NCT01820650终止不适用
A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
Restor3D9 个研究点 分布在 1 个国家目标入组 359 人开始时间: 2013年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 359
- 试验地点
- 9
- 主要终点
- 2011 Knee Society Score
研究概览
简要总结
This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.
详细描述
If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard total knee for all time points where questionnaires are required by the protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •BMI > 40
- •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 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 > 15 º
- •Fixed flexion contracture ≥ 15 º
- •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
2011 Knee Society Score
时间窗: 1 Year
次要结局
未报告次要终点
研究者
研究点 (9)
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