UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023457 |
|---|---|
| Receipt number | 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 | 2020/02/05 11:34:17 |
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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
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
satoru.motohashi@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
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
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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 21 | Day |
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
| 2020 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026984
