NCT03738462终止不适用
A Prospective, Multicenter Study to Evaluate the Conformis Hip System
Restor3D6 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2018年11月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 49
- 试验地点
- 6
- 主要终点
- Harris Hip Score
研究概览
简要总结
This is a prospective multicenter study. Subjects will be implanted with a Conformis Hip System. If the surgeon intraoperatively decides to use the Cordera femoral stem, these patients will also be enrolled in the study and tracked as a subset of the Conformis Hip System patient population.The study sites will be located in the United States. The study subjects will be followed for 10 years post implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 Conformis Hip System and the Cordera Hip System
- •Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a THR procedure
- •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
- •Poorly controlled diabetes (defined as HbA1c>7 or Investigator discretion)
- •Crowe classification of hip dysplasia, grades 2, 3, or 4
- •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
- •Other lower extremity surgery planned within 1 year of consent to the affected limb Contralateral THR surgery within 3 months pre or post index surgery
- •Neuromuscular conditions which prevent patient from participating in study activities
- •Active local or systemic infection which precludes THR procedure
- •Immunocompromised in the opinion of the Investigator
- •Medically diagnosed fibromyalgia or similar conditions that might impact the patient's ability to differentiate source of pain
- •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 that is likely to confound results in the opinion of the Investigator
- •Physical disability affecting the lumbar spine that is likely to confound results in the opinion of the Investigator
- •Charcot or Paget's disease
- •Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
- •Participation in another clinical study which would confound results
- •Allergy to any of the implant materials
结局指标
主要结局
Harris Hip Score
时间窗: 2 Years
Score 0-100 (successful result = post operative increase in Harris Hip Score of \> 20 points + radiographically stable implant + no additional femoral reconstruction; \< 70 = poor, 70-79 - fair, 80-89 = good, and 90-100 = excellent)
次要结局
- Length of procedure(Peri-operative)
- Length of hospital stay(Peri-operative)
- Incidence of major procedure-related and device-related complications including infection rate(10 Years)
- The Hip Injury and Osteoarthritis Outcome Score (HOOS)(10 Years)
- Post-operative leg length and implant placement in comparison to preoperative condition(Peri-operative)
- Utilization of fluoroscopy during implantation (number of times utilized; amount of times utilized)(Peri-operative)
- Revision rates post-implantation(10 Years)
- Blood management (transfusions)(Peri-operative)
研究者
研究点 (6)
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