Prospective, Multicentre, Non-randomised, Open Study Evaluating the Efficacy and Fixation of the Mpact 3D Metal Monolit Cup
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 3
- 主要终点
- Evaluation of the hip function
研究概览
简要总结
Total hip arthroplasty (THA) is one of the most common operations performed in orthopaedics to improve a patient's quality of life.
Surgeons are constantly seeking to improve all aspects of care related to this procedure, whether it be improving implant technology, improving instrumentation or the technique involved in performing the procedure.
In recent years, a new porous titanium coating has been introduced to promote good osseointegration of uncemented cups. High friction torque and a feeling of immediate anchorage provide excellent primary stability, while high porosity ensures bone growth providing secondary stability. With higher porosity than standard coatings, a greater volume of bone can be present in the porous surface, giving a proportional increase in force at the interface. he Mpact 3D Metal Monolith cup has been designed to provide greater range of motion and improved joint stability, with a reduced risk of dislocation. It is an innovative design that improves stability and provides a favourable environment for long-term biological metal-bone fixation.
The current study aims to collect clinical and radiological data to assess the function of the operated hip and the stability of the Mpact 3D Metal Monolith cup at 2 years and survival at 5 years for the treatment of patients requiring hip arthroplasty.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a disease that corresponds to the indications for use of Medacta implants (according to the instructions for use)
- •Patient eligible for primary total hip arthroplasty
- •Patient aged between 18 and 75 years
- •Patient covered by the French Social Security system or an equivalent protection scheme.
- •Patient able, in the investigator's opinion, to comply with the requirements of the study.
排除标准
- •Patient suffering from inflammatory arthritis
- •Previously operated hip
- •Patient requiring a transplant
- •Hip tumour involved
- •Patient with progressive local or systemic infection
- •Severe acetabular dysplasia
- •Patient with muscle loss, neuromuscular disease or vascular impairment of the affected limb.
- •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 impairment that prevents him/her from fully understanding the requirements of the study
- •Patient living in a geographical area where study follow-up is not possible.
- •Patient taking part in interventional research
- •Minor patient
- •Protected adult patient
- •Vulnerable person according to article L1121-6 of the Public Health Code
结局指标
主要结局
Evaluation of the hip function
时间窗: Preoperative, 3 months, 6 months, 1 year, 2 years, 5 years
The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The original version was published 1969\[1\]. The HHS is an outcome measure administered by a qualified health care professional, such as a physician or a physical therapist. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
次要结局
- Analysis of the primary stability of the implant at 2 years(2 years)
- Analysis of the wear of the polyethylene insert (HighCross) at 2 years(2 years)
- Evaluation of the fixation and osteolysis(Immediate postoperative, 3 months, 6 months, 1 year, 2 years, 5 years)
- Evaluation of the mobility(Preoperative, 3 months, 6 months, 1 year, 2 years, 5 years)
- Evaluation of the safety of the implant(Intraoperative, immediate postoperative, 3 months, 6 months, 1 year, 2 years, 5 years)
- Evaluation of the survival of the implant(3 months, 6 months, 1 year, 2 years, 5 years)