NCT04036279终止不适用
A Prospective, Multicenter, Clinical Outcome Study of the NANOS Neck Preserving Stem in Patients With Degenerative Hip Joint Disease
Smith & Nephew Orthopaedics AG3 个研究点 分布在 3 个国家目标入组 130 人开始时间: 2010年1月21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
- 130
- 试验地点
- 3
- 主要终点
- Long term survivorship of Nanos
研究概览
简要总结
The objective of this study is to determine the long-term safety and effectiveness of the NANOS neck preserving stem in terms of radiographic and clinical performance as well as short-, mid- and long-term survivorship
详细描述
The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the NANOS neck preserving hip stem.
Effectiveness Measures:
- Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, HOOS Score [4-6], UCLA Activity Rating [7]
- Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration
Safety evaluations:
- Intra- and peri-operative device-related adverse events (AE) and complications up to discharge
- Postoperative AE up to 10 years
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Inclusion criteria:
- •Patient requires Primary total hip replacement (THR) to the affected side, unilateral or bilateral. Bilateral only if >3 months after the first THR
- •Patient agreed to participate in the MCO study by signing the Informed Consent form.
- •Age of patient at date of surgery 18 to 65 years
- •Patient is likely to comply with study follow-up requirements
- •Exclusion criteria:
- •Previously failed endoprosthesis and /or THR components in relevant hip
- •Patient has proven osteoporosis
- •Pronounced coxa valga with a femoral neck angle > 145º
- •Pronounced coxa vara with a femoral neck angle < 125º
- •History of infection in the affected joint; systemic infections
- •Grossly insufficient femoral or acetabular bone stock in the involved hip where a revision cup is indicated
- •Spinal disease with neurologic movement disorders
- •Alcoholism or addictive disorders
- •ASA score is 3 or 4
- •Body mass index (BMI) > 30
- •Patient is pregnant or being pregnant during follow up intervals
- •Patients understanding of the language is insufficient for understanding the Patient Information and Consent
排除标准
- 未提供
结局指标
主要结局
Long term survivorship of Nanos
时间窗: 10 years
Revision for any reason. Implant survivorship at 10 years post study procedure. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants
次要结局
未报告次要终点
研究者
研究点 (3)
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