臨床研究等提出・公開システム

Wear of 32mm Oxidized Zirconium (OXINIUM) head on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study (32mmOX multicenter study)

Wear of 32mm OXINIUM head on XLPE: Multicenter RCT Study (32mmOX multicenter study)

284

A total of 251 subject hips were included in the analysis, excluding 11 subjects with inappropriate informed consent process, 20 subjects who were not allocated to the intervention, and 2 subjects from site where the study was discontinued. The mean age was 63.2 years, 199 subject hips (79.3%) were female, and the primary diagnosis was secondary osteoarthritis in 191 (76.1%), primary osteoarthritis in 24 (9.6%), idiopathic osteonecrosis of the femoral head in 20 (8.0%), and others including 1 missing in 16 (6.4%). For the serious nonconformities observed in this study, appropriate measures were taken, including investigation of the causes, measures to prevent recurrence, and explanation to the subjects, based on the opinions of the Certified Review Board (CRB).

251 subject hips were enrolled in this study from October 2012 to March 2015 (excluding 33 subjects excluded from analysis). 125 and 126 subject hips were randomized to OXINIUM femoral head (OX) group and cobalt-chromium alloy femoral head (CoCr) group, respectively, then surgery and follow-up were conducted.

No adverse events associated with this study were observed.

The primary endpoint of polyethylene liner wear at 5 years postoperatively was an average of -0.158 mm (SD: +/- 0.815 mm, Median: -0.091 mm) in the OX group (77 subject hips) and -0.149 mm (SD: +/- 0.742 mm, Median: -0.093 mm) in the CoCr group (71 subject hips). No statistically significant difference between the 2 groups (p = 0.9459) observed. The secondary endpoint, PRO(Patient Reported Outcome: UCLA Activity Score, Harris Hip Score, JHEQ Score, Oxford Hip Score and JOA Score), also showed no consistent trend in differences between the two groups.

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.

Nov. 30, 2022

No

TBD

https://jrct.mhlw.go.jp/latest-detail/jRCTs032180245

Kume Shinichiro

Kurume University Medical Center

155-1, Kokubumachi, Kurume-City, Fukuoka

skume@med.kurume-u.ac.jp

Haraguchi Toshiaki

Kurume University Medical Center

155-1, Kokubumachi, Kurume-City, Fukuoka

+81-942-22-6111

haraguchi_toshiaki@med.kurume-u.ac.jp

Complete

Sept. 28, 2012

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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.

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.

Both

Hip osteoarthritis, Rheumatoid arthritis

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)

Hip osteoarthritis, Rheumatoid arthritis

Randomize

Linear wear of polyethylene liner

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)

+81-45-370-7627

Feb. 08, 2019

none