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CompletedNCT05083728Updated May 15, 2025

S-32 PG 242 Short Stem

An observational study in Osteoporosis, sponsored by St. Louis Joint Replacement Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.

Sponsored by St. Louis Joint Replacement Institute · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
45
Ages
18 Years and older
Sex
All
01

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.
02

Conditions studied

  • Osteoporosis

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

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

      1. 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.
      1. 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

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;
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testCT

    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.

05

What researchers measure

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.

    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

    Time frame: <24 hours

06

Study locations

1 site
  • SSM Health- DePaul
    Bridgeton, Missouri 63044, United States
07

Registry details

Key details

Study ID
NCT05083728
Lead sponsor
St. Louis Joint Replacement Institute
Collaborators
Lima Corporation
Responsible party
Sponsor
First posted
Oct 19, 2021
Start date
Nov 1, 2021
Primary completion
Jul 26, 2023
Completion
Jul 26, 2023
Last update
May 15, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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