UMIN-CTR Clinical Trial

Basic information
Public title	Comparizon of the clinical results using two different suture technique during arthroscopic Bankart repair.
Acronym	Clinical results of arthroscopic Bankart repair
Scientific Title	Comparizon of the clinical results using two different suture technique during arthroscopic Bankart repair.
Scientific Title:Acronym	Clinical results of arthroscopic Bankart repair
Region	Japan

Condition
Condition	recurrent anterior shoulder instability
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to compare the clinical results using two different suture technique during arthroscopic Bankart repair.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of postoperative recurrent instability.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The patients who undergo arthroscopic Bankart repair with traditional protocol using simple suture.
Interventions/Control_2	The patients who undergo arthroscopic Bankart repair with new protocol using mattress suture.
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. The patients who visited to our hospital 15 years or older 2. The patients who were diagnosed with posttraumatic anterior shoulder instability 3. The patients who had Bankart lesion on MR imaging. 4. The patients who are planned to undergo arthroscopic Bankart repair. 5. The patients who obtained the consent in this study. 6. The patients of minor who can be obtained informed consent by their guardians.
Key exclusion criteria	1. The patients who had significant glenoid bone loss (glenoid deficit > 20%) 2. The patients who had capsular tear or humeral avulsion of the glenohumeral ligament lesion. 3. The patients who had large Hill-Sachs lesion over the glenoid track. 4. The patients who had a surgical history of the shoulder. 5. contact / collision sport athletes. 6. Extrinsic disease (neuromuscular disease, congenital malformation etc) 7. Patients who was not obtained the consent in this study. 8. The patient who cannot understand the postoperative programs because of mental disorders (dementia etc)
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Tomohiko Middle name Last name Minamikawa
Organization	Fukuoka University Chikushi Hospital
Division name	Dept. of Orthop. Surg.
Zip code	818-8502
Address	1-1-1, Zokumyoin, Chikushino, Fukuoka
TEL	092-921-1011
Email	tomominamikawa@yahoo.co.jp

Public contact
Name of contact person	1st name Tomohiko Middle name Last name Minamikawa
Organization	Fukuoka University Chikushi Hospital
Division name	Dept. of Orthop. Surg.
Zip code	818-8502
Address	1-1-1, Zokumyoin, Chikushino, Fukuoka
TEL	092-921-1011
Homepage URL
Email	tomominamikawa@yahoo.co.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukuoka University Chikushi Hospital
Address	1-1-1, Zokumyoin, Chikushino, Fukuoka
Tel	092-921-1011
Email	chikushirinsho@adm.fukuoka-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

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 05 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	Open public recruiting
Date of protocol fixation	2019 Year 01 Month 05 Day
Date of IRB	2019 Year 01 Month 24 Day
Anticipated trial start date	2019 Year 01 Month 12 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 02 Day
Last modified on	2019 Year 11 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040221