HXLPE Vs CPE Cups Under 50 Years

Wear Resistance of Highly Crosslinked Cemented Polyethylene Cups in Young Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06706193

Enrollment

Registered

2024-11-26

Start date

2010-10-01

Completion date

2023-07-01

Last updated

2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Hip

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).

Interventions

PROCEDURETotal hip arthroplasty using CPE

PROCEDURETotal hip arthroplasty using HXLPE

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

After obtaining informed consent, the participants were randomized to a surgical intervention with the use of 60 sealed envelopes which were opened by the surgeon in theatre just before surgery.

Eligibility

Sex/Gender

ALL

Age

16 Years to 50 Years

Healthy volunteers

Inclusion criteria

* primary THA * age under 50 years

Exclusion criteria

* THA due to an oncological condition

Design outcomes

Primary

Measure	Time frame
Linear wear (mm/y)	10 years
Volumetric wear (mm3/y)	10 years

Secondary

Measure	Time frame
Cup survival (%)	10 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026