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

NCT04599673 | Unknown Phase 4

• 1 other identifier: 20-CT7-30(200527-1)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

AMNIOGEN

EXPERIMENTAL

Intraoperative1 kit of AMNIOGEN injection into shoulder joint after RCT repair.

Drug: AMNIOGEN

Normal saline

PLACEBO COMPARATOR

Intraoperative 10 ml of normal saline injection into shoulder joint after RCT repair.

Other: normal saline

Interventions

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.

AMNIOGEN

normal saline OTHER

10 ml normal saline

Normal saline

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• receiving unilateral shoulder RCT repair in our hospital postoperative follow-up over 3 month

You may not qualify if:

• postoperative follow-up less than 3 month possible pregnency with coagulation disease NSAIDs intake during study period

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Yi Ping Wei

Kaohsiung City, 813, Taiwan

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yi Ping Wei, MD

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Ping Wei, MD

CONTACT

+886-7-342-2121; xgoznas22@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: October 23, 2020
• Study Start: October 15, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2022
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)