Polydeoxyribonucleotide (PDRN) for Cuff Regeneration

Phase 4

Completed

• Conditions: Rotator Cuff Tear
• Interventions: Drug: Normal saline; Drug: Polydeoxyribonucleotides

• Registration Number: NCT03916198
• Lead Sponsor: Chuncheon Sacred Heart Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Study Start: 2019-05-09
• Primary Completion: 2021-08-09
• Study Completion: 2022-02-22
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-18
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL(normal saline)	Normal saline	normal saline 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance
PDRN(polydeoxyribonucleotide)	Polydeoxyribonucleotides	polydeoxyribonucleotide 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow score	2 years	functional score of shoulder between 0 to 100(0: bad, 100: good)

Secondary Outcome Measures

Name	Time	Method
Constant score	2 years	functional score of shoulder between 0 to 100(0: bad, 100: good)

Trial Locations

Locations (1)

Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Gangwon-do, Korea, Republic of