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Completed

NCT Number: NCT06706193

HXLPE Vs CPE Cups Under 50 Years

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).

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Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary THA
  • age under 50 years

Exclusion criteria

  • THA due to an oncological condition

Treatment and study plan

Total hip arthroplasty using CPE

Procedure

Total hip arthroplasty using HXLPE

Procedure

Primary outcomes

  1. Linear wear (mm/y)

    Time frame: 10 years

  2. Volumetric wear (mm3/y)

    Time frame: 10 years

Secondary outcomes

  1. Cup survival (%)

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Wear Resistance of Highly Crosslinked Cemented Polyethylene Cups in Young Patients

Important dates

Study start
2010
Primary completion
2023
Study completion
2023
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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