NCT06032416

DenCT Shoulder Bone Quality Evaluation

Collection of CT Images to Evaluate Bone Quality Before Total Shoulder Arthroplasty

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to evaluate the preoperative bone quality assessment based on CT to later establish a scale for the decision of stemless shoulder arthroplasty.

Detailed description

The primary endpoint is the collection of the preoperative CT scan with a calibration phantom at each site and the surgeon's intraoperative evaluation of bone quality. Therefore, this study is not centered around a specific device and any primary shoulder arthroplasty system from Zimmer Biomet including anatomical, hemi, or reverse, stemmed or stemless configurations can be used for the target population. The indications of this study are the shoulder joint diseases such as osteoarthritis and the irreparable rotator cuff tears which are needed with TSA/RSA. The subjects should be also met the inclusion/exclusion criteria. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.

Conditions

• Osteoarthritis Shoulder
• Rotator Cuff Tears

Interventions

Type	Name	Description
RADIATION	Preoperative CT Scan	Preoperative CT Scan including a bone density calibration phantom. This data will be compared with surgeon intra-operative CRF responses.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2023-09-13
• Last updated: 2025-02-10

Locations

1 site across 1 country: Japan