S-32 PG 242 Short Stem

NCT05083728 | Completed

• 1 other identifier: 21-06-2182
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Osteoporosis

Outcome Measures

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

  <24 hours

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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;

Sponsors & Collaborators

• St. Louis Joint Replacement Institute: lead
• Lima Corporation: collaborator

Study Sites (1)

SSM Health- DePaul

Bridgeton, Missouri, 63044, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: November 1, 2021
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: May 15, 2025

Record last verified: 2021-11

Locations

US (1)