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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023457
Receipt No. R000026984
Scientific Title A prospective study on reliability and precision of Stryker ADAPT system
Date of disclosure of the study information 2016/08/15
Last modified on 2017/05/31

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Basic information
Public title A prospective study on reliability and precision of Stryker ADAPT system
Acronym ADAPT
Scientific Title A prospective study on reliability and precision of Stryker ADAPT system
Scientific Title:Acronym ADAPT
Region
Japan

Condition
Condition Proximal femoral fractures
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of Stryker ADAPT system for proximal femoral fratcute treatment with Gamma 3 locking nail system
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Reliablity of Stryker ADAPT System
Key secondary outcomes

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 1) Patients who receive the procedure with gamma 3 locking nail system and Stryker ADAPT system due to femoral proximal fracture.
2) Patients aged 20 years and older.
3) Patients who agree on study specific Informed Consent Form
4) Patients are willing and able to comply with postoperative scheduled evaluations
Key exclusion criteria 1) Female subjects who are pregnant.
2) Patients who diagnosed as systemic disease or metabolic disease.
3) Patients who are immunological disease or received excess steroid(>30days).
4) Patients who have active/latent infection.
5) Patients who are judged ineligible with reasonable reason by investigators.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoki Takahashi
Organization Medical corporation juryo of Kumamoto kinoh hospital
Division name Orthopaedics
Zip code
Address 6-8-1, Yamamuro, Kita-ku, Kumamoto-shi, Kumamoto
TEL 096-345-8111
Email takahashitomoki@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Motohashi
Organization Stryker Japan K.K.
Division name Clinical Affairs
Zip code
Address 2-6-1, Koraku, Bunkyo-ku, Tokyo
TEL 03-6894-8219
Homepage URL
Email satoru.motohashi@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
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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 15 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
2016 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate reliablity of Stryker ADAPT system by comparing TSD of the sytem with the one caliculated based on post-op CT

Management information
Registered date
2016 Year 08 Month 03 Day
Last modified on
2017 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026984

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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