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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043715
Receipt No. 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 2021/09/30

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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
Email 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
Email NSKclinicaltrial@stryker.com

Sponsor
Institute Stryker Japan K.K.
Institute
Department

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
Email 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)、大阪市立大学医学部附属病院(大阪府)、金沢大学附属病院(石川県)、東京医科歯科大学医学部附属病院(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
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 Enrolling by invitation
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
2021 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049769

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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