Wear of OXINIUM on XLPE: Multicenter RCT Study
- Conditions
- Hip osteoarthritis, Rheumatoid arthritis
- Registration Number
- JPRN-jRCTs032180273
- Lead Sponsor
- Akiyama Haruhiko
- 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 was observed in the amount of polyethylene liner wire wear and PRO between the two groups. Since other national registries have suggested the superiority of OXINIUM femoral heads (Reduction of the revision rate with loosening), further discussion of differences between the studies and the validity of this study design is necessary.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1302
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 28mm femoral head.
5. Patient with UCLA score higher than 3.
6. Patient who has Japanese nationality.
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, Oxford Hip Score, Surgical record, Adverse event