NCT00746616已完成3 期
Durom(R) Hip Resurfacing System Multicenter Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Device Survival
研究概览
简要总结
The purpose of the study is to gather clinical information on the safety and efficacy of the resurfacing devices in the young, active patient with advanced hip disease. Study enrollment has been temporarily suspended due to a change in the surgical technique.
详细描述
Safety will be evaluated based on the frequency and incidence of any device related adverse events or unanticipated adverse device events. The efficacy will be measured by comparing the overall functional performance based on the Harris Hip Score, implant survivorship, and radiographic parameters, including radiolucencies, osteolysis, stem subsidence, cup migration, and change in cup angle and a change in the femoral shaft angle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient selection without bias to race or gender
- •Patient is greater than or equal to 18 and less than or equal to 65 years of age.
- •Female patients only:
- •actively practicing a contraceptive method, or
- •surgically sterilized, or
- •post-menopausal
- •Pre-operative Harris Hip Score less than or equal to
- •Primary surgical hip candidate, suffering from hip pain and/or disability due to degenerative joint disease (inflammatory or non-inflammatory), based on physical examination and history, including the following diagnosis:
- •non-inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis or osteoarthritis
- •inflammatory joint disease (IJD), e.g. rheumatoid arthritis
- •Patient is willing and able to cooperate in prescribed post-operative therapy.
- •Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
- •Patient has participated in the Informed Consent process and has signed and IRB approved Informed Consent.
排除标准
- •Patient with an acute, chronic, local or systemic infection.
- •Patient who is skeletally immature.
- •Patient with a severe muscular, neural or vascular disease that endangers the involved extremity.
- •Patient with an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible, including but not limited to:
- •patient with severe osteopenia
- •patients with a family history of severe osteoporosis or osteopenia
- •patients with osteonecrosis or avascular necrosis (AVN) with > 50% involvement of the femoral head (regardless of FICAT grade)
- •patients with multiple cysts of the femoral head > 1cm
- •Patient with total or partial absence of the muscular of ligamentous apparatus.
- •Patient has known moderate to severe renal insufficiency.
- •Patient with a known clinical condition which may interfere with patient outcome, including but not limited to:
- •immuno-compromised conditions (AIDS),
- •organ transplant recipient,
- •high doses of corticosteroids etc
- •Patient who is severely overweight (BMI >40)
- •Operative (ipsilateral) Hip: Patient has a total prosthetic hip replacement device, surface arthroplasty or endoprosthesis.
- •Contralateral Hip: Patient has had hip replacement, surface arthroplasty or endoprosthesis, within the past 12 months, unless already enrolled in this investigational study.
- •Patient who is:
- •a prisoner
- •mentally incompetent
- •a known alcohol or drug abuser
- •anticipated to be non-compliant
- •Patient who has participated in a study of any other investigational device (drug, device or biologic) within the past 12 months. Exception: previous enrollment in the Durom Hip Resurfacing System clinical study.
- •Patient has a known allergy to one of the constituents of the implant, e.g. cobalt, chromium, nickel, etc.
研究组 & 干预措施
1
Experimental
Hip resurfacing devices in the young, active patient with advanced hip disease instead of traditional total hip arthroplasty.
干预措施: Durom Hip Resurfacing System (Device)
结局指标
主要结局
Device Survival
时间窗: All post-op visits until last patient enrolled reaches 2 year follow-up
次要结局
- Efficacy(6 month post-op and annually until last patient reaches 2 year follow-up)
研究者
研究点 (10)
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