Nanofiber Scaffold for Rotator Cuff Tears

Recruiting at 10 trial locations

Overseen By Elsa l Englund Kayuha, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Revision surgery, Partial tears, Massive tears, Tobacco, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

91 Participants Needed

Trial Summary

What is the purpose of this trial?

Randomized controlled trial of patients over the age of 55 treated with and without a nanofiber scaffold during rotator cuff repair.

Research Team

Brian L Badman, MD

Principal Investigator

Central Indiana Orthopedics

Elsa I Englund Kayuha, MD

Principal Investigator

Atreon Orthopedics

Eligibility Criteria

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.

Inclusion Criteria

I am 55 years old or older.

I have been diagnosed with a rotator cuff tear.

Able to provide informed consent

Exclusion Criteria

I have a large tear in my shoulder tendon, over 5cm.

Patients with current tobacco history

I am having or have had a second surgery on my rotator cuff.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Treatment

Participants undergo rotator cuff repair with or without the nanofiber scaffold

Immediate post-surgery

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for healing, strength, and functional outcomes

24 months

Regular visits at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• nanofiber scaffold
• Rotium nanofiber graft

Trial Overview 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.

Participant Groups

Group I: Group 2 Scaffold Active Control 1 Intervention

Group 2 will undergo rotator cuff repair with suture anchors and incorporation of the nanofiber scaffold.

Group II: Group 1 Control Active Control 1 Intervention

Group 1 will serve as the control and undergo routine rotator cuff repair with suture anchors without the nanofiber scaffold.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Atreon Orthopedics

Lead Sponsor

Trials

2

Recruited

90+