HXLPE Vs CPE Cups Under 50 Years

Radboud University Medical Center

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Hip

Treatments: Procedure: Total hip arthroplasty using HXLPE; Procedure: Total hip arthroplasty using CPE

Study type: Interventional

Funder types: Other

Identifiers

NCT06706193

HXLPE_50y

Details and patient eligibility

About

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).

Enrollment: 59 patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary THA
• age under 50 years

Exclusion criteria

• THA due to an oncological condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 2 patient groups

Control group

Active Comparator group

Treatment:

Procedure: Total hip arthroplasty using CPE

Intervention group

Experimental group

Treatment:

Procedure: Total hip arthroplasty using HXLPE