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

Trial Summary

What is the purpose of this trial?

The primary purpose of this research is to compare the images obtained by ultrasound between a standard repair of the subscapularis tissue and after repair with a Biobrace. The secondary purpose is to determine if there are any clinical differences.

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 data supports the effectiveness of the treatment Pitch Patch Augmentation and similar techniques for shoulder injuries?

Research suggests that augmenting subscapularis repair, such as using the long head of the biceps tendon, can provide additional structural support and improve outcomes by preventing repair failure. Techniques like the 'Biceps-Subscap Sling' offer a cost-effective and biologically active option to enhance repair strength and stability. ^{1 2 3 4 5}

Is subscapularis repair generally safe for humans?

The available research does not specifically address the safety of subscapularis repair techniques, but it discusses various methods and improvements aimed at enhancing repair integrity and outcomes. These studies focus on improving the repair process and outcomes, suggesting that the techniques are considered safe enough to be used and studied in clinical settings. ^{3 4 5 6 7}

How does the Pitch Patch Augmentation treatment for subscapularis repair differ from other treatments?

The Pitch Patch Augmentation treatment for subscapularis repair is unique because it uses a patch to support the tendon repair, which may provide additional strength and stability compared to traditional suture-based repairs. This approach is different from other methods like subscapularis tenotomy or osteotomy, which focus on different surgical techniques without the use of a patch. ^{1 4 5 8 9}

Research Team

Michael Freehill, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

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

Comparison of Subscapularis Management and Repair Techniques. [2021]

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

The Subscapularis-Sparing Approach in Humeral Head Replacement. [2016]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Subscapularis Repair Augmentation With the Long Head Biceps Tendon During Anatomic Total Shoulder Arthroplasty: The "Biceps-Subscap Sling" Technique. [2023]

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

Subscapularis Tears: Evolution in Treatment Options. [2022]

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

Biomechanical Evaluation of the Efficacy of Suture Tape Augmentation for Subscapularis Peel Repair. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A novel technique for subscapularis repair in total shoulder arthroplasty. [2023]

7. United States 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. [2023]

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

Stem-Based Repair of the Subscapularis in Total Shoulder Arthroplasty. [2022]

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

Lesser tuberosity osteotomy and subscapularis tenotomy repair techniques during total shoulder arthroplasty: A meta-analysis of cadaveric studies. [2018]