UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005316 |
|---|---|
| Receipt number | R000006316 |
| Scientific Title | A Clinical Study on the Dislocation and Wear of Highly Crosslinked Polyethylene Liner |
| Date of disclosure of the study information | 2011/03/25 |
| Last modified on | 2017/03/08 10:09:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Clinical Study on the Dislocation and Wear of Highly Crosslinked Polyethylene Liner
Acronym
26/32 Study
Scientific Title
A Clinical Study on the Dislocation and Wear of Highly Crosslinked Polyethylene Liner
Scientific Title:Acronym
26/32 Study
Region
| Japan |
Condition
Condition
Osteoarthritis of the Hip, Avascular Necrosis of the Femoral Head
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to compare the amount of liner wear and occurrence of complications such as dislocation for the different sizes of femoral heads used concomitantly with a highly crosslinked polyethylene liner in total hip arthroplasty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The mean annual wear of the polyethylene liner and the incidences of dislocation
Key secondary outcomes
X-ray findings, Harris Hip Score, JOA Score and QOL
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patients who underwent total hip arthroplasty using Longevity
Key exclusion criteria
- Patients with osteomyelitis of the upper femoral bone
- Patients with active infection at the affected joint
- Patients with extremely insufficient bone mass
- Patients who have already undergone hip replacement arthroplasty
- Patients with the socket outer diameter of less than 48 mm
- Other patients who are judged to be ineligible to participate in the study by the surgeon
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanobu Saito |
Organization
National Hospital Organization Osaka Minami Medical Center
Division name
Orthopedic Surgery
Zip code
Address
2-1 Kidohigashi-machi, Kawachi nagano, Osaka
TEL
0721-53-7010
akira.kashima@zimmerbiomet.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Kashima |
Organization
Zimmer Biomet G.K.
Division name
Clinical Affairs
Zip code
Address
15F, Sumitomo Fudosan Shibakoen Tower, 2-11-1 Shibakoen, Minato-ku, Tokyo
TEL
03-6402-6600
Homepage URL
akira.kashima@zimmerbiomet.com
Sponsor or person
Institute
Zimmer Biomet G.K.
Institute
Department
Personal name
Funding Source
Organization
Zimmer Biomet G.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
- 独立行政法人 国立病院機構 大阪南医療センター(大阪府)
- 福岡大学病院(福岡県)
- 久留米大学医療センター(福岡県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Our study suggested that whether to select 26- or 32-mm diameters of femoral head does not affect XLPE wear in combination with this type of articulation.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2002 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 05 | Month | 01 | Day |
Other
Other related information
Multi-center, Randomized Control Study
Management information
Registered date
| 2011 | Year | 03 | Month | 25 | Day |
Last modified on
| 2017 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006316
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/03/08 | Polyethylene Wear Associated With 26 and 32 mm Heads in THA - A Multicenter Prospective Study.pdf |
