UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014758 |
|---|---|
| Receipt number | 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 11:47:50 |
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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
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
seikeigeka@fc.kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017155
