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Clinical Trials/NCT06706193
NCT06706193
Completed
Phase 4

Wear Resistance of Highly Crosslinked Cemented Polyethylene Cups in Young Patients

Radboud University Medical Center0 sites59 target enrollmentOctober 1, 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Osteoarthritis, Hip
Sponsor
Radboud University Medical Center
Enrollment
59
Primary Endpoint
Linear wear (mm/y)
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 1, 2010
End Date
July 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • primary THA
  • age under 50 years

Exclusion Criteria

  • THA due to an oncological condition

Outcomes

Primary Outcomes

Linear wear (mm/y)

Time Frame: 10 years

Volumetric wear (mm3/y)

Time Frame: 10 years

Secondary Outcomes

  • Cup survival (%)(10 years)

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