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| Name | Class |
|---|---|
| Ministry of Science and ICT, Republic of Korea | OTHER_GOV |
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This study is to evaluate the effect of polydeoxyribonucleotide (PDRN) for healing and fatty degeneration of rotator cuff. The investigators will enroll 130 patients with rotator cuff tear who will undergo arthroscopic rotator cuff repair. 130 patients will be classified into two group. One group (PDRN) will be injected at the repaired cuff with 3cc polydeoxyribonucleotide just after surgery and be injected with another 3ml polydeoxyribonucleotide under ultrasound guidance 2 weeks after the surgery. The other group (CONTROL) will be injected with 3ml normal saline in the same manner.
Polydeoxyribonucleotide is a tissue regeneration activator. It binds an adenosine receptor and stimulate VEGF(vascular endothelial growth factor) synthesis and stimulate collagen synthesis. Nowadays, a lot of arthroscopic rotator cuff repairs are being performed. but the failure rate of rotator cuff repair is considerably high. Therefore, this study is to evaluate the effect of polydeoxyribonucleotide for healing and fatty degeneration of rotator cuff.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDRN(polydeoxyribonucleotide) | Experimental | polydeoxyribonucleotide 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance |
|
| CONTROL(normal saline) | Placebo Comparator | normal saline 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polydeoxyribonucleotides | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder and Elbow score | functional score of shoulder between 0 to 100(0: bad, 100: good) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Constant score | functional score of shoulder between 0 to 100(0: bad, 100: good) | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung-Taek Hwang, MD,PhD | Chuncheon Sacred Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chuncheon Sacred Heart Hospital | Chuncheon | Gangwon-do | 24253 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20570301 | Background | 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. | |
| 18318806 |
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There is a privacy problem. The investigators should negotiate with our government about that.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2019 | Apr 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D011089 | Polydeoxyribonucleotides |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011119 | Polynucleotides |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000077324 | Crystalloid Solutions |
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79 participants with rotator cuff tear will be classified into two group. One group (PDRN) will be injected at the repaired cuff with 3cc polydeoxyribonucleotide just after surgery and be injected with another 3cc polydeoxyribonucleotide under ultrasound guidance 2 weeks after the surgery. The other group (CONTROL) will be injected with 3ml normal saline in the same manner.
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79 participants with rotator cuff tear will be randomly assigned to PDRN or CONTROL depending on the injection material. Randomization will be performed with a computerized random-sequence generator by an independent nurse.
|
| Normal saline | Drug | 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. |
|
| 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. |
| 29094396 | Result | 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. |
| D008107 |
| Liver Diseases |
| D004066 | Digestive System Diseases |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |