NCT03681639已完成不适用
A Multi-Centre, Prospective Study to Obtain Survival and Clinical Outcome Data on the Zimmer Hip Resurfacing System Utilising the Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Implant Survival
研究概览
简要总结
The Zimmer Hip Resurfacing System Post-Market Clinical Follow-up study will examine the safety and efficacy of this device in the young and/or active patient with advanced hip disease.
详细描述
This is a multi-center, prospective, non-controlled post market surveillance study. The objective of this study is to obtain survival and outcome data on the Zimmer Hip Resurfacing System. This will be assessed by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and efficacy of the Zimmer Hip Resurfacing System. Serum metal ion levels (cobalt and chromium) will also be collected pre-operatively and again at 6 months, 1 year, 2 years and 5 years. This procedure will offer an option to these patients who would otherwise require and likely outlive a conventional total hip replacement.
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 ≥ 18 and ≤ 65 years of age.
- •Female patients only, if
- •Actively practicing a contraceptive method, or
- •Surgically sterilized, or
- •Post-menopausal
- •Pre-operative Harris Hip Score ≤
- •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, which may include 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 an Ethics Committee approved Informed Consent.
排除标准
- •Patient has an acute, chronic, local or systemic infection.
- •Patient is skeletally immature.
- •Patient is known to be pregnant.
- •Patient has a severe muscular, neural or vascular disease that endangers the involved extremity.
- •Patient has 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), or
- •patients with local bone tumors and/or cysts of the femoral head > 1 cm
- •Patient has a total or partial absence of the muscular or ligamentous apparatus.
- •Patient has known moderate to severe renal insufficiency.
- •Patient has a known clinical condition which may interfere with the patient's outcome, including but not limited to:
- •immunocompromised conditions (AIDS),
- •organ transplant,
- •high doses of corticosteroids etc
- •Patient is severely overweight (BMI > 40)
- •Patient is scheduled for simultaneous bilateral total hip replacement.
- •OPERATIVE (IPSILATERAL) HIP: Patient has a total prosthetic hip replacement device, surface arthroplasty, endoprosthesis or femoral and/or acetabular osteosynthesis.
- •CONTRALATERAL HIP: Patient has had a hip replacement, surface arthroplasty or endoprosthesis, within the past 12 months, unless previously enrolled in this clinical study.
- •Patient is:
- •a prisoner,
- •mentally incompetent,
- •a known alcohol or drug abuser,
- •anticipated to be non-compliant
- •Patient has participated in a study of any other investigational device (drug, device or biologic) within the past 12 months. Exception: previous enrollment in the Zimmer Hip Resurfacing clinical study.
- •Patient has a known allergy to one of the constituents of the implant, e.g. cobalt, chromium, nickel, etc.
结局指标
主要结局
Implant Survival
时间窗: 10 years post-surgery
The primary endpoint for this study is implant survival at 10 years which is assessed by revision of the Metasul Monoblock Component Cup calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component.
次要结局
- Patient's Activity Level Determined by UCLA Score(Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery)
- Harris Hip Score(Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery)
- Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)(Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery)
- Radiographic Evaluation(Pre-op, 6 weeks, 1,2,3,5,7 and 10 years post operatively 2, 3, 5, 7 and 10 years post-operatively. 2, 3, 5, 7 and 10 years post-operatively.)
- EuroQol 5 Dimension (EQ-5D)(Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery)
- Oxford Hip Score(Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery)
- Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery)
研究者
研究点 (2)
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