NCT07545707

Brief Summary

The current prospective single-center study is designed to examine an approach that utilizes both high-resolution CT and MRI scans, coupled with customized finite element modelling to analyze the stress placed on the acromion of patients who have undergone RSA surgery. The degree of rotator cuff deficiency will be assessed using Goutallier classification and quantified as Cuff Deficiency Index (CDI), which directly provides biomechanical information for calculating deltoid forces used in finite element analysis. Von Mises stresses in specific acromion zones defined by Levy et al. will then be analyzed.

Trial Health

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Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
9mo left

Started Jun 2026

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

April 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2026

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2027

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 15, 2026

Last Update Submit

April 15, 2026

Conditions

Rotator Cuff InjuriesShoulder Fractures

Keywords

reverse shoulder arthroplastyfinite element analysisacromial fracturerotator cuffbiomechanics

Outcome Measures

Primary Outcomes (1)

  • Regional von Mises stress within acromial Levy zones

    95th percentile of von Mises stress extracted from patient-specific finite element models within anatomically defined Levy classification zones of the acromion

    6 months post-surgery

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive elective RSA candidates at a single orthopaedic centre

You may qualify if:

  • Adult patients (60-85 years) with cuff tear arthropathy (Hamada grade 3 or above, Walch glenoid B/C) scheduled for primary unilateral reverse shoulder arthroplasty
  • Availability of preoperative high-resolution CT (voxel 1 mm or less) and 1.5T/3T MRI
  • Written informed consent for prospective use of anonymised data

You may not qualify if:

  • Revision RSA or history of prior shoulder prosthetic complications
  • Uncorrectable imaging artefacts
  • Post-RSA follow-up shorter than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Molise

Campobasso, CB, 86100, Italy

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesShoulder Fractures

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesFractures, Bone

Central Study Contacts

Emanuele Zappia, PhD candidate

CONTACT

+39 0874 404100e.zappia@studenti.unimol.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate, Biomedical Engineer

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 22, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

March 5, 2027

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)