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Clinical Trial Summary

This study is a multicenter, prospective, non-randomized, non-controlled post-market clinical follow-up study. The primary objective of this study is to confirm the safety and performance of the A.L.P.S. Proximal Humerus Plating System applied in proximal humerus fracture treatment.


Clinical Trial Description

The A.L.P.S. Proximal Humerus Plating System was developed to provide another surgical option for proximal humerus fracture fixation. The aim of the A.L.P.S. Proximal Humerus Plating System is to provide increased fracture stability while simultaneously increasing range of motion and decreasing the likelihood of screw perforation. A minimum of 7 and maximum of 10 sites globally will be involved in this study. This number of clinical sites will allow for a better generalization of study data as well as allow for consistency to be developed across multiple regions. 135 implants will be included into the study. Each site will be allowed to enroll 27 humeri. Enrollment is competitive. All potential study subjects will be required to participate in the Informed Consent process. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03626038
Study type Interventional
Source Zimmer Biomet
Contact Kim Blick, BSBM
Phone 352-233-0866
Email kim.blick@zimmerbiomet.com
Status Recruiting
Phase N/A
Start date June 19, 2018
Completion date July 2024

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