Polydeoxyribonucleotide (PDRN) for Cuff Regeneration

NCT03916198 | Completed Phase 4 DMC

• 1 other identifier: 2019-01-021
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear

Keywords

healing; fatty degeneration; retear

Outcome Measures

Primary Outcomes (1)

• American Shoulder and Elbow score

  functional score of shoulder between 0 to 100(0: bad, 100: good)

  2 years

Secondary Outcomes (1)

• Constant score

  2 years

Study Arms (2)

PDRN(polydeoxyribonucleotide)

EXPERIMENTAL

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

Drug: Polydeoxyribonucleotides

CONTROL(normal saline)

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Polydeoxyribonucleotides DRUG

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.

Also known as: PDRN

PDRN(polydeoxyribonucleotide)

Normal saline DRUG

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.

CONTROL(normal saline)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• definite rotator cuff tear on preoperative MRI, which needs repair
• acceptance of arthroscopic surgery including rotator cuff repair

You may not qualify if:

• history of ipsilateral shoulder operation or fracture
• concomitant neurological disorder around the

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead
• Ministry of Science and ICT, Republic of Korea: collaborator

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

Location

Related Publications (3)

• Altavilla D, Squadrito F, Polito F, Irrera N, Calo 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.

  PMID: 20570301 BACKGROUND

• Galeano M, Bitto A, Altavilla D, Minutoli L, Polito F, Calo 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.

  PMID: 18318806 BACKGROUND

• 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.

  PMID: 29094396 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries; Fatty Liver

Interventions

Polydeoxyribonucleotides; Saline Solution

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Polynucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jung-Taek Hwang, MD,PhD

  Chuncheon Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 79 participants with rotator cuff tear will be randomly assigned to PDRN or CONTROL depending on the injection material. Randomization will be performed with a computerized random-sequence generator by an independent nurse.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: May 9, 2019
• Primary Completion: August 9, 2021
• Study Completion: February 22, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)