Polydeoxyribonucleotide (PDRN) for Cuff Regeneration

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Polydeoxyribonucleotide (PDRN) on Healing and Fatty Degeneration of Rotator Cuff in Human

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Drug: Polydeoxyribonucleotides
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: definite rotator cuff tear on preoperative MRI, which needs repair acceptance of arthroscopic surgery including rotator cuff repair Exclusion Criteria: history of ipsilateral shoulder operation or fracture concomitant neurological disorder around the

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDRN(polydeoxyribonucleotide)<br>polydeoxyribonucleotide 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance | Drug: Polydeoxyribonucleotides<br>* 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.<br>* Other names: PDRN;|
| Placebo Comparator: CONTROL(normal saline)<br>normal saline 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance | Drug: Normal saline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow score | functional score of shoulder between 0 to 100(0: bad, 100: good) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant score | functional score of shoulder between 0 to 100(0: bad, 100: good) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healing, fatty degeneration, retear