BioEnthesis Augmentation for Rotator Cuff Tears

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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair.

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 data supports the effectiveness of the treatment BioEnthesis Augmentation for Rotator Cuff Tears?

Research shows that using a bioinductive collagen implant, similar to BioEnthesis Augmentation, can improve healing rates and reduce retear rates in rotator cuff repairs, leading to better outcomes for patients. ^{1 2 3 4 5}

Is BioEnthesis Augmentation safe for humans?

Research on biologic augmentation for rotator cuff repairs, including methods like acellular human dermal matrix and bioabsorbable collagen implants, has been conducted to assess safety and effectiveness. These studies suggest that such treatments are generally safe, but more high-quality research is needed to fully understand their safety profile. ^{5 6 7 8 9}

How is the BioEnthesis Augmentation treatment different from other treatments for rotator cuff tears?

BioEnthesis Augmentation is unique because it uses a bio-inductive collagen implant to enhance healing and reduce retear rates after rotator cuff repair. This approach combines the benefits of bio-induction, which promotes new tissue formation, with structural support, unlike traditional methods that may lack one of these aspects. ^{4 10 11 12 13}

Research Team

Jonathan Dickens, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Superior Capsular Reconstruction With the Long Head of the Biceps Autograft Prevents Infraspinatus Retear in Massive Posterosuperior Retracted Rotator Cuff Tears. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Double-Row Rotator Cuff Repair Technique With Dermal Allograft Augmentation. [2023]

3. United States 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. [2023]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes Following Biologically Enhanced Patch Augmentation Repair as a Salvage Procedure for Revision Massive Rotator Cuff Tears. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A prospective, randomized evaluation of acellular human dermal matrix augmentation for arthroscopic rotator cuff repair. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Rationale for Biologic Augmentation of Rotator Cuff Repairs. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Increasing pullout strength of suture anchors in osteoporotic bone using augmentation--a cadaver study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Biologic augmentation of rotator cuff repair. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic Rotator Cuff Repair Technique Using a Bio-Composite Scaffold for Tissue Augmentation. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Biologic augmentation in rotator cuff repair--should we do it, who should get it, and has it worked? [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Transtendinous Rotator Cuff Tear Repair with Bone Marrow Aspirate Concentrate Dermal Allograft Augmentation. [2021]