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Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

Primary Purpose

Shoulder Injuries

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BioBrace Augmentation

Standard Repair with Sutures

About this trial

This is an interventional treatment trial for Shoulder Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Total Shoulder Arthroplasty

Exclusion Criteria:

Vulnerable population

Sites / Locations

Stanford University
Tulane University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BioBrace Augmentation

Standard Repair with Sutures

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Difference in continuity of subscapularis tissue on ultrasound

Continuity of subscapularis tissue on ultrasound

Difference in thickness of the subscapularis tissue on ultrasound

Thickness of subscapularis tissue on ultrasound

Evaluate arthritis on shoulder x-ray

Amount of arthritis or wear patterns on shoulder x-Ray

Difference in signs of loosening or wear patterns in shoulder X-Ray

Signs of loosening or wear patterns on shoulder x-ray

Secondary Outcome Measures

American Shoulder & Elbow Surgeons Score (ASES) score

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

Examining passive range of motion - forward flexion, external rotation, abduction

Shoulder examination for the difference in Active Range of Motion

Examining active range of motion - internal rotation up posterior thorax. Strength- Jobes, external rotation, lift-off and belly-press

Full Information

NCT ID

NCT05487677

First Posted

July 22, 2022

Last Updated

September 11, 2023

Sponsor

Stanford University

Collaborators

Tulane University

1. Study Identification

Unique Protocol Identification Number

NCT05487677

Brief Title

Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

Official Title

Augmentation of Subscapularis Repair in Total Shoulder Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2023 (Anticipated)

Primary Completion Date

September 1, 2025 (Anticipated)

Study Completion Date

March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Tulane University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

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

Detailed Description

The investigators would like to learn if subscapularis repair augmentation with the Biobrace 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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 BioBrace augmentation of the repair.

Masking

ParticipantOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BioBrace Augmentation

Arm Type

Experimental

Arm Description

Arm Title

Standard Repair with Sutures

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

BioBrace Augmentation

Other Intervention Name(s)

Implant Group

Intervention Description

During shoulder replacement surgery, the subscapularis (rotator cuff muscle) is sometimes repaired back again. This will be stitched and augmented with a BioBrace. The Biobrace is a biocomposite scaffold meaning both synthetic and biologic, compared to other traditional implants that are either synthetic or biologic. The stitch in the BioBrace group will be anchored to and reinforced by this material.

Intervention Type

Procedure

Intervention Name(s)

Standard Repair with Sutures

Other Intervention Name(s)

Stitch Group

Intervention Description

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.

Primary Outcome Measure Information:

Title

Difference in continuity of subscapularis tissue on ultrasound

Description

Continuity of subscapularis tissue on ultrasound

Time Frame

6 weeks, 6 months after surgery

Title

Difference in thickness of the subscapularis tissue on ultrasound

Description

Thickness of subscapularis tissue on ultrasound

Time Frame

3 months, 1 years after surgery

Title

Evaluate arthritis on shoulder x-ray

Description

Amount of arthritis or wear patterns on shoulder x-Ray

Time Frame

Surgery

Title

Difference in signs of loosening or wear patterns in shoulder X-Ray

Description

Signs of loosening or wear patterns on shoulder x-ray

Time Frame

2 weeks, 3 months, 6 months, 1 year, 2 years after surgery

Secondary Outcome Measure Information:

Title

American Shoulder & Elbow Surgeons Score (ASES) score

Description

Time Frame

2 weeks, 3 months, 6 months, 1 year, 2 years after surgery

Title

Shoulder examination for the difference in Passive Range of Motion

Description

Examining passive range of motion - forward flexion, external rotation, abduction

Time Frame

2 weeks, 3 months, 6 months, 1 year, 2 years after surgery

Title

Shoulder examination for the difference in Active Range of Motion

Description

Examining active range of motion - internal rotation up posterior thorax. Strength- Jobes, external rotation, lift-off and belly-press

Time Frame

3 months, 6 months, 1 year, 2 years after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Total Shoulder Arthroplasty Exclusion Criteria: Vulnerable population

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elizabeth Jameiro

Phone

650-725-5978

ejameiro@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael T Freehill, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Redwood City

State/Province

California

ZIP/Postal Code

94063

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Ramakrishnan

Phone

650-497-3597

annarama@stanford.edu

First Name & Middle Initial & Last Name & Degree

Michael Freehill, MD

Facility Name

Tulane University

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70118

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mike O'Brien, MD

12. IPD Sharing Statement

Learn more about this trial

Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

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