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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Drug: AMNIOGEN
* Other: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMNIOGEN<br>Intraoperative1 kit of AMNIOGEN injection into shoulder joint after RCT repair. | Drug: AMNIOGEN<br>* 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.<br>|
| Placebo Comparator: Normal saline<br>Intraoperative 10 ml of normal saline injection into shoulder joint after RCT repair. | Other: normal saline<br>* 10 ml normal saline<br>|

What is the study measuring?
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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 |