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Polydeoxyribonucleotide (PDRN) for Cuff Regeneration

NCT03916198 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2022-06-24

No results posted yet for this study

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

Interventions

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.

DRUG

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.

Sponsors & Collaborators

  • Ministry of Science and ICT, Republic of Korea

    collaborator OTHER_GOV

  • Chuncheon Sacred Heart Hospital

    lead OTHER

Principal Investigators

  • Jung-Taek Hwang, MD,PhD · Chuncheon Sacred Heart Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-09
Primary Completion
2021-08-09
Completion
2022-02-22

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03916198 on ClinicalTrials.gov