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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMNIOGEN | Experimental | Intraoperative1 kit of AMNIOGEN injection into shoulder joint after RCT repair. |
|
| Normal saline | Placebo Comparator | Intraoperative 10 ml of normal saline injection into shoulder joint after RCT repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMNIOGEN | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Ping Wei, MD | Contact | +886-7-342-2121 | xgoznas22@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Ping Wei, MD | Kaohsiung Veterans General Hospital. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yi Ping Wei | Recruiting | Kaohsiung City | 813 | Taiwan |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| normal saline | Other | 10 ml normal saline |
|