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S-32 PG 242 Short Stem

NCT05083728 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2025-05-15

No results posted yet for this study

Summary

The data of calibrated CT-scans will be used for the Finite Element Analysis (FEA) analysis for SMR Short Stem in identified hospitals in EU and US as developers of the project and for further research, upon subject acceptance.

In particular, the Quantitative Computer Tomography (QTC)/Finite Element Analysis (FEA) model of the assembly consisting of the shoulder and the orthopaedic implant allows detailed analyses including:

* assessment of micromotion at the bone-implant interface, to predict osseointegration;
* comparison of strains/stresses between the intact bone tissue and the bone with the implant in order to predict the stress shielding phenomenon.

Conditions

Interventions

DIAGNOSTIC_TEST

CT

Clinicians are free to choose the adult subjects in whom a non-contrast calibrated CT-scan will be performed as a part of routine clinical care. The decision to order a noncontrast CT-scan of the shoulder must be made prior to, and independently from, the decision to enroll the patient.

Sponsors & Collaborators

  • Lima Corporation

    collaborator UNKNOWN

  • St. Louis Joint Replacement Institute

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-07-26
Completion
2023-07-26

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05083728 on ClinicalTrials.gov