NCT04599673

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kaohsiung Veterans General Hospital. · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
DRUG	AMNIOGEN	AmnioGen® amnion matrix allograft is a bioactive tissue matrix processed from 100% human amniotic tissue. The allograft is processed with advanced technology so the graft can be suspended in liquids and applied through needles and syringes. Amniotic tissue is composed of structural extracellular matrix, which is rich in various types of collagen, growth factors, cytokines, and specialized proteins. Thus, the application of amniotic tissue is known to modulate localized tissue inflammation, reduce scar tissue formation and promote the healing of soft tissue.
OTHER	normal saline	10 ml normal saline

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-09-30
• Completion: 2022-09-30
• First posted: 2020-10-23
• Last updated: 2020-10-23

Locations

1 site across 1 country: Taiwan