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

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ClinicalTrials.gov Identifier: NCT04599673
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Yi Ping Wei, Kaohsiung Veterans General Hospital.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Rotator Cuff Tears Drug: AMNIOGEN Other: normal saline Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Analysis of Intraoperative AMNIOGEN® Injection in Patients With Rotator Cuff Tear
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 100 of participants with preoperative and postoperative physical examination are accessed by Empty can test [ Time Frame: postoperative 1 month ]
    the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist

  2. 100 of participants with preoperative and postoperative physical examination are accessed by Empty can test [ Time Frame: postoperative 3 month ]
    the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist

  3. 100 of participants with preoperative and postoperative physical examination are accessed by Empty can test [ Time Frame: postoperative 12 month ]
    the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist

  4. 100 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed [ Time Frame: postoperative 3 month ]
    size and site of rotator cuff tear was accessed by MRI T1 and T2 image; MRI was checked by one orthopedist


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04599673


Contacts
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Contact: Yi Ping Wei, MD +886-7-342-2121 xgoznas22@gmail.com

Locations
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Taiwan
Yi Ping Wei Recruiting
Kaohsiung, Taiwan, 813
Contact: Yi P Wei    +88673422121    xgoznas22@gmail.com   
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
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Principal Investigator: Yi Ping Wei, MD Kaohsiung Veterans General Hospital.
More Information
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Responsible Party: Yi Ping Wei, Orthopaedic, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT04599673    
Other Study ID Numbers: 20-CT7-30(200527-1)
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries