Dual Mobility Acetabular Cups in Revision TJA
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 322
- 试验地点
- 3
- 主要终点
- Prosthetic Dislocation
研究概览
简要总结
The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.
详细描述
The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Any patient older than 18 years of age scheduled for a revision THA, including revision of both components, conversion of a hip resurfacing to THA, conversion of a hemiarthroplasty to THA, and revision of single components which allow implantation of dual-mobility bearings. In addition, patients undergoing reimplantation of a total hip arthroplasty following a two-stage revision for periprosthetic infection will also be included. Only patients with an acetabular shell diameter capable of accommodating at least a 36mm femoral head will be included.
排除标准
- •Less than 18 years of age, primary THA,
- •conversion of non-arthroplasty femoral neck fracture fixation to THA,
- •patients unwilling to participate.
- •patients where the surgeon makes the intraoperative decision to use a constrained liner will be excluded.
结局指标
主要结局
Prosthetic Dislocation
时间窗: 20 years
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
次要结局
- Routine radiographs assess for loosening and proper component placement(20 years.)
- Complications(up to 20 years after the patient is discharged from the hospital)