Rotator Cuff TearsPhase 4NCT04599673
Prospective Analysis of Intraoperative AMNIOGEN® Injection in Patients With Rotator Cuff Tear
A Phase 4 study testing AMNIOGEN and normal saline in people with Rotator Cuff Tears, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- AMNIOGEN and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Oct 2020to 30 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- receiving unilateral shoulder RCT repair in our hospital postoperative follow-up over 3 month
Who cannot join
- postoperative follow-up less than 3 month possible pregnency with coagulation disease NSAIDs intake during study period
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Yi Ping Wei
Kaohsiung City, 813
Yi P Wei, +88673422121, xgoznas22@gmail.com
About this study
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
- Being tested
- AMNIOGEN, normal saline
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMNIOGENDrug
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 salineOther
10 ml normal saline
| Study group | Role | What they receive |
|---|---|---|
| AMNIOGEN | Experimental | Intraoperative1 kit of AMNIOGEN injection into shoulder joint after RCT repair. Receives: Drug: AMNIOGEN |
| Normal saline | Placebo comparator | Intraoperative 10 ml of normal saline injection into shoulder joint after RCT repair. Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: postoperative 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start15 Oct 2020 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Ping Wei, Kaohsiung Veterans General Hospital.
- Investigators
- Yi Ping Wei, MD, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599673
- Sponsor's protocol ID
- 20-CT7-30(200527-1)
- Status last verified
- Oct 2020
- First submitted
- 13 Sep 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Intraoperative AMNIOGEN® Injection in Patients With Rotator Cuff Tear
- ClinicalTrials.gov ID
- NCT04599673
- Acronym / sponsor ID
- 20-CT7-30(200527-1)
- Conditions
- Rotator Cuff Tears
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMNIOGEN | Experimental | Drug: AMNIOGENIntraoperative1 kit of AMNIOGEN injection into shoulder joint after RCT repair. |
| Normal saline | Placebo comparator | Other: normal salineIntraoperative 10 ml of normal saline injection into shoulder joint after RCT repair. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- receiving unilateral shoulder RCT repair in our hospital postoperative follow-up over 3 month
Key exclusion criteria (1 listed)
- postoperative follow-up less than 3 month possible pregnency with coagulation disease NSAIDs intake during study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMNIOGENAmnioGen® 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. | Drug | AMNIOGEN |
| normal saline10 ml normal saline | Other | Normal saline |
Primary outcome
100 of participants with preoperative and postoperative physical examination are accessed by Empty can test
Time frame: 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 physical examination are accessed by Empty can test
Time frame: postoperative 3 month
the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist
100 of participants with preoperative and postoperative physical examination are accessed by Empty can test
Time frame: postoperative 12 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
Time frame: postoperative 3 month
size and site of rotator cuff tear was accessed by MRI T1 and T2 image; MRI was checked by one orthopedist
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff Tears
Active, not recruitingPhase 1
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Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
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SMR Stemless Reverse vs SMR Reverse Shoulder System
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Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Ping Wei, MD principal investigator
Kaohsiung Veterans General Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AMNIOGEN and normal saline in people with Rotator Cuff Tears, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Ping Wei, MD (+886-7-342-2121, xgoznas22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100 of participants with preoperative and postoperative physical examination are accessed by Empty can test (time frame: postoperative 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.