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OpenTrials
Completed

NCT Number: NCT05083728

S-32 PG 242 Short Stem

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SSM Health- DePaul

Bridgeton, Missouri, 63044, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

CT

Diagnostic Test

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.

Primary outcomes

  1. 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.

    Time frame: <24 hours

    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

Sponsors and collaborators

Lead sponsor

St. Louis Joint Replacement Institute

Other

Collaborators

  • Lima Corporation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2021
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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