S-32 PG 242 Short Stem

An Observational Study of Calibrated CT Scans to Evaluate Shoulder Geometry and Bone Density for Finite Element Analysis (FEA) on a Simulated Surgical Implant

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Diagnostic test: CT

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • SSM Health- DePaul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The eligible patient population for this study will include all patients who require a noncontrast CT as a part of their clinical care. The effective number of cases included will depend on the availability and quality of calibrated CT-scan imaging data necessary to perform FEA as detailed in the selection criteria.

Description

Inclusion Criteria:

• 1. Subjects (males and/or females) must be ≥ 18 years of age

  2. Subjects are willing and able to provide written informed consent for collection of the data; if a patient has already completed and performed the calibrated CT-scans as per standard clinical practice, the subject may be contacted to offer participation in the study.

  3. Adult patients who will undergo noncontrast CT scanning of the shoulder as part of routine preoperative planning for shoulder arthroplasty will be eligible to participate in the study and receive a calibrated CT scan of the shoulder. The decision to undergo CT scan will be made independently of study participation; only patients who require a CT scan of the shoulder for clinically necessary reasons are eligible to participate.

Exclusion Criteria:

• 1. Pregnancy or lactation; 2. Subjects who have fracture of the affected shoulder; 3. Subjects who have had prior surgery on the affected shoulder that resulted in metal implants, including but not limited to:
• Partial or total shoulder joint replacement;
• Open reduction internal fixation of fracture;
• Prior rotator cuff repair with metal implants; 4. Local or systemic infection; 5. Persistent acute or chronic osteomyelitis; 6. Focal vascular or neurologic diseases affecting the concerned limb; 7. Metabolic disorders or systemic diseases that substantially affect bone quality, including the following:
• Renal osteodystrophy
• Osteoporosis
• Osteomalacia
• Osteopetrosis 8. Bone tumors involving the shoulder girdle; 9. Local or disseminated neoplastic diseases; 10. Severe deformity including malunion, nonunion, excessive bone loss that would result in improper virtual implant positioning;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint: Collection of calibrated CT scans to obtain human imaging data to perform a Finite Element Analysis (FEA) on a simulated surgery using a specific implant, as per clinical practice.	To perform the Finite Element Analysis (FEA), the following data will be requested: Shoulder calibrated CT-scan; Date of calibrated CT-scan execution; Subject's year of birth; Subject's sex; Subject's weight; Subject's height; Subject's ethnicity	<24 hours

Collaborators and Investigators

• Sponsor: St. Louis Joint Replacement Institute
• Collaborators: Lima Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): July 26, 2023
• Study Completion (Actual): July 26, 2023

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: 21-06-2182

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No