Evaluation of the Positioning of the Dynacup Cup "One C" Versus Standard Dynacup
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- To Compare the positioning accuracy of the Dynacup One C (pre-assembled version) with that of the standard Dynacup.
研究概览
简要总结
The ceramic-ceramic friction pair is widely used today in total hip arthroplasty, including fourth-generation ceramics which show the lowest wear rate. These have considerably reduced the risk of head fracture compared to previous generations; however, the risk of insert rupture persists with rates similar to those of third generation ceramics.
These ceramic fractures require complex revision surgery, which brings complications, exposing patients to the risk of third-body wear and tear related to persistent post-surgical debris. They are frequently due to an incorrect assembly of the ceramic causing intraoperative or early postoperative rupture. To fix this, manufacturers have developed pre-assembled cups in the factory. The Dynacup One C cup developed by Corin® corresponds to the pre-assembled version of the Dynacup cup, making it possible to eliminate the risk of anomaly during intraoperative assembly linked to the human factor and to offer patients with very small cups an adapted ceramic implant. A single study with a small sample compared the two implants (pre-assembled version [vs] modular version) clinically, radiologically and functionally without showing any significant difference. The lack of data in the literature comparing these two implants motivated us to conduct a randomized comparative study on a large sample of patients.
详细描述
Patients eligible for a total hip arthroplasty with a ceramic-ceramic friction couple and scheduled for surgery will be included in this study after information and collection of written consent.
After randomization, a preoperative radiograph with a calibration ball will be taken to plan the prosthesis and identify the characteristics of the operated hip.
An x-ray of the pelvis with a 28 mm ball will be carried out the day after the intervention according to the same preoperative procedures in order to measure the postoperative radiographic parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Adult man and woman > 18 years old
- •Indication for hip arthroplasty with a Dynacup One C or standard Dynacup cup
- •Patient informed of the study and signed a consent form
排除标准
- •Refusal to participate in the study
- •Indication of a friction couple other than ceramic-ceramic
- •Contraindication or the technical impossibility of implanting an impacted acetabular component
- •Pregnant or breastfeeding women.
- •Minor patients aged < 18 years
- •Subjects not affiliated to the national health insurance or to an equivalent insurance
结局指标
主要结局
To Compare the positioning accuracy of the Dynacup One C (pre-assembled version) with that of the standard Dynacup.
时间窗: Perioperative
Radiographic measurement of the position of the center of rotation of the final implant, its inclination and its anteversion, compared to the positioning planned before the intervention for the 2 types of implants.
次要结局
- To describe the rate of intraoperative secondary re-impactions of both groups(Perioperative)
- To describe the rate of intraoperative complications according to the type of implant(Perioperative)
- To describe the rate of insufficient impaction of the acetabulum in both groups(Perioperative)
- Indentify predictors for insufficient impaction of the acetabular implant(Perioperative)
研究者
SMARMOR
MD
Groupe Hospitalier Diaconesses Croix Saint-Simon