Subscapularis Repair Patch Augmentation for Total Shoulder Arthroplasty

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05487677

Collaborator

Tulane University (Other)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 patch. The secondary purpose is to determine if there are any clinical differences.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Injuries	Procedure: Pitch Patch Augmentation Procedure: Standard Repair with Sutures	N/A

Detailed Description

The investigators would like to learn if subscapularis repair augmentation with the Pitch Patch in total shoulder arthroplasty (reverse and anatomic) will result in sonographic and/or clinical improvements. This will allow for improvements in technique and better outcomes for patients going forward.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients undergoing reverse shoulder arthroplasty will be recruited, consented, & enrolled. Patient will be randomized to standard repair with sutures versus standard repair with patch augmentation of the repair.Patients undergoing reverse shoulder arthroplasty will be recruited, consented, & enrolled. Patient will be randomized to standard repair with sutures versus standard repair with patch augmentation of the repair.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The physician performing the ultrasound evaluation will be blinded to which treatment arm.

Primary Purpose:

Treatment

Official Title:

Augmentation of Subscapularis Repair in Total Shoulder Arthroplasty

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pitch Patch Augmentation 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 patch, patient will receive patch augmentation of the standard subscapularis repair.	Procedure: Pitch Patch Augmentation During shoulder replacement surgery, the subscapularis (rotator cuff muscle) is sometimes repaired back again. This will be stitched and augmented with a patch. The patch consists of a fiber (polyester) mesh. The stitch in the patch group will be anchored to ane reinforced by this material. Other Names: Patch Group
Active Comparator: Standard Repair with Sutures 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.	Procedure: Standard Repair with Sutures During shoulder replacement surgery, the Subscapularis (rotator cuff muscle) is sometimes repaired back again. This is usually repaired with stitches per standard of care treatment. Other Names: Stitch Group

Arm

Intervention/Treatment

Experimental: Pitch Patch Augmentation

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 patch, patient will receive patch augmentation of the standard subscapularis repair.

Procedure: Pitch Patch Augmentation

During shoulder replacement surgery, the subscapularis (rotator cuff muscle) is sometimes repaired back again. This will be stitched and augmented with a patch. The patch consists of a fiber (polyester) mesh. The stitch in the patch group will be anchored to ane reinforced by this material.

Other Names:

Patch Group

Active Comparator: Standard Repair with Sutures

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.

Procedure: Standard Repair with Sutures

During shoulder replacement surgery, the Subscapularis (rotator cuff muscle) is sometimes repaired back again. This is usually repaired with stitches per standard of care treatment.

Other Names:

Stitch Group

Outcome Measures

Primary Outcome Measures

Difference in continuity of subscapularis tissue on ultrasound [3 months, 1 years after surgery]
Continuity of subscapularis tissue on ultrasound
Difference in thickness of the subscapularis tissue on ultrasound [3 months, 1 years after surgery]
Thickness of subscapularis tissue on ultrasound
Evaluate arthritis on shoulder x-ray [Surgery]
Amount of arthritis or wear patterns on shoulder x-Ray
Difference in signs of loosening or wear patterns in shoulder X-Ray [2 weeks, 3 months, 6 months, 1 year, 2 years after surgery]
Signs of loosening or wear patterns on shoulder x-ray

Secondary Outcome Measures

American Shoulder & Elbow Surgeons Score (ASES) score [2 weeks, 3 months, 6 months, 1 year, 2 years after surgery]
is a 100-point scale that consists of two dimensions: pain and activities of daily living. 0 indicates worse shoulder condition and 100 indicates best shoulder condition. The greater the score, the lower the level of shoulder disability
Shoulder examination for the difference in Passive Range of Motion [2 weeks, 3 months, 6 months, 1 year, 2 years after surgery]
Examining passive range of motion - forward flexion, external rotation, abduction
Shoulder examination for the difference in Active Range of Motion [3 months, 6 months, 1 year, 2 years after surgery]
Examining active range of motion - internal rotation up posterior thorax. Strength- Jobes, external rotation, lift-off and belly-press

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Total Shoulder Arthroplasty

Exclusion Criteria:

Vulnerable population

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Redwood City	California	United States	94063
2	Tulane University	New Orleans	Louisiana	United States	70118

Sponsors and Collaborators

Stanford University
Tulane University

Investigators

Principal Investigator: Michael T Freehill, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael T. Freehill, Associate Professor of Orthopaedic Surgery, Stanford University

ClinicalTrials.gov Identifier:

NCT05487677

Other Study ID Numbers:

64618

First Posted:

Aug 4, 2022

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shoulder Injuries

Study Results

No Results Posted as of Aug 4, 2022