Prospective Analysis of Intraoperative AMNIOGEN® Injection in Patients With Rotator Cuff Tear
NCT ID: NCT04599673
Last Updated: 2020-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2020-10-15
2022-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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AMNIOGEN
Intraoperative1 kit of AMNIOGEN injection into shoulder joint after RCT repair.
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.
Normal saline
Intraoperative 10 ml of normal saline injection into shoulder joint after RCT repair.
normal saline
10 ml normal saline
Interventions
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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.
normal saline
10 ml normal saline
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
ALL
No
Sponsors
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Kaohsiung Veterans General Hospital.
OTHER
Responsible Party
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Yi Ping Wei
Orthopaedic
Principal Investigators
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Yi Ping Wei, MD
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Veterans General Hospital.
Locations
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Yi Ping Wei
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20-CT7-30(200527-1)
Identifier Type: -
Identifier Source: org_study_id