Rotator Cuff Tears
Conditions
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.
Interventions
DRUGAMNIOGEN
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.
OTHERnormal saline
10 ml normal saline
Sponsors
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 100 of participants with preoperative and postoperative physical examination are accessed by Empty can test | postoperative 1 month | 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 | postoperative 3 month | size and site of rotator cuff tear was accessed by MRI T1 and T2 image; MRI was checked by one orthopedist |
Countries
Taiwan
Contacts
Primary ContactYi Ping Wei, MD
Outcome results
None listed