Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
79 participants
INTERVENTIONAL
2019-05-09
2022-02-22
Brief Summary
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Detailed Description
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Visual analog scale (VAS) of pain and other functional scores of the two group will be checked preoperatively and postoperative 3, 6, 12, 24 months. Growth factors (VEGF, fibroblast growth factor(FGF), insulin like growth factor(IGF)) will be checked preoperatively and postoperative 1h, 2 days, 2 weeks, 6 weeks, 3, 6 months. Follow up MRI will be checked at postoperative 6 months. The parameters will be compared using statistical analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PDRN(polydeoxyribonucleotide)
polydeoxyribonucleotide 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance
Polydeoxyribonucleotides
Just after arthroscopic rotator cuff repair, 3cc polydeoxyribonucleotide will be injected, and 2 weeks after the surgery the same amount of the material will be injected.
CONTROL(normal saline)
normal saline 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance
Normal saline
Just after arthroscopic rotator cuff repair, 3cc normal saline will be injected, and 2 weeks after the surgery the same amount of the material will be injected.
Interventions
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Polydeoxyribonucleotides
Just after arthroscopic rotator cuff repair, 3cc polydeoxyribonucleotide will be injected, and 2 weeks after the surgery the same amount of the material will be injected.
Normal saline
Just after arthroscopic rotator cuff repair, 3cc normal saline will be injected, and 2 weeks after the surgery the same amount of the material will be injected.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* acceptance of arthroscopic surgery including rotator cuff repair
Exclusion Criteria
* concomitant neurological disorder around the
20 Years
ALL
No
Sponsors
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Ministry of Science and ICT, Republic of Korea
OTHER_GOV
Chuncheon Sacred Heart Hospital
OTHER
Responsible Party
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Jung-Taek Hwang
Associate Professor
Principal Investigators
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Jung-Taek Hwang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Chuncheon Sacred Heart Hospital
Locations
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Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, South Korea
Countries
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References
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Altavilla D, Squadrito F, Polito F, Irrera N, Calo M, Lo Cascio P, Galeano M, La Cava L, Minutoli L, Marini H, Bitto A. Activation of adenosine A2A receptors restores the altered cell-cycle machinery during impaired wound healing in genetically diabetic mice. Surgery. 2011 Feb;149(2):253-61. doi: 10.1016/j.surg.2010.04.024. Epub 2010 Jun 8.
Galeano M, Bitto A, Altavilla D, Minutoli L, Polito F, Calo M, Lo Cascio P, Stagno d'Alcontres F, Squadrito F. Polydeoxyribonucleotide stimulates angiogenesis and wound healing in the genetically diabetic mouse. Wound Repair Regen. 2008 Mar-Apr;16(2):208-17. doi: 10.1111/j.1524-475X.2008.00361.x.
Kang SH, Choi MS, Kim HK, Kim WS, Bae TH, Kim MK, Chang SH. Polydeoxyribonucleotide improves tendon healing following achilles tendon injury in rats. J Orthop Res. 2018 Jun;36(6):1767-1776. doi: 10.1002/jor.23796. Epub 2017 Nov 28.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019-01-021
Identifier Type: -
Identifier Source: org_study_id
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