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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test how well the ActiveMatrix® graft, a connective tissue allograft, aids healing and improves shoulder function after rotator cuff repair surgery. It includes different groups to compare two dosages of ActiveMatrix® with a saline injection placebo. Individuals with a full-thickness tear in one or two rotator cuff tendons, who have not benefited from physical therapy, might be suitable candidates for this trial.

As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment approach.

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 prior data suggests that the ActiveMatrix® graft is safe for rotator cuff repair?

Research has shown that acellular human dermal matrix allografts, such as ActiveMatrix, can achieve over 80% healing in challenging rotator cuff repair cases. These studies suggest that such treatments are generally well-tolerated. Although specific safety data for ActiveMatrix isn't detailed in the sources, similar treatments have demonstrated positive results with few serious side effects.

This information indicates that ActiveMatrix might be a safe option for those considering joining a trial. However, discussing potential risks with the trial team remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

ActiveMatrix® is unique because it introduces a novel approach to rotator cuff repair, which traditionally relies on surgical techniques and physical therapy. Unlike these standard treatments, ActiveMatrix® works by utilizing a bioengineered scaffold designed to enhance the body's natural healing process, potentially improving tissue regeneration. This could mean faster recovery times and more effective healing for patients, which makes researchers optimistic about its potential impact on rotator cuff injuries.

What evidence suggests that the ActiveMatrix® graft is effective for rotator cuff repair?

Research has shown that acellular human dermal matrix allografts, such as ActiveMatrix®, can achieve over 80% healing in challenging rotator cuff repair cases. These allografts, made from human tissue, aid in repairing and healing damaged areas. Previous studies demonstrated that this type of patch yields better results for rotator cuff tears than partial repair alone. The data suggest that ActiveMatrix® significantly enhances healing and shoulder function post-surgery. This trial will compare different dosages of ActiveMatrix® to assess its effectiveness in improving shoulder recovery. ^{1 2 3 4 6}

Who Is on the Research Team?

Eric F Berkman, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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.

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

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 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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05894265

NCT05894265 | Prospective Study to Determine the Safety ... 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 ...

2. trialx.com trialx.com/clinical-trials/listings/315902/prospective-study-to-determine-the-safety-and-effectiveness-of-a-connective-tissue-allograft-active-matrix-am-vs-standard-of-care-in-arthroscopic-rotator-cuff-repair/

Clinical Research Trial Listing ( Rotator Cuff Tears ... Overview. The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5441617/

Outcome of partial repair of massive rotator cuff tears with ... Human tissue matrix allograft provides a better outcome for open bridging of irreparable rotator cuff tears than partial repair alone.

4. withpower.com withpower.com/trial/phase-rotator-cuff-injuries-5-2023-678da

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 ...

5. uth.trialstoday.org uth.trialstoday.org/trial/NCT05894265

UTHealth | Clinical Trials Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Active Matrix (AM) vs. Standard of Care in ...

6. trials.arthritis.org trials.arthritis.org/trials/NCT05844930

Study Purpose - Clinical Trial Finder - Arthritis Foundation A Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) Verses Standard of Care in Adhesive Capsulitis of the Shoulder.