Nanofiber Scaffold for Rotator Cuff Tears

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for rotator cuff tears, which are shoulder injuries. Researchers aim to determine if using a nanofiber scaffold, known as the Rotium nanofiber graft, during surgery improves recovery compared to the usual repair method. Participants will be divided into two groups: one will undergo standard surgery, while the other will receive surgery with the added scaffold. The trial seeks individuals over 55 diagnosed with a rotator cuff tear who are preparing for their first surgery. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the nanofiber scaffold is safe for rotator cuff repair?

Research has shown that using a nanofiber scaffold in rotator cuff repairs is promising for safety and effectiveness. One study found that 91% of tendons healed well with this scaffold, and patients reported significant improvements in feeling and movement. This indicates the treatment is safe and aids recovery.

Another study highlighted that this scaffold, which is entirely man-made and naturally degrades in the body, can significantly increase the strength of rotator cuff repairs. This means it not only supports healing but does so without causing major issues.

While these results are encouraging, more research is needed to fully understand the long-term safety of the nanofiber scaffold. However, current evidence suggests it is generally safe for patients undergoing rotator cuff repair. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard rotator cuff repair, which typically relies on suture anchors alone, the nanofiber scaffold introduces a new twist by incorporating a specially designed scaffold into the repair process. This scaffold acts like a supportive bridge, encouraging the body’s natural tissue to regenerate and strengthen the repair site more effectively. Researchers are excited about this approach because it has the potential to enhance healing and reduce re-tear rates, offering a more robust recovery for patients compared to traditional methods.

What evidence suggests that the nanofiber scaffold is effective for rotator cuff tears?

Research has shown that using a nanofiber scaffold during rotator cuff surgery can lead to better outcomes. In this trial, participants in Group 2 will undergo rotator cuff repair with suture anchors and the incorporation of the nanofiber scaffold. One study found that 91% of tendons healed when this scaffold was used, and patients experienced improved movement and comfort. Another study demonstrated that this fully synthetic, body-absorbable scaffold strengthens the repair. Rotator cuff surgeries often fail, especially with large tears, but this scaffold appears to improve success rates. Overall, the nanofiber scaffold shows promise for aiding recovery and reducing the risk of re-injury. ^{1 3 4 6 7}

Who Is on the Research Team?

Brian L Badman, MD

Principal Investigator

Central Indiana Orthopedics

Elsa I Englund Kayuha, MD

Principal Investigator

Atreon Orthopedics

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9118444/

Use of a Nanofiber Resorbable Scaffold During Rotator Cuff ... The use of the scaffold resulted in a 91% tendon healing rate and significant improvements in functional and patient-reported outcome measures.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666638324003955

Biomechanical enhancement in rotator cuff repairs This study provides compelling evidence that the use of a fully synthetic, bioresorbable nanofiber scaffold in rotator cuff repair significantly improves ...

3. mdpi.com mdpi.com/2227-9059/12/7/1613

Nanofiber Graft Therapy to Prevent Shoulder Stiffness and ... This review critically assesses the efficacy and limitations of nanofiber-based methods in promoting rotator cuff (RC) regeneration and managing postrepair ...

4. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(22)00257-2/fulltext

Rotator Cuff Repair Augmented With Interpositional ... Despite advances in arthroscopic rotator cuff repair, failure rates up to 94% have been reported in the literature for large tears, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2212628725000453

Bioaugmentation of Rotator Cuff Repair With an ... Rotator cuff repairs demonstrate variable success, with reported retear rates from 4% to 94%, and the highest retear rates are associated with large and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11274509/

Nanofiber Graft Therapy to Prevent Shoulder Stiffness and ... This review critically assesses the efficacy and limitations of nanofiber-based methods in promoting rotator cuff (RC) regeneration and managing postrepair ...

7. withpower.com withpower.com/trial/phase-rotator-cuff-injuries-7-2020-ab78c

Nanofiber Scaffold for Rotator Cuff Tears · Info for Participants Trial Overview The study is testing whether using a nanofiber scaffold during rotator cuff repair surgery helps in healing. Participants are randomly assigned ...