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

Kaohsiung Veterans General Hospital

Status and phase: Unknown; Phase 4

Conditions: Rotator Cuff Tears

Treatments: Other: normal saline; Drug: AMNIOGEN

Study type: Interventional

Funder types: Other

Identifiers

NCT04599673

20-CT7-30(200527-1)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

AMNIOGEN

Experimental group

Description:

Intraoperative1 kit of AMNIOGEN injection into shoulder joint after RCT repair.

Treatment:

Drug: AMNIOGEN

Normal saline

Placebo Comparator group

Description:

Intraoperative 10 ml of normal saline injection into shoulder joint after RCT repair.

Treatment:

Other: normal saline