Subscap Reverse Shoulder Arthroplasty

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Injuries; Shoulder Injuries
• Intervention / Treatment: Procedure: Subscap Tenotomy; Procedure: Subscap Repair

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohit Gilotra, MD; Phone Number: 3015024102; Email: mgilotra@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland School of Medicine
      • Contact: Kevin K Wendeu-Foyet, B.S; Phone Number: 301-978-1431; Email: kevinwendeufoyet@gmail.com
      • Contact: Mohit N Gilotra, M.D./M.S.; Phone Number: 3015024102; Email: MGilotra@som.umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 18 to 95 years old
2. Undergoing reverse shoulder arthroplasty for any indication including revision surgery

Exclusion Criteria:

1. 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.

2. Any history of proximal humerus fracture
3. Any revision with proximal humerus bone loss

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subscap Tenotomy; The subscapularis tendon is not repaired.	Procedure: Subscap Tenotomy; Group will not have their subscapularis tendon repaired following a reverse shoulder replacement.
Experimental: Subscap Repair; The subscapularis tendon is repaired.	Procedure: Subscap Repair; Group will have their subscapularis tendon repaired following a reverse shoulder replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Internal Rotation	Internal rotation behind the back	Pre-op and post-op Months 3,6,12,24
Change in BOSS Scores	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.	Pre-op and post-op Months 3,6,12,24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ASES score	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.	Pre-op and post-op Months 3,6,12,24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound Evaluation	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	Month 6

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Mohit Gilotra, MD, University of Maryland, Baltimore

Publications and helpful links

General Publications

• Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802.
• Farrington CP, Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med. 1990 Dec;9(12):1447-54. doi: 10.1002/sim.4780091208.
• Otto RJ, Clark RE, Frankle MA. Reverse shoulder arthroplasty in patients younger than 55 years: 2- to 12-year follow-up. J Shoulder Elbow Surg. 2017 May;26(5):792-797. doi: 10.1016/j.jse.2016.09.051. Epub 2016 Dec 26.
• Friedman RJ, Flurin PH, Wright TW, Zuckerman JD, Roche CP. Comparison of reverse total shoulder arthroplasty outcomes with and without subscapularis repair. J Shoulder Elbow Surg. 2017 Apr;26(4):662-668. doi: 10.1016/j.jse.2016.09.027. Epub 2016 Oct 27.
• Villacis D, Sivasundaram L, Pannell WC, Heckmann N, Omid R, Hatch GF 3rd. Complication rate and implant survival for reverse shoulder arthroplasty versus total shoulder arthroplasty: results during the initial 2 years. J Shoulder Elbow Surg. 2016 Jun;25(6):927-35. doi: 10.1016/j.jse.2015.10.012. Epub 2016 Jan 18.
• Vourazeris JD, Wright TW, Struk AM, King JJ, Farmer KW. Primary reverse total shoulder arthroplasty outcomes in patients with subscapularis repair versus tenotomy. J Shoulder Elbow Surg. 2017 Mar;26(3):450-457. doi: 10.1016/j.jse.2016.09.017. Epub 2016 Oct 14.
• Kohan EM, Chalmers PN, Salazar D, Keener JD, Yamaguchi K, Chamberlain AM. Dislocation following reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2017 Jul;26(7):1238-1245. doi: 10.1016/j.jse.2016.12.073. Epub 2017 Feb 3.
• Pastor MF, Kraemer M, Wellmann M, Hurschler C, Smith T. Anterior stability of the reverse shoulder arthroplasty depending on implant configuration and rotator cuff condition. Arch Orthop Trauma Surg. 2016 Nov;136(11):1513-1519. doi: 10.1007/s00402-016-2560-3. Epub 2016 Aug 26.
• Padegimas EM, Zmistowski BM, Restrepo C, Abboud JA, Lazarus MD, Ramsey ML, Williams GR, Namdari S. Instability After Reverse Total Shoulder Arthroplasty: Which Patients Dislocate? Am J Orthop (Belle Mead NJ). 2016 Nov/Dec;45(7):E444-E450.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): May 15, 2027

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Rupture; Tendon Injuries; Rotator Cuff Injuries; Shoulder Injuries; Wounds and Injuries
• Other Study ID Numbers: HP-00100825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No