Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty

Официальное название

Improved Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC
  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
• Устройство Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS
  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
• Устройство Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision
  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

Первичные конечные точки

• Survivorship [Срок оценки: 10 Years]

Вторичные конечные точки (3)

• Change in KOOS from baseline to 10 years after surgery [Срок оценки: from enrolment to 10 years]
• Change in UCLA from baseline to 10 years after surgery [Срок оценки: from enrolment to 10 years]
• Change in Promis-10 from baseline to 10 years after surgery [Срок оценки: from enrolment to 10 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).
• Patients with allergies or suspected sensitivity to any patient-contacting component of the implant to be used in the study Has known sensitivity to implants or the materials in the device including but not limited to: Ti, Al, V, Co, Cr, Mo, Ni and Si3N4.).
• Patients who are currently on medical leave from their employment due to Worker's Compensation.
• Patients who are at high risk for poor healing or confounding outcomes or at excessive risk for surgery (e.g., clinically significant/being actively treated for renal, hepatic, cardiac, hematologic, or neurologic disease or poorly controlled diabetes (HbA1c > 8 mg/dL) or previous history of joint infection).
• Patients who are known drug or alcohol abusers or with psychological disorders as defined by DSM V that could affect follow-up care or treatment outcomes.
• Patients who are currently involved in another clinical study with an investigational device.
• Patients with current litigation pending related to medical treatment of any sort.
• Patients, who, in the opinion of the investigator, will not be able to complete the study per the protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Flagstaff Bone and Joint — Flagstaff
• Orthopaedics New England — Middlebury
• DeClaire LaMacchia Orthopaedic Institute — Rochester
• Nyu Langone-Long Island — Garden City
• Oklahoma Sports and Orthopedics Institute — Oklahoma City
• Gundersen Health System — La Crosse

Идентификаторы

NCT: NCT06203756 · CSP-2017-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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