Wear Resistance of Highly Crosslinked Cemented Polyethylene Cups in Young Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 59
- 主要终点
- Linear wear (mm/y)
研究概览
简要总结
This randomized controlled trial evaluated the long-term wear of cemented highly cross-linked polyethylene (HXLPE) versus conventional polyethylene (CPE) acetabular cups in patients under 50 years undergoing primary total hip arthroplasty (THA).
All surgeries were performed at Radboud University Medical Center by three surgeons using a posterolateral approach. Acetabular components included either highly cross-linked polyethylene (HXLPE) cups (X3 RimFit) or conventional polyethylene (CPE) cups (Exeter Contemporary Flanged). Both were implanted with bone cement, and femoral components consisted of Exeter V40 stems with 28 mm cobalt-chromium heads. Impaction bone grafting (IBG) was routinely used, with mesh applied in cases of acetabular bone defects.
Radiographs were taken preoperatively and at 10-year follow-up using standardized protocols. Polyethylene wear was assessed with PolyWare software, creating 3D models from baseline and 10-year radiographs to calculate linear and volumetric wear. Cup inclination and osteolysis were evaluated in three acetabular zones (DeLee and Charnley classification).
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
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 50 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary THA
- •age under 50 years
排除标准
- •THA due to an oncological condition
研究组 & 干预措施
Control group
干预措施: Total hip arthroplasty using CPE (Procedure)
Intervention group
干预措施: Total hip arthroplasty using HXLPE (Procedure)
结局指标
主要结局
Linear wear (mm/y)
时间窗: 10 years
Volumetric wear (mm3/y)
时间窗: 10 years
次要结局
- Cup survival (%)(10 years)
