Evaluation of the Safety and Efficiency of the Metaphyseal Hip Prosthesis - Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- RSA Translation Z
研究概览
简要总结
The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement.
详细描述
The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement at short term (1 year) and long term (10 years).
Bone remodeling will be analyzed at 10 years using DEXA (Dual Energy X-Ray Absorptiometry (bone scan test)) measurements.
This is a single-center prospective study with 25 patients in the study and 25 in the control group in open Randomized Clinical Trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for a total hip replacement because of arthritis of the hip
- •Patients with a good general condition
- •Patients willing and able to participate in the clinical trial with a 10 years follow up and who have signed an inform consent
- •Males and females
- •Age between 55 and 75
- •Absence or little presence of osteoporotic bone (t>-2)
- •ASA score 1 and 2
排除标准
- •Patient with co morbidities that limit the physical abilities which may negatively influence the scores. Such co morbidities can for example be cardiac insufficiency or chronic respiratory diseases.
- •Severe systematic diseases such as rheumatic arthritis and SLE.
- •General osteoporosis (t<-2).
- •Hormonal conditions such as Paget disease, which reduces the bone density.
- •Diseases that can negatively influence the 10 years life expectancy.
- •Chronic use of corticosteroids.
- •Extreme overweight defined as BMI above
- •Active bacterial infection.
- •Mental weakness which could negatively influence the postoperative recovery and influence the ability to complete pain scores and other questionnaires.
- •ASA score >2.
研究组 & 干预措施
Stanmore
25 patients will have the Stanmore prosthesis
干预措施: Stanmore (Device)
Metaphyseal Hip Prosthesis
25 patients will have the Metaphyseal Hip Prosthesis (MHP) prosthesis
干预措施: Metaphyseal Hip Prosthesis (Device)
结局指标
主要结局
RSA Translation Z
时间窗: 3 months, 6 months, 1 year and 2 years postoperatively
Stem movement along z-axis in mm (measured with RSA)
RSA MTMP
时间窗: 3 months, 6 months, 1 year and 2 years postoperatively
Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem.
RSA Translation X
时间窗: 3 months, 6 months, 1 year and 2 years postoperatively
Stem movement measured with RSA (radiostereometric analysis) along the x-axis in mm. RSA is a technique to accurately measure 3D movement of the prosthesis in the bone. The movement is measured with respect to the situation directly postoperative.
RSA Translation Y
时间窗: 3 months, 6 months, 1 year and 2 years postoperatively
Stem movement along the y-axis in mm. (measured with RSA)
RSA Rotation X
时间窗: 3 months, 6 months, 1 year and 2 years postoperatively
Stem Rotation around X-axis in degrees (measured with RSA)
RSA Rotation Y
时间窗: 3 months, 6 months, 1 year and 2 years postoperatively
Stem rotation around the y-axis in degrees ( measured with RSA)
RSA Rotation Z
时间窗: 3 months, 6 months, 1 year and 2 years postoperatively
Stem rotation around the z-axis in degrees (measured with RSA)
次要结局
- Harris Hip Score(pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- DEXA(1 and 2 years postoperative)
- HOOS-Pain Subscale(pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- HOOS-Symptom Subscale(pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- HOOS-ADL Subscale(pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- HOOS-Sport Subscale(pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- HOOS-QoL Subscale(pre-operatively, 6 weeks, 3 months, 6 months, 1,2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- SF-12 Physical Summary Score(pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- SF-12 Mental Summary Score(pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- Number of Reported Device Related Complications(6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, 10 years postoperatively)