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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006013
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Zimmer K.K
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007117

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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