UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006013 |
|---|---|
| Receipt number | R000007117 |
| Scientific Title | Clinical study on wear resistance of highly cross-linked polyethylene (Longevity) |
| Date of disclosure of the study information | 2011/07/31 |
| Last modified on | 2011/07/20 18:14:33 |
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Basic information
Public title
Clinical study on wear resistance of highly cross-linked polyethylene (Longevity)
Acronym
Longevity study
Scientific Title
Clinical study on wear resistance of highly cross-linked polyethylene (Longevity)
Scientific Title:Acronym
Longevity study
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the wear resistance of the cross-linked polyethylene liner (Longevity) used for total hip arthroplasty with that of the standard polyethylene liner (Trilogy poly-liner) and also to compare clinical evaluation of both liners
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the wear resistance of the polyethylene liner
Key secondary outcomes
JOA score, SF-12
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent total hip arthroplasty using either Longevity or Trilogy poly-liner between October 2000 and May 2003.
Patients who fulfilled the following inclusion criteria at the time of total hip arthroplasty:
-Primary disease: hip osteoarthritis
-Age: 70 years or younger
-Patients with stable health conditions based on the physical examination and medical history
Key exclusion criteria
Patients who did not violate any of the following exclusion criteria at the time of total hip arthroplasty:
-Patients with a history of infection at the affected joint
-Patients with immature skeleton
-Patients with a history of total hip arthroplasty at the affected joint (cases of revision)
-Patients with a history of alcohol or drug addiction, for whom poor compliance is expected
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohiko Mashima |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Bone and Joint Surgery
Zip code
Address
Shizukawa, Toon, Ehime Japan
TEL
089-960-5343
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Zimmer K.K
Division name
Clinical Affairs
Zip code
Address
1-17, Prime place, Toranomon 4-chome Minato-ku, Tokyo, Japan
TEL
03-6402-6752
Homepage URL
Sponsor or person
Institute
Zimmer K.K
Institute
Department
Personal name
Funding Source
Organization
Zimmer K.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
日産厚生会玉川病院(東京都)、医療法人沖縄徳洲会湘南鎌倉人工関節センター(神奈川県)、大阪市立大学医学部附属病院(大阪府)、愛媛大学医学部附属病院(愛媛県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Multi-center, Prospective Clinical Study
Management information
Registered date
| 2011 | Year | 07 | Month | 20 | Day |
Last modified on
| 2011 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007117
