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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
79
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.
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.
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, South Korea
American Shoulder and Elbow score
functional score of shoulder between 0 to 100(0: bad, 100: good)
Time frame: 2 years
Constant score
functional score of shoulder between 0 to 100(0: bad, 100: good)
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.