BioEnthesis Augmentation for Rotator Cuff Tears

Not yet recruiting at 1 trial location

Overseen By Andrew Sheean, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Brooke Army Medical Center

Disqualifiers: Previous shoulder surgery, Tobacco use, Systemic arthritis, Significant neck pathology, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: Day of surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BioEnthesis Augmentation, designed to improve healing after rotator cuff surgeries. Rotator cuff tears can be difficult to repair, and current methods often result in re-tears. BioEnthesis Augmentation may create a stronger bond between the tendon and bone, potentially reducing pain and improving mobility. The trial compares BioEnthesis Augmentation to standard surgical techniques. Individuals with a reparable rotator cuff tear who can undergo surgery and commit to a 12-month follow-up might be suitable candidates. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants cannot have certain conditions or be involved in other clinical trials that might affect safety or results.

What is the safety track record for BioEnthesis Augmentation?

In a previous study, the BioEnthesis treatment, which uses a special material to help repair rotator cuff injuries, showed promising safety results. Research indicates that this treatment has already been tested in people and was found safe for further study. Those earlier studies did not report any major safety issues, suggesting that the treatment is generally well-tolerated. Because this trial is in a late phase, the treatment has already demonstrated a good safety record in earlier stages. Overall, participants in BioEnthesis trials have not reported significant side effects, making it a potentially safe option for those considering joining this study. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for rotator cuff tears, which involves traditional suture and anchor techniques, BioEnthesis Augmentation uses an allogenic, acellular, biphasic allograft. This unique structure is designed to support and enhance natural healing processes. Researchers are excited because this approach could potentially offer improved integration with the body's tissues, leading to faster and more effective recovery. The BioEnthesis method might also reduce the risk of re-tears, a common issue with current repair techniques.

What evidence suggests that BioEnthesis Augmentation is effective for rotator cuff tears?

This trial will compare BioEnthesis Augmentation with the standard of care for rotator cuff tears. Research has shown that BioEnthesis Augmentation might lower the risk of re-tearing in rotator cuff injuries. In an animal study, BioEnthesis led to fewer re-tears and better MRI results compared to traditional methods, even in older patients. Another study suggested that using a patch like BioEnthesis can improve repair success in patients at high risk. However, in a study of 22 patients with large tears, only 41% experienced significant benefits from the biologically enhanced patch repair. While some results are promising, effectiveness can vary, and ongoing research aims to better understand its potential benefits. ^{3 4 5 6 7}

Who Is on the Research Team?

Jonathan Dickens, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for individuals with rotator cuff injuries requiring surgery. Ideal candidates are those who have not had success with standard treatments and are looking for an alternative that may improve tendon-bone healing and reduce the chance of re-injury.

Inclusion Criteria

Fluency in speaking, reading, comprehending English

DEERS-eligible

I am fit for surgery to fix a torn rotator cuff.

Exclusion Criteria

I have been diagnosed with systemic arthritis.

Current or planned pregnancy during the study

History of substance abuse or addiction

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo rotator cuff repair with either BioEnthesis augmentation or standard suture anchor-based technique

Day of surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 3, 6, and 12 months post-operation

12 months

3 visits (in-person)

Long-term follow-up

Participants continue to be monitored for re-tear rates and other outcomes beyond the initial follow-up period

Additional 12 months

What Are the Treatments Tested in This Trial?

Interventions

• BioEnthesis Augmentation

Trial Overview The MIRROR Project 44 compares two surgical methods for repairing rotator cuff tears: one using a new technique called BioEnthesis augmentation, which aims to better connect tendon to bone, versus traditional repairs without this technology.

How Is the Trial Designed?

Group I: BioEnthesis Experimental Treatment 1 Intervention

Allogenic, acellular, biphasic allograft (BioEnthesis)

Group II: Standard of Care Active Control 1 Intervention

Standard rotator cuff repair (suture and anchor based technique)

Who Is Running the Clinical Trial?

Brooke Army Medical Center

Lead Sponsor

Trials

134

Recruited

28,100+

Sparta Biopharma

Collaborator

Trials

1

Recruited

100+

Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Collaborator

Trials

4

Recruited

280+

Published Research Related to This Trial

The BioBrace™ is a novel bio-inductive scaffold designed for rotator cuff augmentation, combining the benefits of tissue induction and structural strength, which addresses the limitations of existing treatments.

This innovative implant uses a unique composition of type I collagen and bio-resorbable microfilaments, aiming to enhance tissue incorporation while providing immediate support during the healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Rotator Cuff Repair Technique Using a Bio-Composite Scaffold for Tissue Augmentation. Cheesman, QT., Szukics, PF., Stark, M., et al.[2022]

In a study of 22 patients with massive rotator cuff tears, only 41% achieved substantial clinical benefit from biologically enhanced patch augmentation repair, indicating that while some patients improved, many did not experience significant recovery.

The procedure showed a significant increase in shoulder function as measured by the Simple Shoulder Test, but pain score improvements were not statistically significant, suggesting that while the technique may enhance function, it may not effectively reduce pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes Following Biologically Enhanced Patch Augmentation Repair as a Salvage Procedure for Revision Massive Rotator Cuff Tears. Muench, LN., Kia, C., Jerliu, A., et al.[2020]

The bioinductive collagen implant used for treating partial- and full-thickness rotator cuff tears demonstrated significant safety and efficacy, with patients showing marked improvements in pain and function at 1-year follow-up, as measured by various standardized outcomes.

In the study involving patients with rotator cuff tears, 84% of those with partial tears and 72% of those with full-thickness tears reported clinically meaningful improvements in pain and shoulder function, indicating the implant's effectiveness in promoting healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears. McIntyre, LF., Bishai, SK., Brown, PB., et al.[2020]

In a study of 115 patients with full-thickness rotator cuff tears, the use of a bioinductive bovine collagen implant during repair resulted in a low retear rate of 16.5% at one year, which is favorable compared to existing literature.

Patients showed significant improvement in shoulder function, with 91.7% meeting the minimally clinically important difference in the American Shoulder and Elbow Surgeons (ASES) score at one year, indicating that the collagen implant may enhance recovery outcomes after rotator cuff repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: a prospective multicenter study. Bushnell, BD., Connor, PM., Harris, HW., et al.[2022]

Acellular human dermal matrix augmentation during arthroscopic repair of large rotator cuff tears significantly improved functional outcomes, with ASES scores increasing from 48.5 to 98.9 compared to 46.0 to 94.8 in the non-augmented group (P = .035).

MRI results showed that 85% of repairs in the augmented group were intact, compared to only 40% in the non-augmented group (P < .01), and no adverse events were linked to the use of the matrix grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomized evaluation of acellular human dermal matrix augmentation for arthroscopic rotator cuff repair. Barber, FA., Burns, JP., Deutsch, A., et al.[2022]

In a study of 48 patients with large and massive rotator cuff tears, both those who received a bio-inductive collagen implant and those who did not showed significant improvements in shoulder function and pain relief after surgery, indicating that both methods are effective.

Magnetic resonance imaging results showed similar healing rates between the two groups, with 55% of the collagen implant group and 53% of the control group having intact repairs, suggesting that while both approaches improve outcomes, the addition of the collagen implant does not significantly enhance healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Repair of Retracted Large and Massive Rotator Cuff Tears with and without Augmentation with a Bio-Inductive Collagen Implant Reveals Substantial and Comparable Clinical Improvement. Zhang, T., Ajayi, A., Hajjar, M., et al.[2023]

Citations

1. bioenthesis.com bioenthesis.com/

BioEnthesis™ BioEnthesis®​​ in ovine model. Despite significantly older patients, BioEnthesis showed fewer retears and significantly better MRIs.

2. withpower.com withpower.com/trial/phase-4-rotator-cuff-injuries-1-2024-a25e4

BioEnthesis Augmentation for Rotator Cuff Tears In a study of 22 patients with massive rotator cuff tears, only 41% achieved substantial clinical benefit from biologically enhanced patch augmentation repair, ...

3. dukehealth.org dukehealth.org/clinical-trials/directory/pro00115384

BioEnthesis Study (Rotator Cuff Repair) - Clinical Trial We are doing this study to test if an experimental medical device called the Bioenthesis® implant (the study device) is a safe and effective option for people ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9051627/

Arthroscopic Rotator Cuff Repair with Biphasic ... Arthroscopic rotator cuff repair is frequently performed with overall positive clinical improvement and long-term outcomes. Despite clinical ...

5. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(23)00265-7/fulltext

Biphasic Interpositional Allograft for Rotator Cuff Repair ... Patch augmentation of RCR is a popular technique that has shown clinical success in improving the likelihood of a successful repair in patients at elevated risk ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06289686

MIRROR Project 44 - Rotator Cuff Repairs With or Without ... Rates of re-tear, Re-tear rates following rotator cuff repair using BioEnthesis versus standard of care. Assessed with (1) 12-month follow-up shoulder MRI ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8144684/

Augmentation of rotator cuff repairs” - PMC Rotator cuff tears (RCTs) are common injuries of the shoulder predominantly ... rotator cuff tears: 2-year safety and clinical outcomes. Am J Sports ...