S-32 PG 242 Short Stem

Osteoporosis Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05083728
• Other study ID #: 21-06-2182
• Status: Not yet recruiting
• Start date: November 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: October 2021
• Source: St. Louis Joint Replacement Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: March 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
St. Louis Joint Replacement Institute	Lima Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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