NCT05603468

Effect of PRP vs Corticosteroid in Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair

Effect of Platelet-Rich Plasma vs Corticosteroid Injection in Distinct Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair: a Multicenter, Three-group, Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 387 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multicenter, randomized, single-blinded, parallel group，placebo-controlled，three-group establishment of specific treatment regimen for subtypes of tendinopathy

Detailed description

This clinical trial uses machine learning to match molecular and clinical features，so as to establish a "rapid recognition system of tendinopathy subtypes" and compares the clinical effects of corticosteroid，platelet rich plasma or placebo on different subtypes of tendinopathy.

Conditions

• Tendinopathy

Interventions

Type	Name	Description
DRUG	platelet rich plasma	Platelet rich plasma group: after the surgery of rotator arthroscopic rotator cuff repair, 3ml PRP (LongTai Biological Company) was injected into the rotator cuff tear under the rotator arthroscope for a time. PRP production process: before anesthesia, 20ml arterial blood was drawn and injected into the PRP tube. The blood was fully oscillated in the tube, and then placed in a centrifuge with 1500g for 9min to remove excess plasma and make 5ml PRP. 3ml is used for injection and 2ml is used for quality control.
DRUG	Corticosteroid	Corticosteroid group: after the surgery of rotator cuff repair under arthroscopy, 1mL prednisone (MSD) + 2mL sodium hyaluronate (biochemical Industry Co., Ltd.) was injected under arthroscopy.
DRUG	Normal saline	Normal saline

Timeline

• Start date: 2022-12-15
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2022-11-02
• Last updated: 2026-02-09

Locations

1 site across 1 country: China