NCT05818891招募中不适用
Prospective, Multicenter, Non-Controlled, Non-Randomized, Open-Label Study To Evaluate The Efficacy And Performance Of The Mpact® Dual Mobility Hemispheric Cup
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty.
研究概览
简要总结
The primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty.
The primary endpoint is the 10-year life span of the prosthesis according to the Kaplan Meier curve.
详细描述
The primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty evaluated through the Kaplan Meier curve.
The secondary objectives of the study are:
- To assess the function of the operated hip
- Evaluate the safety of the implant
- Evaluate the stability of the prosthetic components
Secondary endpoints were:
- Harris Hip Score The Harris Hip Score (HHS) items include an analysis of the operated hip according to pain, function, mobility and stability and a deformity analysis. The Harris Hip Score will be used to assess the patient's subjective and objective improvement in the above criteria.
- Evaluation of standard radiographs from the front and side. Periprosthetic edging and osteolysis will be evaluated using Delee and Charnley zones for the acetabular component and Gruen zones for the femoral component.
- Evaluation of implant stability and fit using the ARA score. This score is used to determine whether the implant causes changes in the surrounding bone structures. If signs occur, they can be considered either as "neutral", showing a simple adaptation and not reducing the result, or as "negative" to varying degrees. The maximum ARA score is 6 points, negative points from 1 to 4 can be attributed for each of these "negative" signs.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a disease that meets the indications for use of Medacta implants (according to the instructions for use)
- •Patient eligible for first-line total hip replacement
- •Patient between 18 and 80 years of age
- •Patient covered by the Social Security system or an equivalent protection plan
- •Patient who is capable, in the opinion of the investigator, of fulfilling the requirements of the study
排除标准
- •Patient requiring a transplant
- •Patient with progressive local or systemic infection
- •Patient with muscle loss, neuromuscular disease, or vascular impairment of the affected limb making surgery unwarranted
- •Patient with known medical problems that may compromise independent recovery of mobility
- •Patient with a BMI greater than 40 kg/m².
- •Patient with major cognitive problems that do not allow a good understanding of the study requirements
- •Patient living in a geographical area that does not allow the study follow-up
- •Patient participating in interventional research.
- •Minor patient
- •Protected adult patient
- •Vulnerable person according to article L1121-6 of the Public Health Code
- •Pregnant or nursing woman.
结局指标
主要结局
Evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty.
时间窗: 10 years after the index surgery
Analysis with Kaplan Meier curve considering the revisions of the implants
次要结局
- Evaluate the function of the operated hip(pre-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery)
- To evaluate the safety of the implant(Intra-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery)
- To evaluate the stability of the prosthetic components(pre-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery)
研究者
研究点 (1)
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