ActiveMatrix for Rotator Cuff Repair

Overseen By Layla Haidar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Steroids

Disqualifiers: Prior shoulder surgery, Osteoarthritis, Chronic pain, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery and immediate recovery

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery

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, if you have had a steroid injection in the shoulder within 6 weeks of enrollment, you may not be eligible to participate.

What data supports the effectiveness of the treatment ActiveMatrix for rotator cuff repair?

Research shows that using acellular human dermal matrix allografts, similar to ActiveMatrix, can lead to over 80% healing in difficult rotator cuff repair cases. These grafts help in tissue repair by promoting new tissue growth and reducing inflammation, making them effective in treating large rotator cuff tears. ^{1 2 3 4 5}

Is ActiveMatrix safe for use in humans?

Research on acellular human dermal matrix (AHDM) allografts, similar to ActiveMatrix, shows they have been used safely in rotator cuff repairs, with studies focusing on their use in shoulder surgeries. These studies generally report on safety and effectiveness, indicating that AHDM is a safe option for such procedures. ^{2 3 4 6 7}

What makes the ActiveMatrix treatment unique for rotator cuff repair?

ActiveMatrix is unique because it uses a connective tissue allograft (a tissue graft from a donor) that provides a scaffold to support tissue regeneration, similar to how collagen matrices are used in cartilage repair. This approach may offer an alternative to traditional surgical methods by promoting natural healing processes. ^{8 9 10 11 12}

Research Team

Eric F Berkman, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for adults with a specific type of shoulder injury called a full-thickness rotator cuff tear, who have tried physical therapy or exercises without success. They must be able to follow the study's procedures and attend all follow-ups. People can't join if they've had certain other shoulder issues, recent surgery on that shoulder, are involved in litigation related to injuries, have chronic pain disorders like fibromyalgia, substance abuse problems, or women who are pregnant or not using contraception.

Inclusion Criteria

I tried physical therapy or exercises for 4-6 weeks for my shoulder tear but it didn't help.

I have 1 or 2 full thickness tears in my rotator cuff that can be repaired.

My shoulder injury can be fixed by reattaching the tendon with little tension.

Exclusion Criteria

I have advanced shoulder arthritis according to the Samilson-Prieto classification.

I am not pregnant, breastfeeding, or planning to become pregnant, and I can use birth control during the study.

I had surgery on my shoulder within the last year, including procedures like Latarjet or rotator cuff repair.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo arthroscopic rotator cuff repair surgery with either ActiveMatrix® graft or standard of care

Surgery and immediate recovery

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, 4 weeks, 3 months, 6 months, 9 months, and 12 months

12 months

Multiple visits at specified intervals

Treatment Details

Interventions

• ActiveMatrix®

Trial Overview The study tests how well ActiveMatrix® graft helps heal and improve function after rotator cuff repair surgery compared to just saline injection (standard care). Participants will receive one of two different doses of ActiveMatrix® or a saline injection during their surgery.

Participant Groups

Group I: ActiveMatrix® Dosage B Experimental Treatment 1 Intervention

Group II: ActiveMatrix® Dosage A Experimental Treatment 1 Intervention

Group III: Saline Injection Placebo Group 1 Intervention

ActiveMatrix® is already approved in United States, European Union for the following indications:

Approved in United States as ActiveMatrix graft for:

• Rotator cuff repair augmentation in patients with large complex tears or impaired tissue quality

Approved in European Union as ActiveMatrix graft for:

• Rotator cuff repair augmentation in patients with large complex tears or impaired tissue quality

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Skye Biologics

Industry Sponsor

Trials

2

Recruited

340+

Skye Biologics Holdings, LLC

Industry Sponsor

Trials

4

Recruited

540+

Skye Biologics

Collaborator

Trials

2

Recruited

340+

Findings from Research

Acellular human dermal matrix allografts are being effectively used to enhance or replace severely damaged rotator cuff tissue, showing promising results in surgical outcomes.

There is an expectation of over 80% healing success in challenging cases of revision surgery after massive failed rotator cuff repairs, highlighting the potential of tissue engineering in orthopedic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Reflections From a Mature Arthroscopic Shoulder Surgeon on the History and Current Benefits of Augmentation for the Revision of a Massive Rotator Cuff Tear Using Acellular Human Dermal Matrix Allograft. Snyder, SJ.[2018]

In a study of 45 patients with massive rotator cuff tears treated with GraftJacket allograft, significant clinical improvement was observed, with UCLA scores increasing from 18.4 preoperatively to 27.5 postoperatively, indicating effective pain relief and function enhancement.

The arthroscopic technique using GraftJacket is a safe and minimally invasive alternative to more invasive procedures like tendon transfers or shoulder arthroplasty, showing high patient satisfaction and low morbidity, suggesting it could be a promising option for managing irreparable rotator cuff tears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic GraftJacket repair of rotator cuff tears. Wong, I., Burns, J., Snyder, S.[2022]

In a study of 28 patients who underwent revision rotator cuff repair augmented with acellular human dermal matrix (AHDM), 82% were followed for at least 2 years, showing that AHDM augmentation is a safe and effective treatment for full-thickness rotator cuff retears.

Postoperative outcomes indicated significant improvements in shoulder function, with ASES scores increasing from 56 to 85 and SANE scores from 42 to 76, highlighting the efficacy of this intervention despite a retear rate of 31% in those who underwent imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of arthroscopic revision rotator cuff repair with acellular human dermal matrix allograft augmentation. Hohn, EA., Gillette, BP., Burns, JP.[2018]

In a study of 60 patients with large rotator cuff tears, those who received acellular human dermal matrix allograft augmentation showed significantly greater improvement in American Shoulder and Elbow Surgeons (ASES) scores compared to the control group, indicating enhanced clinical outcomes.

The retear rate was significantly lower in the allograft group (9.1%) compared to the control group (38.1%), suggesting that allograft augmentation may help reduce the risk of retear, especially when the rotator cuff footprint is completely covered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Anatomical Outcomes of Arthroscopic Repair of Large Rotator Cuff Tears with Allograft Patch Augmentation: A Prospective, Single-Blinded, Randomized Controlled Trial with a Long-term Follow-up. Lee, GW., Kim, JY., Lee, HW., et al.[2022]

A biopsy from a 62-year-old man three months after rotator cuff augmentation with the GraftJacket Matrix-MaxForce Extreme showed intact graft material with significant blood vessel growth and elastic fibers, indicating good integration with the host tissue.

The study found minimal inflammatory response and no signs of calcification or infection, suggesting that this acellular human dermal graft is safe and effective for promoting tissue remodeling in rotator cuff repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histologic evaluation of a biopsy specimen obtained 3 months after rotator cuff augmentation with GraftJacket Matrix. Snyder, SJ., Arnoczky, SP., Bond, JL., 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 129 patients with full-thickness rotator cuff tears, injections of atelocollagen and acellular dermal matrix (ADM) allograft did not show superior clinical outcomes compared to standard arthroscopic repair alone over a 12-month follow-up period.

The study found that while the nonhealing and retear rates were lower in the groups receiving injections (4% and 2% respectively for ADM), these differences were not statistically significant, and no adverse events were reported, indicating the safety of the injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of intraoperative injection of collagen in arthroscopic repair of full-thickness rotator cuff tear: a retrospective cohort study. Aldhafian, OR., Choi, KH., Cho, HS., et al.[2023]

Matrix-induced autologous cartilage regeneration (MACR) using a type I collagen hydrogel has been shown to be a safe and effective alternative for treating both small and large cartilage lesions, with positive clinical and imaging results.

MACR is emerging as a competitive treatment option compared to traditional methods like microfracture and matrix-associated autologous cartilage cell transplantation (MACT), particularly due to its reliance on a cross-linked collagen matrix that stimulates cartilage regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cartilage Regeneration with Cell-free Type 1 Collagen Matrix - Past, Present and Future (Part 1 - Clinical Aspects). Roessler, PP., Efe, T., Wirtz, DC., et al.[2022]

In a study of 4 young male patients (average age 29.3 years) who underwent autologous chondrocyte transplantation for large cartilage defects in the shoulder, results showed significant improvement in pain and shoulder function after an average follow-up of 41.3 months.

MRI evaluations indicated satisfactory coverage of cartilage defects with signs of fibrocartilaginous repair, suggesting that this technique may be a viable option for treating large cartilage lesions in young adults, although further research is needed to confirm its long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early clinical and structural results after autologous chondrocyte transplantation at the glenohumeral joint. Buchmann, S., Salzmann, GM., Glanzmann, MC., et al.[2016]

In a study involving 20 patients with knee cartilage defects, both the MACI(®) and CaRes(®) matrix-based autologous chondrocyte transplantation (MACT) systems showed significant improvement in clinical outcomes after one year, with most patients experiencing increased activity levels, pain relief, and better knee function.

The MACI(®) implant was found to be easier to handle than the CaRes(®) implant, resulting in smaller incisions and shorter operation times, making it a potentially more efficient option for treating full-thickness cartilage defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two different matrix-based autologous chondrocyte transplantation systems: 1 year follow-up results. Flohé, S., Betsch, M., Ruße, K., et al.[2018]

In a study of 104 active-duty military patients who underwent meniscal allograft transplantation (MAT), only 20% were able to return to full, unrestricted military duty after 2 years, indicating a low likelihood of successful return to duty post-surgery.

Demographic factors such as age, gender, and BMI did not influence the return to duty, but combat arms soldiers had a higher chance of returning to full duty compared to support role soldiers, and officers were significantly more likely to return to duty than enlisted soldiers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Likelihood of Return to Duty Is Low After Meniscal Allograft Transplantation in an Active-duty Military Population. Antosh, IJ., Cameron, KL., Marsh, NA., et al.[2023]

In a study of 23 patients evaluated 2 years after matrix-associated autologous chondrocyte transplantation (MACT) using the Novocart 3D scaffold, MRI results showed a mean MOCART score of 73.2, indicating good cartilage repair.

Clinical outcomes also improved significantly across various measures, including a mean IKDC score of 69.8 and substantial improvements in pain and quality of life, demonstrating the efficacy of MACT for treating large cartilage defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results 2 Years After Matrix-Associated Autologous Chondrocyte Transplantation Using the Novocart 3D Scaffold: An Analysis of Clinical and Radiological Data. Zak, L., Albrecht, C., Wondrasch, B., et al.[2022]

References

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

Editorial Commentary: Reflections From a Mature Arthroscopic Shoulder Surgeon on the History and Current Benefits of Augmentation for the Revision of a Massive Rotator Cuff Tear Using Acellular Human Dermal Matrix Allograft. [2018]

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

Arthroscopic GraftJacket repair of rotator cuff tears. [2022]

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

Outcomes of arthroscopic revision rotator cuff repair with acellular human dermal matrix allograft augmentation. [2018]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Clinical and Anatomical Outcomes of Arthroscopic Repair of Large Rotator Cuff Tears with Allograft Patch Augmentation: A Prospective, Single-Blinded, Randomized Controlled Trial with a Long-term Follow-up. [2022]

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

Histologic evaluation of a biopsy specimen obtained 3 months after rotator cuff augmentation with GraftJacket Matrix. [2022]

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

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

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

Outcome of intraoperative injection of collagen in arthroscopic repair of full-thickness rotator cuff tear: a retrospective cohort study. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Cartilage Regeneration with Cell-free Type 1 Collagen Matrix - Past, Present and Future (Part 1 - Clinical Aspects). [2022]

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

Early clinical and structural results after autologous chondrocyte transplantation at the glenohumeral joint. [2016]

10. Germany pubmed.ncbi.nlm.nih.gov

Comparison of two different matrix-based autologous chondrocyte transplantation systems: 1 year follow-up results. [2018]

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

Likelihood of Return to Duty Is Low After Meniscal Allograft Transplantation in an Active-duty Military Population. [2023]

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

Results 2 Years After Matrix-Associated Autologous Chondrocyte Transplantation Using the Novocart 3D Scaffold: An Analysis of Clinical and Radiological Data. [2022]