UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007309 |
|---|---|
| Receipt number | R000008619 |
| Scientific Title | Wear of 32mm Oxidized Zirconium (OXINIUM) head on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study |
| Date of disclosure of the study information | 2012/02/16 |
| Last modified on | 2024/12/19 14:30:27 |
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Basic information
Public title
Wear of 32mm Oxidized Zirconium (OXINIUM) head on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study
Acronym
Wear of 32mm OXINIUM head on XLPE: Multicenter RCT Study
Scientific Title
Wear of 32mm Oxidized Zirconium (OXINIUM) head on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study
Scientific Title:Acronym
Wear of 32mm OXINIUM head on XLPE: Multicenter RCT Study
Region
| Japan |
Condition
Condition
Hip Disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate wear resistance of 32mm oxidized zirconium femoral head versus CoCr on cross-linked polyethylene for primary total hip arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Linear wear of polyethylene liner
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Implantation of oxidized zirconium alloy femoral head
Interventions/Control_2
Implantation of cobalt-chrome alloy femoral head
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patient whose written consent was obtained to participate in the study
2. Patient with indication for THA
3. Patient younger than 75 y.o.
4. Patient able to implant 28mm femoral head
5. Patient with UCLA score higher than 3
6. Patient who has Japanese nationality
Key exclusion criteria
1. Revision THA
2. Implantation of all-polyethylene cup
3. THA case with need to use lateralized and anteverted liner in the pre-op planning
4. Patient unable to evaluate Oxford Hip Score
5. Patient expected to live less than 5 years
Target sample size
352
Research contact person
Name of lead principal investigator
| 1st name | Shinichirou |
| Middle name | |
| Last name | Kume |
Organization
KURUME UNIVERSITY MEDICAL CENTER
Division name
Orthopaedic and Joint Surgery Center
Zip code
839-0863
Address
155-1 Kokubun-cho, Kurume, Fukuoka, Japan
TEL
0942-22-6111
skume@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichirou |
| Middle name | |
| Last name | Kume |
Organization
KURUME UNIVERSITY MEDICAL CENTER
Division name
Orthopaedic and Joint Surgery Center
Zip code
839-0863
Address
155-1 Kokubun-cho, Kurume, Fukuoka, Japan
TEL
0942-22-6111
Homepage URL
skume@med.kurume-u.ac.jp
Sponsor or person
Institute
Smith & Nephew K.K
Institute
Department
Personal name
Funding Source
Organization
Smith & Nephew K.K
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Medical Center, Nagasaki Rosai Hospital, Kochi Medical School Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Certified Institutional Review Board
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa
Tel
045-370-7627
ycu_crb@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 16 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
https://jrct.niph.go.jp/latest-detail/jRCTs032180245
Number of participants that the trial has enrolled
284
Results
The primary endpoint of polyethylene liner wear at 5 years postoperatively was an average of -0.158 mm in the OX group (77 subject hips) and - 0.149 mm in the CoCr group (71 subject hips). No statistically significant difference between the 2 groups (p = 0.9459) was observed.There was no significant difference in PRO (Patient report results: Harris Hip Score, UCLA Score, Oxford Hip Score, JOA Hip score and JHEQ Score) between the two groups.
Results date posted
| 2024 | Year | 12 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
251 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 63.2 years, 199 subject hips (79.3%) were female, and the primary diagnosis was secondary osteoarthritis in 191 (76.1%), idiopathic osteonecrosis of the femoral head in 20 (8.0%), primary osteoarthritis in 24 (9.6%), and others in 5 (2.0%).
Participant flow
Between October 2012 and March 2015, 251 patients were enrolled (excluding 33 excluded from the analysis). 125 and 126 patients were allocated to the OXINIUM femoral head (OX) and cobalt-chromium alloy femoral head (CoCr) groups, respectively, for surgery and follow-up.
Adverse events
No AE attributable to this study were noted.
Outcome measures
Primary Efficacy Variables: Evaluation of linear wear of polyethylene liner at 5 years postoperatively. Clinical success was the significant reduction of linear wear of OXINIUM against CoCr.
Secondary Efficacy Variables: To generate performance evidence supporting the use of the above total hip arthroplasty system.
Secondary Efficacy Variables:
Outcome of Harris Hip Score, UCLA Score, Oxford Hip Score, JOA Hip score and JHEQ Score.
Safety Variables:
Evaluation of all adverse events (AEs), serious adverse events
(SAEs), and complications including intraoperative AEs and complications.
Analysis of device-related intervention
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2012 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 16 | Day |
Last modified on
| 2024 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008619
