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

JRCT ID: jRCTs032180245

Registered date:12/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hip osteoarthritis, Rheumatoid arthritis
• Date of first enrollment: 28/09/2012
• Target sample size: 352
• Study type: Interventional

Intervention(s)

Arm A: Oxidized zirconium alloy (OXINIUM) femoral head
Arm B: Standard cobalt chromium alloy head
Random allocation is registered automatically at the UMIN Internet Medical Research Data Center (INDICE)

Outcome(s)

• Primary Outcome: Linear wear of polyethylene liner
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kume Shinichiro
• Source(s) of Monetary Support: Smith and Nephew K.K.
• Secondary ID(s): UMIN000007309