---
title: Polydeoxyribonucleotide (PDRN) for Cuff Regeneration
nct_id: NCT03916198
overall_status: COMPLETED
phase: PHASE4
sponsor: Chuncheon Sacred Heart Hospital
study_type: INTERVENTIONAL
primary_condition: Rotator Cuff Tear
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03916198.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03916198"
ct_last_update_post_date: 2022-06-24
last_seen_at: "2026-05-12T06:37:30.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Polydeoxyribonucleotide (PDRN) for Cuff Regeneration

**Official Title:** Effect of Polydeoxyribonucleotide (PDRN) on Healing and Fatty Degeneration of Rotator Cuff in Human

**NCT ID:** [NCT03916198](https://clinicaltrials.gov/study/NCT03916198)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 79
- **Lead Sponsor:** Chuncheon Sacred Heart Hospital
- **Collaborators:** Ministry of Science and ICT, Republic of Korea
- **Conditions:** Rotator Cuff Tear
- **Start Date:** 2019-05-09
- **Completion Date:** 2022-02-22
- **CT.gov Last Update:** 2022-06-24

## 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.

## Eligibility

- **Minimum age:** 20 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **PDRN(polydeoxyribonucleotide)** (EXPERIMENTAL) — polydeoxyribonucleotide 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance
- **CONTROL(normal saline)** (PLACEBO_COMPARATOR) — normal saline 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance

## 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.
- **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

- **American Shoulder and Elbow score** _(time frame: 2 years)_ — functional score of shoulder between 0 to 100(0: bad, 100: good)

## Secondary Outcomes

- **Constant score** _(time frame: 2 years)_

## Locations (1)

- Chuncheon Sacred Heart Hospital, Chuncheon, Gangwon-do, South Korea

## Recent Field Changes (last 30 days)

- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.chuncheon sacred heart hospital|chuncheon|gangwon-do|south korea` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03916198.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03916198*  
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