drugset / Trial / NCT04599673

Prospective Analysis of Intraoperative AMNIOGEN® Injection in Patients With Rotator Cuff Tear

NCT04599673 ↗

Phase 4 Unknown 100 enrolled Kaohsiung Veterans General Hospital.
RandomizedParallel-groupSingle-blindTreatment

Summary

Purpose: The purpose of this article is to examine the clinical application of AMNIOGEN® in patients with rotator cuff tear. Methods: The study was conducted on 100 adult participants with age over affected by unilateral shoulder rotator cuff tear and receiving RCT repair. The investigators divided the participants in two groups, and the group A was treated with perioperative injection of AMNIOGEN® A, group B with perioperative normal saline. Follow-up: Every 1,3,and 12months, the investigators recheck physical exmianation at OPD and recheck MRI at postoperative 3 months.

Timeline

Start
2020-10-15
Primary completion
2021-09-30
Completion
2022-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject AMNIOGEN Other / unclassified 1 unknown Other

Indications