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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005316
Receipt No. 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

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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
Email 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
Email akira.kashima@zimmerbiomet.com

Sponsor
Institute Zimmer Biomet G.K.
Institute
Department

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
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 - 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
URL(English) https://upload.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


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