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

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.

Study Overview

• Status: Unknown
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Drug: AMNIOGEN; Other: normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yi Ping Wei, MD; Phone Number: +886-7-342-2121; Email: xgoznas22@gmail.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 813
    • Recruiting
    • Yi Ping Wei
    • Contact: Yi P Wei; Phone Number: +88673422121; Email: xgoznas22@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMNIOGEN; Intraoperative1 kit of AMNIOGEN injection into shoulder joint after RCT repair.	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.
Placebo Comparator: Normal saline; Intraoperative 10 ml of normal saline injection into shoulder joint after RCT repair.	Other: normal saline; 10 ml normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
100 of participants with preoperative and postoperative physical examination are accessed by Empty can test	the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist	postoperative 1 month
100 of participants with preoperative and postoperative physical examination are accessed by Empty can test	the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist	postoperative 3 month
100 of participants with preoperative and postoperative physical examination are accessed by Empty can test	the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist	postoperative 12 month
100 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed	size and site of rotator cuff tear was accessed by MRI T1 and T2 image; MRI was checked by one orthopedist	postoperative 3 month

Collaborators and Investigators

• Sponsor: Kaohsiung Veterans General Hospital.
• Investigators: Principal Investigator: Yi Ping Wei, MD, Kaohsiung Veterans General Hospital.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2020
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: September 13, 2020
• First Submitted That Met QC Criteria: October 17, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 17, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 20-CT7-30(200527-1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No