By InvitationNot Applicable

Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty

United States713 participantsStarted 2017-11-09

Plain-language summary

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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patient must be a candidate for a primary or revision total knee arthroplasty
✓. Patient is able and willing to sign the informed consent and follow study procedures
✓. Patient's joint must be anatomically and functionally suited to receive the selected implant and accommodate use of the robotic assistance

Exclusion criteria

✕. Patient has a BMI \>45.
✕. Significant neurological or musculoskeletal disorders or disease that may interfere with total knee arthroplasty survival, adversely affect gait or weight bearing, (i.e. Paget's disease, Charcot's disease, muscular dystrophy, multiple sclerosis).
✕. The presence of highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, HIV, etc.).
✕. Presence of known active metastatic or neoplastic disease.
✕. Cancer patients unless they have received curative treatment and have no evidence of recurrence for 5 years.
✕. Patient has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease).
✕. Patient has an active infection or joint sepsis.
✕. Patient has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Multiple Sclerosis, and Charcot joints).

What they're measuring

Survivorship

Timeframe: 10 Years

Trial details

NCT IDNCT06203756

SponsorCorin

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-01-01

View on ClinicalTrials.gov More Arthroplasties, Knee Replacement trials