NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032180273

Registered date:14/03/2019

Wear of OXINIUM on XLPE: Multicenter RCT Study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedHip osteoarthritis, Rheumatoid arthritis
Date of first enrollment11/07/2011
Target sample size1308
Countries of recruitment
Study typeInterventional
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 OutcomeLinear wear of polyethylene liner
Secondary OutcomeCase background, X-ray evaluation (Bone form, Implant installation position, Bone reaction), Harris Hip Score, UCLA Score, Oxford Hip Score, Surgical record, Adverse event

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
GenderBoth
Include criteria1. 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.
Exclude criteria1. 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

Contact

Public contact
Name Haruhiko Akiyama
Address 1-1 Yanagido, Gifu city, Gifu Gifu Japan 501-1194
Telephone +81-58-230-6330
E-mail hakiyama@gifu-u.ac.jp
Affiliation Gifu University Hospital
Scientific contact
Name Haruhiko Akiyama
Address 1-1 Yanagido, Gifu city, Gifu Gifu Japan 501-1194
Telephone +81-58-230-6330
E-mail hakiyama@gifu-u.ac.jp
Affiliation Gifu University Hospital