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Wear of Oxidized Zirconium (OXINIUM) on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study (28mmOX multicenter study)

Wear of OXINIUM on XLPE: Multicenter RCT Study (28mmOX multicenter study)

1302

1056 subject hips were included in the analysis, excluding subjects with inappropriate informed consent process or subjects who were not allocated to the intervention. The mean age was 61.5 years, 852 subject hips (80.7%) were female, and the primary diagnosis was secondary osteoarthritis in 748 (70.8%), idiopathic osteonecrosis of the femoral head in 140 (13.3%), primary osteoarthritis in 101 (9.6%), and others including 4 missing in 67 (6.3%).

1056 subject hips were enrolled in this study from August 2011 to June 2015(excluding 246 subjects excluded from analysis). 536 and 520 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. 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).

No adverse events associated with this study were observed.

The primary endpoint of polyethylene liner wear at 5 years postoperatively was an average of -0.027 mm (SD: +/- 0.290 mm, Median: -0.027 mm) in the OX group (420 subject hips) and -0.036 mm (SD: +/- 0.283 mm, Median: -0.013 mm) in the CoCr group (407 subject hips). No statistically significant difference between the 2 groups (p = 0.6433) observed. Also, there was no significant difference in PRO (Patient report results: Harris Hip Score, Oxford Hip Score, UCLA Score) 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 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.

Nov. 30, 2022

No

TBD

https://jrct.mhlw.go.jp/latest-detail/jRCTs032180273

Akiyama Haruhiko

Gifu University Hospital

1-1 Yanagido, Gifu city, Gifu

hakiyama@gifu-u.ac.jp

Akiyama Haruhiko

Gifu University Hospital

1-1 Yanagido, Gifu city, Gifu

+81-58-230-6330

hakiyama@gifu-u.ac.jp

Complete

July. 11, 2011

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 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.

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, Oxford Hip Score, Surgical record, Adverse event

+81-45-370-7627

Jan. 11, 2019

none