Your session is about to expire
← Back to Search
Nanofiber Scaffold
Nanofiber Scaffold for Rotator Cuff Tears
N/A
Waitlist Available
Led By Brian Badman, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 55 and older
Primary diagnosis of rotator cuff tear
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
Awards & highlights
Study Summary
This trial found that patients treated with a nanofiber scaffold during rotator cuff repair had better outcomes than those without the scaffold.
Who is the study for?
This trial is for individuals over the age of 55 who have a primary diagnosis of a full-thickness rotator cuff tear and can give informed consent. It's not open to those with partial tears, massive tears larger than 5cm, a history of tobacco use, or anyone needing revision surgery.Check my eligibility
What is being tested?
The study is testing whether using a nanofiber scaffold during rotator cuff repair surgery helps in healing. Participants are randomly assigned to receive either the standard treatment or the same treatment plus the nanofiber scaffold.See study design
What are the potential side effects?
While specific side effects aren't listed, typical risks may include infection, inflammation at the surgical site, pain, stiffness in the shoulder joint, and possible allergic reactions to materials used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 55 years old or older.
Select...
I have been diagnosed with a rotator cuff tear.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Failure of the repair
Secondary outcome measures
Muscle Tissue
Change in patient-reported American Shoulder and Elbow Scores
Change in patient-reported Single Assessment Numeric Evaluation (SANE) score
+3 moreTrial Design
2Treatment groups
Active Control
Group I: Group 2 ScaffoldActive Control1 Intervention
Group 2 will undergo rotator cuff repair with suture anchors and incorporation of the nanofiber scaffold.
Group II: Group 1 ControlActive Control1 Intervention
Group 1 will serve as the control and undergo routine rotator cuff repair with suture anchors without the nanofiber scaffold.
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
981,710 Total Patients Enrolled
1 Trials studying Rotator Cuff Tears
78 Patients Enrolled for Rotator Cuff Tears
Atreon OrthopedicsLead Sponsor
1 Previous Clinical Trials
1 Trials studying Rotator Cuff Tears
Brian Badman, MDPrincipal InvestigatorAmerican Health Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 55 years old or older.I have a large tear in my shoulder tendon, over 5cm.I have been diagnosed with a rotator cuff tear.I am having or have had a second surgery on my rotator cuff.I have a partial tear in my shoulder's rotator cuff.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2 Scaffold
- Group 2: Group 1 Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it still possible to take part in this experiment?
"Evidently, the clinical trial is currently searching for candidates; this was initially posted on August 1st 2020 and its information has recently been revised as of April 4th 2022."
Answered by AI
Are there multiple venues administering this clinical experiment in the locale?
"11 different medical centres are hosting this trial, including in Rochester, New Castle and Dallas. It is recommended to choose the site nearest you to reduce travel requirements if accepted into the program."
Answered by AI
How many participants are actively taking part in this experiment?
"This experiment needs 240 eligible participants to be able to take place. The sponsor, Atreon Orthopedics, are running the trial from two locations; Tomaino Orthopedic Care for Shoulder, Hand and Elbow in Rochester NY and Henry Community Orthopedics in New Castle TX."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger