NCT05344898

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Nov 2022May 2027

First Submitted

Initial submission to the registry

April 6, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

4.5 years

First QC Date

April 6, 2022

Last Update Submit

July 8, 2026

Conditions

Shoulder InjuriesRotator Cuff Injuries

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Change in ASES score

    Pre-op and post-op Months 3,6,12,24

Other Outcomes (1)

  • Ultrasound Evaluation

    Month 6

Study Arms (2)

Subscap Tenotomy

EXPERIMENTAL

The subscapularis tendon is not repaired.

Procedure: Subscap Tenotomy

Subscap Repair

EXPERIMENTAL

The subscapularis tendon is repaired.

Procedure: Subscap Repair

Interventions

Subscap TenotomyPROCEDURE

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

Subscap Tenotomy
Subscap RepairPROCEDURE

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

Subscap Repair

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (9)

  • 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.

    PMID: 28034540BACKGROUND

  • 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.

    PMID: 28277259BACKGROUND

  • 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.

    PMID: 26796602BACKGROUND

  • 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.

    PMID: 27751722BACKGROUND

  • 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.

    PMID: 28162886BACKGROUND

  • 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.

    PMID: 27566617BACKGROUND

  • 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.

    PMID: 28005111BACKGROUND

  • 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.

    PMID: 2281232BACKGROUND

  • 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.

    PMID: 23268518BACKGROUND

MeSH Terms

Conditions

Shoulder InjuriesRotator Cuff Injuries

Condition Hierarchy (Ancestors)

Wounds and InjuriesRuptureTendon Injuries

Study Officials

  • Mohit Gilotra, MD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohit Gilotra, MD

CONTACT

3015024102mgilotra@som.umaryland.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 25, 2022

Study Start

November 15, 2022

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

May 15, 2027

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)