NCT01429805已完成不适用
Balloon Assisted Hip Arthroscopy - Clinical Evaluation of a New Tool for Hip Arthroscopy
Pivot Medical Inc.3 个研究点 分布在 3 个国家目标入组 30 人开始时间: 2011年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Ability to access the central compartment of the hip and maintain intra-articular hip joint distraction with the HipJack Balloon Spacer during hip arthroscopy.
研究概览
简要总结
The purpose of this study is to obtain information on the safety and performance of HipJack Balloon Spacer to access the central compartment of the hip and maintain intra-articular hip joint distraction during arthroscopy of the central compartment of the hip.
详细描述
The HipJack Kit is intended to maintain distraction of the joint during hip arthroscopy. This study will evaluate the Kit in clinical sites outside of the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Age ≥ 18 years
- •Scheduled for unilateral arthroscopic procedure of the hip
排除标准
- •Active infection sepsis or osteomyelitis
- •Body mass index (BMI) of 40 or greater
- •Open wounds of the hip or leg area
- •Moderate or severe degenerative hip disease or hip joint space <3 mm
- •Large pincer, coxa profunda or protrusio
- •Retroverted acetabulum
- •Compromised ligamentum teres or ligamentum teres dysplasia
- •Previous hip surgery or arthroscopy on the target hip
- •Hip injury due to high-energy trauma
- •Hip fracture or hip dislocation on the target hip
- •Metabolic disorders that may impair bone formation
- •Osteomalacia or moderate to severe osteoporosis, rapid joint destruction, marked bone loss or bone resorption noted on x-ray
- •Severe neurosensory deficits
- •Inadequate joint space distraction with external traction to allow for insertion of HipJack device
- •Any condition that is a relative or absolute contraindication to hip arthroscopy
- •Pregnant or lactating
- •History of venous thrombosis or known coagulopathy
结局指标
主要结局
Ability to access the central compartment of the hip and maintain intra-articular hip joint distraction with the HipJack Balloon Spacer during hip arthroscopy.
时间窗: Treatment (Day 0)
次要结局
- Reduction in external traction time.(Treatment (Day 0))
- Investigator-related adequacy of central compartment visualization with use of the investigational device.(Treatment (Day 0))
- Investigator-rated adequacy of maneuverability of arthroscopy tools with the investigational device inflated in the central compartment.(Treatment (Day 0))
- The occurrence of serious adverse events by 6-week follow-up rated by the investigator to be probably or definitely related to the investigational device.(6 weeks)
研究者
研究点 (3)
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