A Prospective Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System and iPoly XE Tibial Inserts
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Incidence of Device-related Complications
研究概览
简要总结
This study is designed to evaluate the clinical outcomes of subjects who have recently undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System (KRS) who have also had iPoly XE Tibial Inserts implanted.
详细描述
The study is prospective and single-center. Subjects will be implanted with an iTotal® CR Knee Replacement System in conjunction with an iPoly XE insert. The study will include a minimum of 50 subjects and a maximum of 60 subjects at a single center. The study site will be located in Germany. The study subjects will be followed for 10 years post implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Clinical condition included in the approved Indications For Use for the iTotal® CR
- •Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
- •Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
- •> 18 years of age
排除标准
- •Simultaneous bilateral procedure required
- •Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
- •Poorly controlled diabetes
- •Neuromuscular conditions which prevent patient from participating in study activities
- •Active local or systemic infection
- •Immunocompromised
- •Fibromyalgia or other general body pain related condition
- •Rheumatoid arthritis or other forms of inflammatory joint disease
- •Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified
- •Diagnosed with or receiving treatment for Osteoporosis
- •Other physical disability affecting the hips, spine, or contralateral knee
- •Severe instability due to advanced loss of osteochondral structure
- •Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
- •Compromised PCL or collateral ligament
- •Severe fixed valgus or varus deformity of >15º
- •Extensor lag > 15º
- •Fixed flexion contracture ≥ 15º
- •Unwilling or unable to comply with study requirements
- •Participation in another clinical study which would confound results
- •Allergy to any of the implant materials
结局指标
主要结局
Incidence of Device-related Complications
时间窗: 1 year
Adverse events were categorized as "Device Probably Related", "Device Possibly Related", Device All Related", or "Device Not Related" by the care team for all adverse events (as per the definitions of adverse events on clinicaltrials.gov). Outcome metrics are given in the form of "Events per Patient" which was calculated by dividing the number of adverse in each category by the number of baseline patients.
Incidence of Procedure-Related Complications
时间窗: 1 year
Adverse events were categorized as "Procedure Probably Related", "Procedure Possibly Related", Procedure All Related", or "Procedure Not Related" by the care team for all adverse events (as per the definitions of adverse events on clinicaltrials.gov). Outcome metrics are given in the form of "Events per Patient" which was calculated by dividing the number of adverse in each category by the number of baseline patients.
次要结局
未报告次要终点