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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035425
Receipt No. R000040221
Scientific Title Comparizon of the clinical results using two different suture technique during arthroscopic Bankart repair.
Date of disclosure of the study information 2019/01/05
Last modified on 2019/01/02

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

Public contact
1st name of contact person
1st name
Middle name
Last name Tomohiko Minamikawa
Organization Fukuoka University Chikushi Hospital
Division name Dept. of Orthop. Surg.
Zip code
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
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
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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 12 Day
Last follow-up date
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 01 Month 02 Day


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

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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