NCT06706193

HXLPE Vs CPE Cups Under 50 Years

Wear Resistance of Highly Crosslinked Cemented Polyethylene Cups in Young Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Osteoarthritis, Hip

Interventions

Type	Name	Description
PROCEDURE	Total hip arthroplasty using CPE
PROCEDURE	Total hip arthroplasty using HXLPE

Timeline

• Start date: 2010-10-01
• Primary completion: 2023-02-28
• Completion: 2023-07-01
• First posted: 2024-11-26
• Last updated: 2024-11-26