Polydeoxyribonucleotide (PDRN) for Cuff Regeneration

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03916198
Study type	Interventional
Source	Chuncheon Sacred Heart Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	May 9, 2019
Completion date	February 22, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03663036` - Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis	N/A
Withdrawn	`NCT03319784` - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients	Phase 4
Suspended	`NCT03290196` - The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics	Phase 4
Active, not recruiting	`NCT03091075` - Oxandrolone Rotator Cuff Trial	N/A
Completed	`NCT03380533` - Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair	Phase 2/Phase 3
Completed	`NCT04566939` - A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine
Active, not recruiting	`NCT02716441` - Rotator Cuff Failure With Continuity
Completed	`NCT03540030` - Opioid-Free Shoulder Arthroplasty	Phase 4
Completed	`NCT02298023` - Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)	Phase 2
Completed	`NCT01383239` - Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs	N/A
Completed	`NCT02850211` - A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair	Phase 4
Completed	`NCT01459536` - Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear	N/A
Terminated	`NCT00936559` - Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair	Phase 1
Completed	`NCT01204606` - Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)	N/A
Completed	`NCT01170312` - Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation	N/A
Completed	`NCT00852657` - Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff	N/A
Active, not recruiting	`NCT00182299` - An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS	Phase 4
Recruiting	`NCT06120998` - Quality of Life After Arthroscopic Rotator Cuff Repair
Completed	`NCT05897866` - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM)	N/A
Completed	`NCT02644564` - Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries	N/A