UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031714 |
|---|---|
| Receipt number | R000036223 |
| Scientific Title | Efficacy of bone marrow stimulation in arthroscopic rotator cuff repair |
| Date of disclosure of the study information | 2018/03/15 |
| Last modified on | 2023/03/18 10:01:22 |
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Basic information
Public title
Efficacy of bone marrow stimulation in arthroscopic rotator cuff repair
Acronym
Efficacy of bone marrow stimulation in arthroscopic rotator cuff repair
Scientific Title
Efficacy of bone marrow stimulation in arthroscopic rotator cuff repair
Scientific Title:Acronym
Efficacy of bone marrow stimulation in arthroscopic rotator cuff repair
Region
| Japan |
Condition
Condition
rotator cuff tear
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to compare the clinical outcomes and structual integrity of arthroscopic rotator cuff repairs with and without bone marrow stimulation. This was a prospective randomized study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tendon heeling was assessed 6-, 12-,24-months after the operation on magnetic resonance images
Key secondary outcomes
Functional evaluation of the shoulder was performed with the JOA score, UCLA score and Constant-Murley shoulder outcome score and self-reporting scale(Simple Shoulder test) .The scores obtained preoperative and 6-, 12-,24-months after the operation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
arthroscopic rotator cuff repair with bone marrow stimulation
Interventions/Control_2
arthroscopic rotator cuff repair without bone marrow stimulation
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
Patients with full-thickness rotator cuff tears undergoing primary arthroscopic rotator cuff repair
Reparable rotator cuff tears under arthroscopic surgery.
Key exclusion criteria
History of shoulder fracture or dislocation and prior surgery to the affected shoulder.
Inflammatory or neurologic disease.
Irreparable rotator cuff tears under arthroscopic surgery.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Terufumi |
| Middle name | |
| Last name | Shibata |
Organization
Fukuoka University Faculty of Medicine
Division name
Dept.of Orthop.Surg
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
TEL
092-801-1011
teru-sky-ideal@lion.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Terufumi |
| Middle name | |
| Last name | Shibata |
Organization
Fukuoka University Faculty of Medicine
Division name
Dept.of Orthop.Surg
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
TEL
092-801-1011
Homepage URL
teru-sky-ideal@lion.ocn.ne.jp
Sponsor or person
Institute
Fukuoka University Faculty of Medicine
Dept.of Orthop.Surg
Institute
Department
Personal name
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 Univ. Clinical Research & Ethics Centre
Address
7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
Tel
092-801-1011
fumed-ethics@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
| 2018 | Year | 03 | 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
| 2017 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 05 | 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
| 2018 | Year | 03 | Month | 14 | Day |
Last modified on
| 2023 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036223
