Polydeoxyribonucleotide (PDRN) for Cuff Regeneration

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916198
• Other study ID #: 2019-01-021
• Status: Completed
• Phase: Phase 4
• Start date: May 9, 2019
• Est. completion date: February 22, 2022

Study information

• Verified date: June 2022
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: February 22, 2022
• Est. primary completion date: August 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Drug:
• Polydeoxyribonucleotides
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.
• Normal saline
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.

Locations

Country	Name	City	State
Korea, Republic of	Chuncheon Sacred Heart Hospital	Chuncheon	Gangwon-do

Sponsors (2)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital	Ministry of Science and ICT

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Altavilla D, Squadrito F, Polito F, Irrera N, Calò 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. — View Citation

Galeano M, Bitto A, Altavilla D, Minutoli L, Polito F, Calò 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Shoulder and Elbow score	functional score of shoulder between 0 to 100(0: bad, 100: good)	2 years
Secondary	Constant score	functional score of shoulder between 0 to 100(0: bad, 100: good)	2 years