UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026984