Evaluation of Predictive Factors for Ruptures of Meije Duo ™ Size 1 and 2 Femoral Stems in Hip Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 8
- 主要终点
- Pourcentage of participants who had stem (Meije DuoTM size 1 or 2) breakage occured between implantation and the study follow-up call phone.
研究概览
简要总结
A normative development concerning the mechanical resistance tests of the the femoral stems led to contraindicate, in September 2014, to implant Meije Duo ™ femoral stems size 1 or 2 in patients weighing more than 60 kg due to an assumed risk of femoral stem breakage.
This contraindication is based on standardized mechanical tests which may have not taken into account the changes in patient weight that may occur after the intervention.
To date, investigators have not been aware of any Meije Duo ™ size 1/2 brakeage in our patients implanted with this type of prosthesis regardless of their weights before 2014. However, it is possible that some of them have had a prostheses failure and consulted another hospital. In the absence of a clinical study on this problem, investigators decided to set up a health care assessment study collecting retrospective and prospective information from our patients.
详细描述
First, patients with Meije Duo ™sizes 1 or 2, who had surgery from 2007 to 2014, will be preselected on medical records.
The information notice will be sent to them by post. A period of reflection will be respected before contacting the patient to answer their questions concerning the research and its progress and obtain their oral consent to participate in the study.
After obtaining consent, investigators will enter the retrospective data collected in the medical and prospective file collected during this call.
Patients with at least one of the following criteria: weight> 60 kg and / or long neck / varus and / or DEVANE score ≥ 4, will be selected to have a hip X-ray which will be specially scheduled for the study.
This examination will tell us about the state of the prosthesis and of the underlying bone (broken stem, loosening of the implant, bone fracture, dislocation, border, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •An x-ray of the hip concerned will be performed on all consenting patients, having at least one criterion of the following three during their medical history since the implantation of the hip prosthesis.
- •Weight> 60 kg
- •DEVANE score ≥ 4
- •Long neck / varus
排除标准
- •The patient expresses his opposition to the use of his personal data
- •Patients (<18 years old)
- •Patients unable or out of state to express their consent
- •Patient unable to speak French
- •Patient with memory impairment or cognitive impairment
- •Patient not affiliated to a social security or equivalent health coverage
结局指标
主要结局
Pourcentage of participants who had stem (Meije DuoTM size 1 or 2) breakage occured between implantation and the study follow-up call phone.
时间窗: Up to 4 weeks, starting from the call phone (patient consent)
The number of stem breakage that occured since prostheses implantation will be collected by asking every participant during the follow-up call phone and performing hip xray to eligible ones (see above)
次要结局
- The change of the weight and the body mass index (BMI) of the patients after the implantation of Meije DuoTM rods size 1 or 2(Change from baseline weight and BMI at postoperative 4 years)
- The change of physical activity in participants from baseline (prostheses implantation) to study call-phone point time.(Change from baseline Devane score at postoperative 4 years)
- Pourcentage of participants who had other prostheses failures (loosening of the prosthesis, femoral fracture, dislocation)(Up to 4 weeks, starting from the call phone (patient consent))
研究者
SMARMOR
orthopedic surgeon
Groupe Hospitalier Diaconesses Croix Saint-Simon