HXLPE Vs CPE Cups Under 50 Years

NCT06706193 | Completed Phase 4

• 1 other identifier: HXLPE_50y
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (2)

• Linear wear (mm/y)

  10 years

• Volumetric wear (mm3/y)

  10 years

Secondary Outcomes (1)

• Cup survival (%)

  10 years

Study Arms (2)

Control group

ACTIVE COMPARATOR

Procedure: Total hip arthroplasty using CPE

Intervention group

EXPERIMENTAL

Procedure: Total hip arthroplasty using HXLPE

Interventions

Total hip arthroplasty using CPE PROCEDURE

Control group

Total hip arthroplasty using HXLPE PROCEDURE

Intervention group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• primary THA
• age under 50 years

You may not qualify if:

• THA due to an oncological condition

Sponsors & Collaborators

• Radboud University Medical Center: lead

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 26, 2024
• Study Start: October 1, 2010
• Primary Completion: February 28, 2023
• Study Completion: July 1, 2023
• Last Updated: November 26, 2024

Record last verified: 2024-11