NCT07584356

Brief Summary

The purpose of this study is to determine if patients undergoing anatomic total shoulder arthroplasty (aTSA) will have improved patient reported outcome scores at 1 year compared to those undergoing reverse total shoulder arthroplasty (rTSA).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
42mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

May 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

3 years

First QC Date

May 7, 2026

Last Update Submit

May 7, 2026

Conditions

Shoulder Arthritis

Outcome Measures

Primary Outcomes (1)

  • American Shoulder and Elbow Surgeons (ASES) Questionnaire score

    The American Shoulder and Elbow Surgeons (ASES) score is a self-report survey consisting of a pain scale and activities of daily living section. Total scores range from 0 to 100, where higher scores indicate better shoulder function and less pain.

    1 year

Secondary Outcomes (6)

  • Change in Visual Analog Scale (VAS) Score

    Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months

  • Change in Single Assessment Numeric Evaluation (SANE) Score

    Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months

  • Change in American Shoulder and Elbow Surgeons (ASES) Questionnaire score

    Baseline, 6 weeks, 3 months, 6 months, 24 months

  • Change in Shoulder Subjective Value (SSV) Score

    Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months

  • Change in Activities of Daily Living in External Rotation (ADLER) score

    Baseline, 1 year

  • +1 more secondary outcomes

Study Arms (2)

Anatomic total shoulder arthroplasty (aTSA)

OTHER
Procedure: aTSA

Reverse total shoulder arthroplasty (rTSA)

OTHER
Procedure: rTSA

Interventions

aTSAPROCEDURE

Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo anatomic total shoulder arthroplasty (aTSA) procedure.

Also known as: Anatomic total shoulder arthroplasty
Anatomic total shoulder arthroplasty (aTSA)
rTSAPROCEDURE

Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo reverse total shoulder arthroplasty (rTSA) procedure.

Also known as: Reverse total shoulder arthroplasty
Reverse total shoulder arthroplasty (rTSA)

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Shoulder arthritis
  • Intact rotator cuff
  • Glenoid retroversion less than 25°

You may not qualify if:

  • Rotator cuff insufficiency
  • Fracture deformity/sequelae
  • Severe glenoid deformity (C glenoid, severe A2, B2 glenoid)
  • Current or previous infection of shoulder
  • Previous acromion fracture (not os acromiale)
  • Brachial plexopathy
  • Axillary neuropathy
  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
  • Medical conditions that would make 2 years follow up unlikely
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Jonathan D. Barlow, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noelle M Drapeau, CCRP

CONTACT

507-266-6397drapeau.noelle2@mayo.edu

Xavier C Gendry

CONTACT

507-266-0687gendry.xavier@mayo.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
Principal Investigator

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 13, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)