NCT01564641终止不适用
A Prospective, Multicenter Study of the ConforMIS iDuo(R) G2 Bicompartmental Knee Repair System
Restor3D3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年5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
- 150
- 试验地点
- 3
- 主要终点
- Pain and function
研究概览
简要总结
To evaluate the ConforMIS iDuo G2 implant
详细描述
This is a prospective, multicenter study. The investigators will be evaluating the ConforMIS iDuo G2 implant.
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 iDuo® G2
- •Bicompartmental osteoarthritis defined as Medial and patellofemoral osteoarthritis, or Lateral and patellofemoral arthritis as confirmed by the investigator's assessment of disease status at screening visit. Disease status is assessed by Clinical and Radiographic assessment. In addition, CT arthrogram assessment may be utilized for diagnosis.
- •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
- •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 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
- •Compromised ACL, PCL or collateral ligament
- •Severe fixed valgus or varus deformity of >15º
- •Extensor lag > 15 º
- •Fixed flexion contracture ≥ 10 º
- •Prior history of failed implant surgery of the joint to be treated, including high tibial osteotomy (HTO)
- •Unwilling or unable to comply with study requirements
- •Participation in another clinical study which would confound results
- •If during intra-op, it is noted that the patient has tri-compartmental disease, then the patient is considered a screen fail
结局指标
主要结局
Pain and function
时间窗: 3 months
By using questionnaires, we will look at pain and function scores at this time point
次要结局
- Revision rates(Patient will be observed for 10 years post implant)
- Radiographic implant position(X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups)
- Radiographic loosening, radiolucencies(X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups)
- Length of procedure(Day of surgery)
- Blood loss during surgery(Day of surgery)
- Pain and function at follow up time points(1, 2, 5 and 10 years post implant)
- Length of hospital stay(Patient will be followed from admission to discharge with an average of about 5 days)
- Intraoperative blood replacement volume(Day of surgery)
- Incidence of major procedure related and device related complications(Patient will be observed for 10 years post implant)
- Post operative limb alignment(X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups)
研究者
研究点 (3)
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