NCT04831918已完成不适用
A Prospective Clinical Study Evaluating Clinical, Radiographic And Patient-Reported Outcomes Of THA With Cemented Acetabular Cups
Limacorporate S.p.a2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年3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
- 45
- 试验地点
- 2
- 主要终点
- Clinical progression of Harris Hip Score (HHS) from baseline to 2 years after surgery
研究概览
简要总结
This clinical study has the aim to evaluate clinical, radiographic, patient-reported outcomes of total hip arthroplasty with the implant of Mueller cemented acetabular cups up to 2 years after surgery, in order to assess the performance of the device. Furthermore, it aims to collect short-term survivorship of the implant and the incidence of early complications.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee;
- •The patient diagnosis is one or more of the following:
- •Patient with advanced articular destruction generated by primary degenerative or post-traumatic arthrosis or rheumatoid arthritis;
- •Patient with avascular necrosis of the femoral head or fracture of the femoral neck;
- •Patient with congenital or acquired deformity;
- •Patient with failures of previous operations, like osteosynthesis, articular reconstruction, arthrodesis, hemi-arthroplasty or total arthroplasty.
- •The patient is willing and able to complete scheduled follow-up evaluations as described in the Patient Information Sheet;
排除标准
- •The patient should be excluded from the study if he/she meets any of the following criteria, which reflect the cemented acetabular cup contraindication for use:
- •Acute or chronic infections, local or systemic infections;
- •Serious muscular, neurological or vascular diseases affecting the concerned limb;
- •Any concomitant disease and dependence that might affect the implanted prosthesis;
- •Allergy to material;
- •Metal-on-metal systems: patients with renal impairment.
- •Patient's age<18
- •Female patients who are pregnant, nursing, or planning a pregnancy.
结局指标
主要结局
Clinical progression of Harris Hip Score (HHS) from baseline to 2 years after surgery
时间窗: 2 years Follow up
HHS ranges from 0 to 100, being 0 the worst and 100 the best conditions. HHS is reported as 90-100 for excellent results, 80-90 for good, 70-79 for fair, 60-69 for poor, and below 60 for a failed result. The outcome is considered satisfactory for values over 80
次要结局
- Clinical progression of HOOS up to 2 years FU, compared to the baseline(6 weeks, 1 year and 2 years FU)
- Change in TUG from preoperative up to 2 years FU(6 weeks, 1 year and 2 years FU)
- Clinical progression of HHS up to 1 year FU, compared to the baseline(6 weeks, 1 year)
- Implant survivorship (Kaplan-Meier estimate) at 2 years after surgery(2 years FU)
- Radiographic evaluation and stability assessment of the implant up to 2 years FU(6 weeks, 1 year and 2 years FU)
- Incidence of device-related AE/SAE up to 2 years of follow-up(6 weeks, 1 year and 2 years FU)
研究者
研究点 (2)
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