearing X-ray at 6 weeks (±2 week) postoperatively. | 6 weeks (±2 week) postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Coronal Lower Limb Alignment | Coronal Lower Limb Alignment based on full-leg weight-bearing X-ray at 6 weeks (±2 week) postoperatively. | 6 weeks (±2 week) postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yonggang Zhou | PLA Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PLA Hospital | Beijing | Beijing Municipality | 100048 | China |
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