MedPath

HXLPE Vs CPE Cups Under 50 Years

Phase 4
Completed
Conditions
Osteoarthritis, Hip
Registration Number
NCT06706193
Lead Sponsor
Radboud University Medical Center
Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
59
Inclusion Criteria
  • primary THA
  • age under 50 years
Exclusion Criteria
  • THA due to an oncological condition

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Linear wear (mm/y)10 years
Volumetric wear (mm3/y)10 years
Secondary Outcome Measures
NameTimeMethod
Cup survival (%)10 years
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