Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05344898

Subscap Reverse Shoulder Arthroplasty

The subscapularis is part of the rotator cuff and is release as part of a reverse shoulder replacement. The decision to repair this tendon is controversial. This research is being done to help determine if rotator cuff repair improves or hinders shoulder replacement. A worrisome but rare complication after shoulder replacement is dislocation. Rotator cuff repair may help reduce this risk. The repair may hinder some of the range of motion afterwards or could help with internal rotation strength. There is a chance that the repair doesn't matter at all. The goal of this study is to delineate outcomes after reverse shoulder arthroplasty with the respect to management of the subscapularis tendon. Further information about rotator cuff repair after reverse shoulder replacement can help define complications, potentially decrease OR time, and improve functional outcomes. A total of 148 patients will be enrolled and the duration of the study will be 5 years. All patients will be required to follow-up at 2¬-week, 6-week, 3-month, 6-month, 1-year, and 2-year post-operative marks. Any time information is collected for a study there is a small risk of breach of confidentiality. There are no monetary costs or payments associated with this study. You may or may not benefit by taking part in this study. There is no guarantee that you will receive direct benefit from your participation in this study. To be clear, participation in this study is completely voluntary.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Shoulder Injuries Rotator Cuff Injuries Rupture Tendon Injuries Wounds and Injuries

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

You're going to undergo a procedure called a reverse shoulder replacement and I'm sure Dr. Gilotra already went over the procedure with you but I will again briefly. Before the hardware is put in, there is a tendon in your shoulder that has to be "released". It's released because the doctor has to move it out of the way to get to your shoulder joint. Now when the hardware has been implanted and the surgery is complete, the doctor now has two options. He can decide to repair this tendon or not. The thing is due to the hardware that is implanted, your shoulder doesn't really need this tendon anymore to help it move. So, there are some doctors in the country who choose to repair the tendon and there are some doctors who choose to just let it be. Patients have done great with either or.

We are performing this nationwide study to see if one option (between repairing this tendon or leaving it) is slightly better than the other. There is a chance that repairing the tendon can decrease the risk of dislocations in the future and also help you move your arm better. There is a chance that this repair doesn't matter at all. If we figure out whether to repair or not to repair this tendon, we will be able to better define complications, potentially decrease surgery time, and improve how well patients perform daily activities.

We randomize you to the repair on don't repair group, almost like flipping a coin. With me, you'll be answering simple questions that will track your functionality over time.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 to 95 years old
  • Undergoing reverse shoulder arthroplasty for any indication including revision surgery

Exclusion criteria

  • Irreparable Subscapularis Tendon

a. Reparability of Subscapularis will be determined based on MRI or CT scan obtained preoperatively and confirmed intraoperatively. Tendons must be intact with less than Grade I or II Fatty Infiltration as determined by the Goutallier classification.

  • Any history of proximal humerus fracture
  • Any revision with proximal humerus bone loss

Treatment and study plan

Subscap Tenotomy

Procedure

Group will not have their subscapularis tendon repaired following a reverse shoulder replacement.

Subscap Repair

Procedure

Group will have their subscapularis tendon repaired following a reverse shoulder replacement.

Primary outcomes

  1. Change in Internal Rotation

    Time frame: Pre-op and post-op Months 3,6,12,24

    Internal rotation behind the back

  2. Change in BOSS Scores

    Time frame: Pre-op and post-op Months 3,6,12,24

    Change in Baltimore Orthopaedic Subscapularis Score (BOSS) over 2 years. The score asks enrolled patients a series of questions. The answer choices are the following: No difficulty, mild difficulty, severe difficulty, unable to perform.

Secondary outcomes

  1. Change in ASES score

    Time frame: Pre-op and post-op Months 3,6,12,24

    Change in American Shoulder and Elbow Surgeon (ASES) score over 2 years postoperatively compared to preoperative. The score ranges from 0 to 10 with 0 indicating no pain and 10 indicating worst pain possible.

Other outcomes

  1. Ultrasound Evaluation

    Time frame: Month 6

    Blinded ultrasound evaluation of subscapularis integrity at 6 months. The "Sugaya classification" will be used to assess the subscapularis integrity. The score ranges from Type 1 to Type 5.

    Type 1: indicating sufficient thickness with homogeneously low intensity

    Type 2: sufficient thickness with partial high intensity

    Type 3: insufficient thickness without discontinuity

    Type 4: the presence of a minor discontinuity

    Type 5: the presence of a major discontinuity

Study contacts

Contact information is provided by the study sponsor or research team.

Mohit Gilotra, MD

CONTACT

[email protected]

3015024102

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

Subscapularis Repair in Reverse Shoulder Arthroplasty: A Multi-Center Randomized Single Blinded Superiority Study

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.