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A.L.P.S. Proximal Humerus Plating System Post-Market Clinical Follow-up Study
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Foundation for Orthopaedic Research & Education
Tampa, Florida, United States
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia
The Research Institute of McGill University Health Centre
Montreal, Quebec, Canada
Korea University Anam Hospital
Seoul, Seoul, South Korea
Hallym University Kangnam Sacred Hearth Hospital
Seoul, Seoul, South Korea
Inje University Seoul Paik Hospital
Seoul, Seoul, South Korea
Bone and Motion Training and Research Foundation
Granges-Paccot, Granges-Paccot, Switzerland
Start Date
June 19, 2018
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2026
Last Updated
February 13, 2026
135
ACTUAL participants
A.L.P.S. Proximal Humerus Plating System
DEVICE
Lead Sponsor
Zimmer Biomet
NCT07153471
NCT07484243
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06647069