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

Primary Purpose

Rotator Cuff Tears

Status

Unknown status

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

AMNIOGEN

normal saline

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Yi Ping WeiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AMNIOGEN

Normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04599673

First Posted

September 13, 2020

Last Updated

October 17, 2020

Sponsor

Kaohsiung Veterans General Hospital.

1. Study Identification

Unique Protocol Identification Number

NCT04599673

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 15, 2020 (Anticipated)

Primary Completion Date

September 30, 2021 (Anticipated)

Study Completion Date

September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kaohsiung Veterans General Hospital.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tears

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AMNIOGEN

Arm Type

Experimental

Arm Description

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

Arm Title

Normal saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AMNIOGEN

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

normal saline

Intervention Description

10 ml normal saline

Primary Outcome Measure Information:

Title

100 of participants with preoperative and postoperative physical examination are accessed by Empty can test

Description

the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist

Time Frame

postoperative 1 month

Title

100 of participants with preoperative and postoperative physical examination are accessed by Empty can test

Description

the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist

Time Frame

postoperative 3 month

Title

100 of participants with preoperative and postoperative physical examination are accessed by Empty can test

Description

the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist

Time Frame

postoperative 12 month

Title

100 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed

Description

size and site of rotator cuff tear was accessed by MRI T1 and T2 image; MRI was checked by one orthopedist

Time Frame

postoperative 3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yi Ping Wei, MD

Phone

+886-7-342-2121

xgoznas22@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi Ping Wei, MD

Organizational Affiliation

Kaohsiung Veterans General Hospital.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yi Ping Wei

City

Kaohsiung

ZIP/Postal Code

813

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi P Wei

Phone

+88673422121

xgoznas22@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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