Improved Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Corin
- 入组人数
- 713
- 试验地点
- 12
- 主要终点
- Survivorship
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient has a BMI >
- •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.
结局指标
主要结局
Survivorship
时间窗: 10 Years
Frequency of device and implant related adverse events and revision surgery to be recorded.
次要结局
- Change in KOOS from baseline to 10 years after surgery(from enrolment to 10 years)
- Change in UCLA from baseline to 10 years after surgery(from enrolment to 10 years)
- Change in Promis-10 from baseline to 10 years after surgery(from enrolment to 10 years)