NCT07464977

Brief Summary

Reverse total shoulder arthroplasty (RTSA) is a well-established method to treat patients with irreparable rotator cuff tears and glenohumeral osteoarthritis. The biomechanical principle implies a medialization and distalization of the center of rotation (COR). Deficiencies in internal and external rotation constitute frequently encountered functional problems. Some studies showed reduced activation of the posterior deltoid in EMG measurements, which may explain the inability to compensate these movements. Lateralized prosthetic designs demonstrated increased external rotation through an alteration of the deltoid's lever arm. The aim of the study is to investigate the impact of lateralization on functional outcome and deltoid EMG activity in comparison to a standard implantation technique.

Trial Health

63
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Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Jun 2026

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

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Study Timeline

Key milestones and dates

Study Progress12%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

August 10, 2024

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

August 10, 2024

Last Update Submit

May 2, 2026

Conditions

Cuff Tear ArthropathyOmarthrosisRotator Cuff Tear Arthropathy

Keywords

reverse total shoulder arthroplastycuff tear arthropathylateralizationdeltoid functionEMG

Outcome Measures

Primary Outcomes (5)

  • Delta Muscle activity (especially posterior Delta part)

    The ratio between peak torque and EMG root mean square is measured

    preoperative

  • Delta Muscle activity (especially posterior Delta part)

    The ratio between peak torque and EMG root mean square is measured

    6 weeks postoperative

  • Delta Muscle activity (especially posterior Delta part)

    The ratio between peak torque and EMG root mean square is measured

    3 months postoperative

  • Delta Muscle activity (especially posterior Delta part)

    The ratio between peak torque and EMG root mean square is measured

    6 months postoperative

  • Delta Muscle activity (especially posterior Delta part)

    The ratio between peak torque and EMG root mean square is measured

    1 year postoperative

Secondary Outcomes (11)

  • Range of movement (forward flexion, abduction, external rotation, extension)

    preoperative

  • Range of movement (forward flexion, abduction, external rotation, extension)

    6 weeks postoperative

  • Range of movement (forward flexion, abduction, external rotation, extension)

    3 months postoperative

  • Range of movement (forward flexion, abduction, external rotation, extension)

    6 months postoperative

  • Range of movement (forward flexion, abduction, external rotation, extension)

    1 year postoperative

  • +6 more secondary outcomes

Study Arms (2)

Standard Implantation Group

ACTIVE COMPARATOR

Subjects treated with a standard glenoid component of the used reverse total shoulder prosthesis

Device: Standard implantation technique

Lateralized Implantation Group

ACTIVE COMPARATOR

Subjects treated with a lateralized glenoid component of the used reverse total shoulder prosthesis

Device: Lateralization of glenoid component

Interventions

Lateralization of glenoid componentDEVICE

Lateralization of glenoid component in reverse total shoulder arthroplasty via metal augment on the glenoid side with a thickness of at least 4mm

Lateralized Implantation Group
Standard implantation techniqueDEVICE

Implantation of a standard glenoid component without any lateralization via metal back on the glenoid site

Standard Implantation Group

Eligibility Criteria

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

You may qualify if:

  • male/female, 60-85y
  • diagnosis of Cuff tear arthropathy (CTA)
  • irreparable rotator cuff tear
  • severe osteoarthritis (OA)
  • primary RSA
  • verified rotator cuff tear in preoperative MRI
  • absence of severe cognitive impairment

You may not qualify if:

  • previous muscle transfer
  • revision surgery
  • highly dysplastic glenoid
  • axillary nerve palsy
  • upper limb radiculopathy
  • cervical myelopathy
  • degenerative muscular disease,
  • previous proximal humeral fracture
  • revision arthroplasty
  • rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik Donaustadt

Vienna, Austria, 1220, Austria

Location

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

ChondrocalcinosisArthritisJoint DiseasesMusculoskeletal DiseasesCrystal Arthropathies

Study Officials

  • Robert Breuer, MD

    Vienna HA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Breuer, MD

CONTACT

00430128802robert.breuer@meduniwien.ac.at

Valentin Pichler, MD

CONTACT

00430128802valentin.pichler@gesundheitsverbund.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2024

First Posted

March 11, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)