Wear of 32mm OXINIUM head on XLPE: Multicenter RCT Study

Phase 4

• Conditions: Hip osteoarthritis, Rheumatoid arthritis

• Registration Number: JPRN-jRCTs032180245
• Lead Sponsor: Kume Shinichiro

Brief Summary

In this study, subjects were assigned to femoral head groups with different materials and observed for 5 years after surgery. No significant difference between the two groups at 5 years after the operation, which was the primary endpoint. The secondary endpoint, PRO, also showed no consistent trend in differences between the two groups. The lack of accuracy of linear wear measurement software would be one of the factors that did not show a difference in the primary endpoint between the two groups.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-12
• Study Completion: 2020-08-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

1. Patient whose written consent was obtained to participate in the study.
2. Patient with indication for THA.
3. Patient aged 20 to 75 years old.
4. Patient able to implant 32mm femoral head.
5. Patient with UCLA score higher than 3.
6. Patient who has Japanese nationality.

Exclusion Criteria

1. Revision THA
2. Implantation of all-polyethylene cup
3. Patient unable to evaluate Oxford Hip Score
4. Patient expected to live less than 5 years, such as cancer patients and severe patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
inear wear of polyethylene liner

Secondary Outcome Measures

Name	Time	Method
Case background, X-ray evaluation (Bone form, Implant installation position, Bone reaction), Harris Hip Score, UCLA Score, Surgical record, Adverse event, Oxford Hip Score (option), JOA Hip Score (option), JHEQ Score (option)