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

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04599673
• Other study ID #: 20-CT7-30(200527-1)
• Status: Recruiting
• Phase: Phase 4
• Start date: October 15, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2020
• Source: Kaohsiung Veterans General Hospital.
• Contact: Yi Ping Wei, MD
• Phone: +886-7-342-2121
• Email: xgoznas22[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

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

Locations

Country	Name	City	State
Taiwan	Yi Ping Wei	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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