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This is a post-market multicentre study that has been implemented to confirm safety and performance of cemented CR/UC and PS Apex Knee implants in primary or revision Robotic Assisted Total Knee Arthroplasty up to 10-year follow up.
This study has been implemented to confirm safety and performance of cemented CR/UC and PS Apex Knee implants in primary or revision RA-TKA up to 10-year follow up.
Prospective data will be collected for this Post Market Clinical Follow up (PMCF) study and the data will be fed into the Post-Market Surveillance (PMS) and Clinical Evaluation processes of the devices under assessment on annual basis and support presentations at orthopaedic congresses and/or peer-reviewed publication(s).
Participants will be selected for recruitment into the study from the general population of participants requiring a primary or revision knee-arthroplasty and considered suitable to receive the Apex Knee System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revision Total Knee Arthroplasty | Other | Sensor-assisted robotic surgery cohort with a tibia first workflow. Revision Total Knee Arthroplasty components. |
|
| Primary Total Knee Arthroplasty | Other | Sensor-assisted robotic surgery cohort with a tibia first workflow. Primary Total Knee Arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC | Device | Robotic-assisted total knee arthroplasty in femur and tibial first workflows using the BalanceBot to characterize soft tissue balance, and the Apex UltraCongruent (UC) knee implant type |
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship | Frequency of device and implant related adverse events and revision surgery to be recorded. | 10 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in KOOS from baseline to 10 years after surgery | Evaluate impact of participants knee surgery, comparing post-operative Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores and participants opinion about their knee KOOS ranges from 0 - 100, in which 100 is best. | from enrolment to 10 years |
| Change in UCLA from baseline to 10 years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan A Koenig, MD | NYU LANGONE-LONG ISLAND | Principal Investigator |
| Jeffrey H DeClaire, MD | DeClaire LaMacchia Orthopaedic Institute | Principal Investigator |
| Amber Randall, MD | Granite Orthopaedics | Principal Investigator |
| Corey Ponder, MD | Oklahoma Sports and Orthopedics Institute | Principal Investigator |
| John Keggi, MD | Orthopaedics New England | Principal Investigator |
| Jeffrey Lawrence, MD | Gundersen Lutheran Medical Foundation, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flagstaff Bone and Joint | Flagstaff | Arizona | 86001 | United States | ||
| Orthopaedics New England |
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|
| Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS | Device | Robotic-assisted total knee arthroplasty with a tibial first workflow using the BalanceBot to characterize soft tissue balance, and the Apex PosteriorStabilized (PS) knee implant type |
|
| Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision | Device | Robotic-assisted total knee arthroplasty with a tibial first workflow using the BalanceBot to characterize soft tissue balance, and the Apex Revision knee implant type |
|
Evaluate impact of participants knee surgery, comparing post-operative Knee Injury and University of California Los Angeles (UCLA) activity Scale and measured the participants usual level of activity UCLA ranges from 0 - 10, in which the higher the score the greater the activity |
| from enrolment to 10 years |
| Change in Promis-10 from baseline to 10 years after surgery | Evaluate impact of participants knee surgery, comparing post-operative Knee Injury and Patient-Reported Outcomes Measurement Information System (PROMIS) and measures the participants physical, mental, and social health. PROMIS-10 ranges from 1 - 67, in which 67 is best. | from enrolment to 10 years |
| Middlebury |
| Connecticut |
| 06762 |
| United States |
| DeClaire LaMacchia Orthopaedic Institute | Rochester | Michigan | 48307 | United States |
| Nyu Langone-Long Island | Garden City | New York | 11530 | United States |
| Oklahoma Sports and Orthopedics Institute | Oklahoma City | Oklahoma | 73114 | United States |
| Gundersen Health System | La Crosse | Wisconsin | 54601 | United States |