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

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Veterans General Hospital.

Criteria

Inclusion Criteria:

• receiving unilateral shoulder RCT repair in our hospital postoperative follow-up over 3 month

Exclusion Criteria:

• postoperative follow-up less than 3 month possible pregnency with coagulation disease NSAIDs intake during study period