Polydeoxyribonucleotide (PDRN) for Cuff Regeneration

Chuncheon Sacred Heart Hospital

Status and phase: Completed; Phase 4

Conditions: Rotator Cuff Tear

Treatments: Drug: Normal saline; Drug: Polydeoxyribonucleotides

Study type: Interventional

Funder types: Other

Identifiers

NCT03916198

2019-01-021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 79 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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79 participants in 2 patient groups, including a placebo group

PDRN(polydeoxyribonucleotide)

Experimental group

Description:

polydeoxyribonucleotide 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance

Treatment:

Drug: Polydeoxyribonucleotides

CONTROL(normal saline)

Placebo Comparator group

Description:

normal saline 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance

Treatment:

Drug: Normal saline