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临床试验/NCT06706193
NCT06706193已完成4 期

Wear Resistance of Highly Crosslinked Cemented Polyethylene Cups in Young Patients

Radboud University Medical Center0 个研究点目标入组 59 人开始时间: 2010年10月1日最近更新:
适应症
干预措施

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

Active Comparator

干预措施: Total hip arthroplasty using CPE (Procedure)

Intervention group

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

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