DenCT Shoulder Bone Quality Evaluation

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06032416
Study type	Interventional
Source	Zimmer Biomet
Contact	Elliott Goff, PhD
Phone	41792222308
Email	elliott.goff@zimmerbiomet.com
Status	Not yet recruiting
Phase	N/A
Start date	April 2024
Completion date	April 2026

View Details

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