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Completed

NCT Number: NCT03916198

Polydeoxyribonucleotide (PDRN) for Cuff Regeneration

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.

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Key information

Conditions

Rotator Cuff Tear Digestive System Diseases Fatty Liver Liver Diseases Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PDRN

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.

Primary outcomes

  1. American Shoulder and Elbow score

    Time frame: 2 years

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

Secondary outcomes

  1. Constant score

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Collaborators

  • Ministry of Science and ICT, Republic of Korea

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 16, 2019
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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