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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014758
Receipt No. R000017155
Scientific Title The clinical outcomes and structural integrity of arthroscopic transosseous equivalent rotator cuff repair utilizing the knotless suture-bridge technique: Prospective comparative study.
Date of disclosure of the study information 2014/08/04
Last modified on 2017/08/07

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Basic information
Public title The clinical outcomes and structural integrity of arthroscopic transosseous equivalent rotator cuff repair utilizing the knotless suture-bridge technique: Prospective comparative study.
Acronym The clinical outcomes and structural integrity of arthroscopic transosseous equivalent rotator cuff repair utilizing the knotless suture-bridge technique.
Scientific Title The clinical outcomes and structural integrity of arthroscopic transosseous equivalent rotator cuff repair utilizing the knotless suture-bridge technique: Prospective comparative study.
Scientific Title:Acronym The clinical outcomes and structural integrity of arthroscopic transosseous equivalent rotator cuff repair utilizing the knotless suture-bridge technique.
Region
Japan

Condition
Condition rotator cuff tear
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the present study is to evaluate the structural integrity and clinical outcomes of arthroscopic rotator cuff repairs using the transosseous-equivalent (TOE) knotless suture bridge technique, comparing with those of conventional (single row or double row) repair, prospectively.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Clinical Assessment
Pre- and postoperative clinical assessment consisted of a structured interview, a detailed physical examination, and evaluation using University of California at Los Angeles (UCLA) and Japanese Orthopaedic Association (JOA) scores. The scores obtained before- and 3-, 6-, 12-, 18-, and 24-months after the operation and at the latest follow-up were recorded.
Key secondary outcomes Range of motion of the shoulder joint
The structural integrity of the repaired rotator cuff was evaluated on MRI scans.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 conventional single row repair
Interventions/Control_2 knotless double row suture bridge repair
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) arthroscopic repair of a full-thickness rotator cuff tear, (2) availability of pre- and post-operative magnetic resonance imaging (MRI) scans of the involved shoulder, and (3) a minimum follow-up of two years.
Key exclusion criteria (1) an irreparable rotator cuff tear
(2) a partial rotator cuff repair
(3) cuff tear arthropathy on preoperative plain radiographs and at arthroscopy
(4) stage 3- or 4 fatty infiltration of multiple rotator cuff muscles on T1-weighted MRI scans
(5) a failed prior rotator cuff repair
(6) a workers compensation claim

Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Ide
Organization Kumamoto University
Division name Advanced Joint Reconstructive Surgery
Zip code
Address 1-1-1, Honjo, Central Ward, Kumamoto City, 860-8556, Japan
TEL 096-373-5226
Email ide@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junji Ide
Organization Kumamoto University
Division name Advanced Joint Reconstructive Surgery
Zip code
Address 1-1-1, Honjo, Central Ward, Kumamoto City, 860-8556, Japan
TEL 096-373-5226
Homepage URL
Email seikeigeka@fc.kuh.kumamoto-u.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Kumamoto University
Institute
Department

Funding Source
Organization Kumamoto University
Organization
Division
Category of Funding Organization Self funding
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
2014 Year 08 Month 04 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2011 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 17 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 04 Month 30 Day
Date trial data considered complete
2018 Year 04 Month 30 Day
Date analysis concluded
2018 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 08 Month 04 Day
Last modified on
2017 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017155

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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