UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043715 |
|---|---|
| Receipt number | R000049769 |
| Scientific Title | Multicenter clinical study to assess the effectiveness and safety of Trident II in total hip arthroplasty (THA) |
| Date of disclosure of the study information | 2021/03/23 |
| Last modified on | 2024/03/25 09:09:06 |
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Basic information
Public title
Multicenter clinical study to assess the effectiveness and safety of Trident II in total hip arthroplasty (THA)
Acronym
Trident II multi-center study
Scientific Title
Multicenter clinical study to assess the effectiveness and safety of Trident II in total hip arthroplasty (THA)
Scientific Title:Acronym
Trident II multi-center study
Region
| Japan |
Condition
Condition
Osteoarthritis, Femoral head necrosis, Rheumatoid arthritis, fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to collect clinical outcomes and patient information after THA using Trident II and to evaluate its safety and effectiveness based on clinical data obtained in Normal medical care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effectiveness:
To evaluate the fixability and stability by radiographic evaluations (Radiolucent line, Spot welds, Bone ingrowth, Early fixation)
Key secondary outcomes
Effectiveness:
Clinical outcome(JHEQ,JOA score)
Dislocation/Revision rate
Safety
Safety information (Adverse event, Malfunction)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects enrolled prospectively
1. Patient is a candidate for primary THA with Trident II, or underwent primary THA with Trident II.
2. Patient is diagnosed with
Osteoarthritis, Femoral head necrosis, Rheumatoid arthritis, Rapidly Destructive Coxarthropathy, Fracture.
3.Patient is 20 years of age or older at the time of surgery.
4. Patient has signed an Informed
Patient Consent Form.
Subjects enrolled retrospectively
1. Patient underwent primary THA with Trident II.
2. Patient is diagnosed with
Osteoarthritis, Femoral head necrosis, Rheumatoid arthritis, Rapidly Destructive Coxarthropathy, Fracture.
3.Patient is 20 years of age or older at the time of surgery.
4. It is unable to obtain consent from the study candidate for reasons such as difficulty in visiting the hospital for follow-up, and the patient did not refuse to participate in the study by opting out by herself/himself or their alternates.
Key exclusion criteria
Subjects enrolled prospectively
1.Revision THA
2.Patient is pregnant or potentially pregnant.
3. Patient is immunologically suppressed or receiving steroids which limits the ability to evaluate radiography on this study.
4. Patient is determined to be unsuitable for other obvious reasons by the investigator.
5.Patient have participated in another clinical trial, clinical study with intervention or clinical study sponsored by other pharmaceutical/medical device companies, or plans to participate them.
Subjects enrolled retrospectively
1.Revision THA
2.Patient is pregnant or potentially pregnant.
3. Patient is immunologically suppressed or receiving steroids which limits the ability to evaluate radiography on this study.
4. Patient have participated in another clinical trial, a clinical study with intervention or a clinical study sponsored by other health care companies during the period to collect the data for this study.
5. Normal medical information is available up to immediately after surgery.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Sakai |
Organization
Yamaguchi University Hospital
Division name
Orthopedics
Zip code
755-8505
Address
1-1-1,Minami-Kogushi,Ube City,Yamaguchi
TEL
0836-22-2111
y-ortho@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Suzuki |
Organization
Stryker Japan K.K.
Division name
Clinical Affairs
Zip code
112-0004
Address
2-6-1, Koraku, Bunkyo-ku, Tokyo
TEL
03-6894-8394
Homepage URL
NSKclinicaltrial@stryker.com
Sponsor or person
Institute
Stryker Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
Stryker Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1,Minami-Kogushi,Ube City,Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-u.ac.jp
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
愛媛大学医学部附属病院（愛媛県）、大阪公立大学医学部附属病院（大阪府）、金沢大学附属病院（石川県）、東京医科歯科大学病院（東京都）、山口大学医学部附属病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 23 | 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
191
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter,Observational Study
Management information
Registered date
| 2021 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049769
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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