NCT04172129已完成不适用
Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study
Smith & Nephew Orthopaedics AG1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年4月26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
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of migration pattern of the Nanos stem
研究概览
简要总结
The primary purpose of this study was to evaluate the implant fixation of the NANOS™ Neck Preserving Hip Stem (OHST Medizintechnik AG, distributed by Smith & Nephew GmbH, Marl, Germany) by measuring the migration of the implant using the model-based roentgen stereophotogrammetric analysis (MBRSA).
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject required primary total hip arthroplasty unilateral or bilateral with a diagnosis of primary and secondary coxarthrosis, dysplasia coxarthrosis and post-traumatic necrosis of the femoral head confirmed by x-ray analysis. For bilateral subjects at least three months between surgical procedures were required.
- •Subject was willing to consent to participate in the study and planned to be available for the follow-up examinations.
- •Subject had normal motor function of the lower extremities, documented through clinical examinations and lack of signs of a neurological disease with changed motor function.
- •Subject was 30 to 65 (inclusive) years of age at time of surgery.
排除标准
- •Subject had previous bone or soft tissue surgery of the affected hip except for arthroscopic surgery.
- •Subject had a local or systemic infection.
- •Subject had previously diagnosed osteoporosis.
- •Subject had a femoral neck angle of >145°.
- •Subject had a femoral neck angle of <125°.
- •Subject had a disease of the cardiovascular system involving particularly reduced load capacity in the everyday life, counting as contraindication of physical stress (American Society of Anaesthesiologists' (ASA) Score 3 or 4).
- •Subject had a documented allergy against elements of the implanted device.
- •Subject had a neurological disease with changed motor function.
- •Subject was pregnant.
- •Subject had a Body Mass Index (BMI) >
- •Subject suffered from alcoholism or addictive disorders.
- •Subject needed a revision hip arthroplasty.
- •Subject had an insufficient command of the language to understand patient information and consent.
结局指标
主要结局
Evaluation of migration pattern of the Nanos stem
时间窗: 2 years
Measuring migration used the model-based RSA method
Change in quality of life
时间窗: 2 years
Measuring change in quality of life using the Short Form (SF) 36 Mental Component Score * Minimum Value: 0 (worst outcome) * Maximum Value: 100 (best outcome)
次要结局
- Pain Visual Analogue Scale(2 years)
- University of California, Los Angeles (UCLA) scale(2 years)
- Postel Merle d'Aubigné-Score(2 years)
- Radiographic Evaluation(2 years)
- Harris Hip Score(2 years)
- Hip Disability and Ostheoarthritis Outcome Score(2 years)
- Number of adverse events(2 years)
研究者
研究点 (1)
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