NCT00833430终止不适用
Hedrocel Avascular Necrosis (AVN) Intervention Implant
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement
研究概览
简要总结
Long-term follow-up of IDE patients for publication
详细描述
This device (Hedrocel AVN Intervention Implant) was approved via 510(k) on April 15, 2005. One site was left open to follow patients to 5 year follow-up for publication of device survivorship.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient qualifies for core decompression based on physical exam
- •No history of core decompression
- •Patient is willing and able to provide written informed consent
排除标准
- •Patient has been diagnosed as Stage 0, III, IV, V or VI using the Steinberg/UPenn staging system.
- •Patient's BMI is >40
- •Patient is mentally compromised
- •Patient has neurological condition in ipsilateral or contralateral limb, which affect lower limb function
- •The patient has had a proximal femoral osteotomy or internal fixation in the affected hip.
- •The patient has undergone previous treatment for AVN
- •Previous hip conditions
- •Patient's bone stock is insufficient
- •Patient has diagnosed systemic disease
- •Patient is a pregnant female
- •Patient is unable or unwilling to attend postop follow-up visits
- •Patient has received investigational drug within the previous 6 months or an investigational device within the last 12 months
- •Patient has an active or latent infection
- •Patient has metal sensitivity
- •Patient is a prisoner
结局指标
主要结局
Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement
时间窗: 5 Year Follow-up
次要结局
未报告次要终点
研究者
研究点 (1)
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