Subscapularis Repair Techniques for Shoulder Injuries

Recruiting at 1 trial location

Overseen By Jessica Nguyen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Vulnerable population

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

Compensation: Varies

Number of Visits: 9

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to repair the subscapularis muscle during shoulder replacement surgery. Researchers aim to determine if using a Biobrace (also known as Pitch Patch or Regeneten Patch), a special support, is more effective than the standard method of stitching the muscle. They will compare ultrasound images and assess differences in recovery and function. The trial seeks participants planning to undergo total shoulder replacement. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance shoulder surgery outcomes.

Do I need 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 these subscapularis repair techniques are safe?

Research has shown that BioBrace augmentation is generally safe for patients. A review of medical records from 267 patients demonstrated positive safety results. Another study on a similar collagen patch found it safe for repairing rotator cuffs, suggesting that BioBrace, made from a similar material, is likely safe to use.

Standard repair with stitches is common in surgeries and considered safe and routine, involving the reattachment of tissue with stitches.

Both treatments have good safety records based on past evidence. No serious side effects have been reported with these repair methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer new ways to repair the subscapularis during shoulder replacement surgery. Traditionally, this involves using sutures to reattach the muscle, which can sometimes be insufficient if the tissue quality is poor. The BioBrace Augmentation introduces a novel approach by reinforcing the standard repair with an additional supportive material, potentially leading to stronger and more durable repairs. This could result in better outcomes for patients, as it aims to enhance the strength and robustness of the shoulder repair compared to standard suture techniques alone.

What evidence suggests that these subscapularis repair techniques could be effective for shoulder injuries?

This trial will compare two techniques for subscapularis repair during shoulder replacement surgery: the BioBrace augmentation and the standard repair with sutures. Research has shown that the BioBrace patch, used to aid in repairing the subscapularis muscle, yields promising results in similar surgeries. Studies on this patch for rotator cuff repairs have demonstrated high healing rates, with up to 90.7% success when combined with surgery. The patch also appears to reduce the likelihood of re-injury, with re-tear rates ranging from 0% to 35% over several years. Additionally, patients have reported better outcomes and satisfaction with the patch. These findings suggest that the BioBrace patch might enhance the strength and success of subscapularis repairs. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Freehill, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals undergoing total shoulder arthroplasty, which is a type of shoulder replacement surgery. It's not suitable for vulnerable populations such as children, pregnant women, or those unable to consent.

Inclusion Criteria

I have had a total shoulder replacement.

Exclusion Criteria

Vulnerable population

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 shoulder replacement surgery with either standard repair or BioBrace augmentation

Surgery day

1 visit (in-person)

Post-Surgery Monitoring

Participants are monitored for signs of loosening or wear patterns on shoulder x-ray and assessed for shoulder condition using ASES score

2 weeks to 2 years

Multiple visits (in-person) at 2 weeks, 3 months, 6 months, 1 year, and 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including ultrasound assessments of subscapularis tissue

6 weeks to 1 year

Multiple visits (in-person) at 6 weeks, 3 months, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Pitch Patch Augmentation
• Standard Repair with Sutures

Trial Overview The study compares two methods of repairing the subscapularis tissue after shoulder replacement: standard suture repair versus augmentation with a product called BioBrace. The comparison will be based on ultrasound images and clinical outcomes.

How Is the Trial Designed?

Group I: BioBrace Augmentation Experimental Treatment 1 Intervention

During the shoulder replacement surgery (arthroplasty) in order to access the shoulder, the subscapularis is removed from its insertion in your upper arm bone. It is repaired in reverse total shoulder arthroplasty, but is sometimes not as robust as we would like based on tissue quality and other factors. A shoulder arthroplasty is when the ball and socket are replaced with prosthetic components. If randomized to the BioBrace, patient will receive BioBrace augmentation of the standard subscapularis repair.

Group II: Standard Repair with Sutures Active Control 1 Intervention

During the shoulder replacement surgery (arthroplasty) in order to access the shoulder, the subscapularis is removed from its insertion in your upper arm bone. It is repaired in reverse total shoulder arthroplasty, but is sometimes not as robust as we would like based on tissue quality and other factors. A shoulder arthroplasty is when the ball and socket are replaced with prosthetic components. If randomized to standard repair, patient will receive the standard repair with sutures.

Pitch Patch Augmentation is already approved in European Union, United States for the following indications:

Approved in European Union as Pitch Patch for:

• Reinforcement of the rotator cuff following or during repair by sutures or suture anchors, where weakness exists in the soft tissue

Approved in United States as Pitch Patch for:

• Reinforcement of the rotator cuff following or during repair by sutures or suture anchors, where weakness exists in the soft tissue

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Tulane University

Collaborator

Trials

129

Recruited

259,000+

Published Research Related to This Trial

Lesser tuberosity osteotomy provides a significantly stronger repair compared to subscapularis tenotomy during total shoulder arthroplasty, with a higher load to failure (443 N vs. 350 N).

While the mode of failure differs, with tenotomy primarily failing due to soft tissue issues and lesser tuberosity osteotomy failing due to bone issues, cyclic displacement between the two techniques was not statistically different.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lesser tuberosity osteotomy and subscapularis tenotomy repair techniques during total shoulder arthroplasty: A meta-analysis of cadaveric studies. Schrock, JB., Kraeutler, MJ., Houck, DA., et al.[2018]

A subscapularis-sparing approach in shoulder replacement surgery, where only 30% to 50% of the tendon is detached, allows for better preservation of shoulder function and quicker rehabilitation, as shown in a study of 43 patients with a minimum follow-up of 2 years.

Postoperative evaluations indicated that all patients maintained subscapularis strength comparable to the opposite side, with significant improvements in shoulder function scores and no instances of tendon rupture or muscle atrophy, highlighting the efficacy and safety of this surgical technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Subscapularis-Sparing Approach in Humeral Head Replacement. Savoie, FH., O'Brien, MJ.[2016]

Suture tape augmentation significantly increases the load at ultimate failure and construct stiffness of subscapularis peel repairs compared to traditional repair methods, with the augmentation group showing a load to failure of 585.1 N versus 358.5 N in the control group.

Despite the increased strength from augmentation, both repair methods showed no significant differences in displacement under cyclic loading, indicating that the suture tape does not compromise the stability of the repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical Evaluation of the Efficacy of Suture Tape Augmentation for Subscapularis Peel Repair. Wellington, IJ., Hewitt, CR., Hawthorne, BC., et al.[2023]

The management of the subscapularis muscle is crucial for successful outcomes in total shoulder arthroplasty, highlighting its importance in shoulder surgeries.

This article presents a stem-specific technique for repairing the subscapularis, which may improve surgical precision and patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stem-Based Repair of the Subscapularis in Total Shoulder Arthroplasty. Denard, PJ., Lederman, E., Gobezie, R., et al.[2022]

The management and repair technique of the subscapularis tendon during total shoulder arthroplasty is critical for its healing and overall shoulder function, with four main approaches: tenotomy, peel, lesser tuberosity osteotomy, and a newer subscapularis-sparing method.

There is ongoing debate in the literature about which technique offers the best strength and stability for subscapularis repair, highlighting the need for further biomechanical studies to determine the optimal approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Subscapularis Management and Repair Techniques. Dunn, R., Joyce, CD., Bravman, JT.[2021]

The 'Biceps-Subscap Sling' technique, which uses the long head of the biceps tendon (LHBT) to augment subscapularis repair after total shoulder arthroplasty, may enhance joint stability and prevent repair failure, particularly in at-risk patients.

This method not only provides additional structural support to the repair but also utilizes a biologically active autograft, making it a cost-effective option for improving postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subscapularis Repair Augmentation With the Long Head Biceps Tendon During Anatomic Total Shoulder Arthroplasty: The "Biceps-Subscap Sling" Technique. Cohn, MR., Fares, MY., Koa, J., et al.[2023]

Subscapularis tears are more common than previously thought, and repairing these full-thickness tears is crucial for maintaining shoulder function.

Both traditional deltopectoral and newer arthroscopic repair techniques yield similar positive outcomes, while irreparable tears can be addressed with evolving reconstructive options like tendon transfers and reverse shoulder arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subscapularis Tears: Evolution in Treatment Options. Lee, B., Patel, V., Itamura, J.[2022]

The novel technique for subscapularis repair during total shoulder arthroplasty allows for early postoperative motion, enhancing recovery and rehabilitation.

This approach has resulted in improved patient outcomes, particularly in range of motion after surgery, suggesting it should be adopted in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel technique for subscapularis repair in total shoulder arthroplasty. Meyers, A., Barnes, C., Dugarte, A., et al.[2023]

In a study using 18 human cadaveric shoulders, augmenting subscapularis peel repair with the long head of the biceps tendon (LHBT) significantly increased the load to failure and stiffness compared to traditional repair methods.

Both horizontal and V-shaped LHBT augmentations provided superior biomechanical properties, with the V-shaped repair showing the highest load to failure, indicating a more robust repair technique for subscapularis failure after total shoulder arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical evaluation of subscapularis peel repairs augmented with the long head of the biceps tendon for anatomic total shoulder arthroplasty. Hawthorne, BC., Shuman, ME., Wellington, IJ., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10611596/

Economic Evaluation of a Bioinductive Implant for the ... Results. Over a 1-year time horizon, healed lesions were 90.70% and 72.90% for surgical repair of RCTs with and without REGENETEN, respectively.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058274624004488

Bioinductive patch as an augmentation for rotator cuff ... The overall complication rate with the bioinductive patch was 15.5% across all full-thickness RCR studies and 16.2% in partial thickness RCR. We found overall ...

3. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(24)00448-8/abstract

Bioinductive patch as an augmentation for rotator cuff ... The bioinductive collagen patch appears to be a safe augmentation for rotator cuff repair. Patients are likely to experience significant subjective improvement.

4. wexnermedical.osu.edu wexnermedical.osu.edu/departments/innovations/orthopedics/regeneten

Clinical Trial Tests Regeneten Patch in Shoulder ... If the Regeneten implant could help improve healing of the subscapularis, it might improve overall outcomes for many patients, and help prevent the need for ...

5. researchgate.net researchgate.net/publication/388424586_The_Clinical_Efficacy_of_the_Regeneten_Bioinductive_Implant_in_Rotator_Cuff_Repair_A_Systematic_Review

The Clinical Efficacy of the Regeneten Bioinductive Implant ... The implant use resulted in retear rates of 0% up to 18% after 5 years in PT tears and 0% up to 35% after 2 years in FT tears. In 1 randomised ...

6. conmed.com conmed.com/-/media/conmed/documents/clinical/retrospectivechartreviewtoevaluateclinicaloutcomesofbiobrace_whitepaper.ashx

Retrospective Chart Review to Evaluate Clinical Outcomes ... Medical records were reviewed with outcomes documented in 267 patients from four surgeons across four different United. States health care facilities who ...

7. conmed.com conmed.com/en/data-repository

Clinical Data Repository A Retrospective Chart Review was undertaken to evaluate safety and clinical outcomes of the BioBrace® Implant across various applications. ... outcomes of using ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05487677

Subscapularis Repair Augmentation for Total Shoulder ... The investigators would like to learn if subscapularis repair augmentation with the Biobrace in total shoulder arthroplasty (reverse and anatomic) will result ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31150274/

Evaluation of Healing Rates and Safety With a Bioinductive ... Arthroscopic application of this bioinductive collagen scaffold when combined with rotator cuff repair is a safe and effective treatment for healing of large ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38942225/

Bioinductive patch as an augmentation for rotator cuff ... The bioinductive collagen patch appears to be a safe augmentation for rotator cuff repair. Patients are likely to experience significant subjective improvement.