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This pilot study seeks to evaluate the initial safety and usability of new features for the ROSA® Knee System, v1.5 and plan design modifications as needed.
The primary objectives will be assessed by measuring:
This study will involve single-arm, monocentric, cross-sectional observations conducted on the day of surgery. All assessments will take place during the pre-operative, intra-operative, and immediate postop periods on the day of surgery, with no additional follow-up beyond the procedure as robotic-assisted surgery using the current version of the robot is part of routine practice.
The safety of the system is the primary endpoint. This will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary endpoint is defined by the usability of Zimmer Biomet ROSA® Knee System, v1.5. It will be assessed by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Zimmer Biomet ROSA® Knee System, v1.5 | Experimental | This study will include a single-arm of patients who qualify for robotic-assisted (RA) total knee arthroplasty (TKA) with the ROSA® Knee System and are planned to receive commercially available and compatible implants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Arthroplasty | Device | Robotic-assisted primary total knee arthroplasty, evaluating updated features for the Zimmer Biomet ROSA® Knee System, v1.5. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Procedure-Emergent Adverse Events, to assess the Safety of the ROSA® Knee System v1.5 System | The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. This will occur through the reporting of adverse events that outline the details and relationship to:
| Intra-operative observations, with immediate post-operative documentation and reporting period. |
| Measure | Description | Time Frame |
|---|---|---|
| Verification and Usability of the OptimiZe Planning and Activ Track Investigational Features of the ROSA® Knee System v1.5 System | Robotic log files will be evaluated to assess the following: a) The delta between the OptimiZe proposed plan and the final plan approved by the surgeon, planned and final laxities, planned and final resections thus allowing for conclusions to be drawn from objective datapoints on the verification of the OptimiZe planning feature, and its validation to execute the proposed plan. Additionally, surgeon satisfaction with the features will be evaluated with the following questionnaire (Case Report Form), to determine usability:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kensington Private Hospital | Kensington | Whangarei | 0112 | New Zealand |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 7, 2026 | |
| Reset | Jun 2, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 7, 2026 | Jun 2, 2026 |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| 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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Single-arm, monocentric, cross-sectional, pilot study
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| Intra-operative evaluation, with immediate post-operative assessment and documentation. Data and statistical analysis will take place after the recruitment period has concluded. |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |