UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002949 |
|---|---|
| Receipt number | R000003587 |
| Scientific Title | General clinical study of acetabular cup (TM Cup) for total hip arthroplasty |
| Date of disclosure of the study information | 2010/05/31 |
| Last modified on | 2010/04/27 17:22:56 |
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Basic information
Public title
General clinical study of acetabular cup (TM Cup) for total hip arthroplasty
Acronym
General clinical study of acetabular cup (TM Cup) for total hip arthroplasty
Scientific Title
General clinical study of acetabular cup (TM Cup) for total hip arthroplasty
Scientific Title:Acronym
General clinical study of acetabular cup (TM Cup) for total hip arthroplasty
Region
| Japan |
Condition
Condition
Patients with hip pain and dysfunction who have been diagnosed to require hip replacement.
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of TM Cup in THA and to determine its usefulness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
(1) Efficacy evaluation based on the evaluations of the X-ray images (radiolucent zones) and JOA score at postoperative 12 months.
(2) Safety evaluation
Adverse events up to postoperative 12 months.
(3) Usefulness evaluation according to the matrix of efficacy and safety results.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Implantation of TM Cup by THA.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) A patient with hip pain and dysfunction who has been diagnosed to require THA and to be indicated for a cementless fixation at the acetabular side.
(2) A patient who understands the purpose of this clinical study and has provided a written consent.
(3) A patient who may be followed up for 12 months postoperatively.
Key exclusion criteria
(1)A patient with a previous history of infection in the affected joint.
(2)A patient with an immature bone structure.
(3)A patient with neuropathic arthropathy.
(4)A patient with infection-like symptoms.
(5)A patient with rheumatoid arthritis with a previous history of skin ulcer or recurrent skin breakdown.
(6)A patient with osteoporosis or neuromuscular disease that may compromise the affected limbs.
(7)A patient with severely unstable hip joint due to a decreased muscular or ligamentous support.
(8)A patient who has been judged ineligible for the conduct of the study by the study investigator.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihide Iwamoto, MD |
Organization
Kyusyu University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Zimmer K.K.
Division name
Clinical Affairs
Zip code
Address
4-1-17 Toranomon, Minato-ku, Tokyo
TEL
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
2003年7月17日 （届出回数:10回）
Institutions
Institutions
九州大学病院（福岡県）、琉球大学医学部附属病院（沖縄県）、愛媛大学医学部附属病院（愛媛県）、横浜市立大学医学部附属市民総合医療センター(神奈川県)/ Kyusyu University Hospital (Fukuoka), Ryukyu University Medical School Affiliated Hospital (Okinawa), Ehime University Medical School Affiliated Hospital (Ehime), Yokohama City University Medical School Affiliated Municipal General Medical Center (Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | 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
| 2003 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 28 | Day |
Last modified on
| 2010 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003587
