NCT06292169

Brief Summary

The goal of this clinical trial is to assess if concomitant open pectoralis minor release would improve pain and outcomes after Reverse Shoulder Arthroplasty (RSA). The main questions it aims to answer are:

  • whether releasing the pectoralis minor prophylactically could have better pain relief
  • whether releasing the pectoralis minor prophylactically could have increased Range of motion (ROM) outcomes
  • whether releasing the pectoralis minor prophylactically could have higher final Patient Reported Outcome Measurements (PROMs) Participants will be randomized to either undergo RSA with pectoralis minor release or RSA without pectoralis minor release.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 15, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 7, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

1.4 years

First QC Date

February 15, 2024

Last Update Submit

October 22, 2025

Conditions

Reverse Total Shoulder ArthroplastyRotator Cuff Tear ArthropathyAdvanced Glenohumeral Osteoarthritis

Keywords

Reverse Total Shoulder ArthroplastyReverse Shoulder ArthroplastyAmerican Shoulder and ElbowRange of motionPectoralis Minor

Outcome Measures

Primary Outcomes (1)

  • Visual analog Scale (VAS) pain scores

    The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Study participants will be asked to rate their current level of pain by placing a mark on the line

    Baseline, 6 months

Other Outcomes (7)

  • Visual analog Scale (VAS) pain scores

    Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)

  • American Shoulder and Elbow Score (ASES)

    Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)

  • Subjective Shoulder Value (SSV)

    Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)

  • +4 more other outcomes

Study Arms (2)

RSA with pectoralis minor release

EXPERIMENTAL
Procedure: Pectoralis Minor ReleaseProcedure: RSA

RSA without pectoralis minor release

ACTIVE COMPARATOR
Procedure: RSA

Interventions

Pectoralis Minor ReleasePROCEDURE

The pectoralis minor is a muscle on the anterior chest wall attaching to the coracoid process. In the group undergoing pectoralis minor release, through the same deltopectoral incision that will not be extended or different as compared to the RSA only group, the pec minor will be exposed on the medial aspect of the coracoid at the upper part of the incision. It will be cut from its insertion on the coracoid while being careful to protect any neurovascular structures.

RSA with pectoralis minor release
RSAPROCEDURE

RSA is the current Standard of Care (SOC)

RSA with pectoralis minor releaseRSA without pectoralis minor release

Eligibility Criteria

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

You may qualify if:

  • All patients undergoing surgery for reverse total shoulder arthroplasty
  • Patients willing and able to provide informed consent

You may not qualify if:

  • Revision arthroplasty
  • Reverse shoulder arthroplasty for proximal humerus fractures
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory Clinic

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Healthcare Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

ChondrocalcinosisArthritisJoint DiseasesMusculoskeletal DiseasesCrystal Arthropathies

Study Officials

  • Eric Wagner, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Wagner, MD

CONTACT

404-778-7249eric.r.wagner@emory.edu

Musab Gulzar

CONTACT

201-344-0298mgulzar@emory.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Electronic random number generator Single-blinded (concealed to the study participant only, Investigator blinded not feasible)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 15, 2024

First Posted

March 5, 2024

Study Start

August 7, 2024

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

October 23, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)