A Prospective, Multi-Center, Post-Market Clinical Study to Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System in Total Knee Arthroplasty Procedures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 6
- 主要终点
- Quality of Life: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) at 12 months
研究概览
简要总结
To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.
详细描述
This is a post-market, prospective, multicenter, open-label study evaluating the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System at approximately 4 centers across the United States. Ninety (90) patients eligible for a robotic-assisted TKA procedure with the CORI™ Surgical System will be followed for approximately 12 months.
The CORI™ KNEE TENSIONER is an accessory to REAL INTELLIGENCE™ CORI™ Surgical System. The TENSIONER may assist the surgeon in providing consistent varus and valgus stress during gap assessment before making any bony resections. The TENSIONER communicates directly with CORI software, providing automated data collection.
The primary objective is to evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System by assessing patient satisfaction with the EQ-5D-5L VAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject agrees to consent to the study by signing the Independent Review Board (IRB) approved ICF.
- •Subject is eighteen (18) years old or older.
- •Subject is willing and able to attend all study follow-up visits for up to one (1) year postoperatively (as defined in the study protocol and ICF).
- •Subject can read, understand, and communicate responses to Patient Reported Outcome Measures (PROMs).
- •Subject is suitable for the CORI™ Surgical System.
- •Subject requires a cemented TKA as a primary indication due to any of the following conditions:
- •Degenerative joint disease, including osteoarthritis
- •Rheumatoid arthritis.
- •Avascular necrosis.
- •Requires correction of functional deformity
- •Requires treatment of fractures that were unmanageable using other techniques.
排除标准
- •Contraindications or hypersensitivity to the use of the CORI™ Surgical System per the IFU.
- •Participation in the treatment period of another clinical trial within thirty (30) days of the Pre-Operative Visit, or during the study.
- •Women who are pregnant, nursing, or of child-bearing potential who are not utilizing birth control measures.
- •Subjects who are non-English speaking.
- •Any subject that meets the definition of a Vulnerable Subject per ISO
- •Subjects who have participated previously in this clinical trial
- •Subjects with a history of poor compliance with medical treatment.
- •Subject needs a CORI™ Surgical System TKA on the index joint as a revision for a previously failed surgery, or need for complex implants, or any other implant than a standard TKA (e.g., stems, augments, or custom-made devices).
- •Subject has been diagnosed with post-traumatic arthritis
- •Subject needs a bilateral TKA.
- •Subject has active infection or sepsis (treated or untreated)
- •Subject is morbidly obese with a body mass index (BMI) greater than
- •Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study. This includes:
- •Advanced osteoarthritis
- •Joint disease
- •Paget's or Charcot's disease
- •Vascular insufficiency
- •Muscular atrophy
- •Uncontrolled diabetes
- •Moderate to severe renal insufficiency
- •Neuromuscular disease
- •Mental illness or mental retardation
- •Drug or alcohol abuse
结局指标
主要结局
Quality of Life: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) at 12 months
时间窗: 12 months
The VAS records the subject's self-rated health on a vertical visual analogue scale. The endpoints on the scale are labelled "The best health you can imagine" and "The worst health you can imagine". Participants indicate a numerical value from 1-100 where 0 is the worst imaginable health state and 100 is the best imaginable health state. The VAS can be used as a quantitative measure of health outcome as judged by the individual respondents.
EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
时间窗: Baseline, 6 weeks, 6 months, 12 months
Change from baseline to 6 weeks, 6 months, and 12 months in EQ-5D-5L VAS score. The EQ-5D-5L is composed of the EQ-5D-5L descriptive system (i.e., Index score) and the EQ Visual Analogue scale (i.e., VAS score). The EQ-5D-5L VAS score records the participant's self-rated health on a vertical visual analogue scale. The endpoints on the scale are labelled "The best health you can imagine" and "The worst health you can imagine". Participants indicate a numerical value from 0 to 100 where 0 is the worst imaginable health state and 100 is the best imaginable health state (i.e., a higher score was a better outcome).
次要结局
- Quality of Life (EQ-5D-5L Index score)(Pre-operative, 6 weeks, 6 months, and 12 months)
- 2011 Knee Society Score (KSS)(Pre-operative, 6 weeks, 6 months, and 12 months)
- Quality of Life: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) pre-operative, 6 weeks, and 6 months(pre-operative, 6 weeks, and 6 months)
- EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months(Baseline, 6 weeks, 6 months, 12 months)
- 2011 Knee Society Score (KSS): Objective Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months(Baseline, 6 weeks, 6 months, 12 months)
- 2011 Knee Society Score (KSS): Function Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months(Baseline, 6 weeks, 6 months, 12 months)
- 2011 Knee Society Score (KSS): Satisfaction Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months(Baseline, 6 weeks, 6 months, 12 months)
- 2011 Knee Society Score (KSS): Expectation Score at Baseline, 6 Weeks, 6 Months, and 12 Months(Baseline, 6 weeks, 6 months, 12 months)