MedTrace Logo

Assessment of the Surgical Handling and Performance of the X-ray-based Tracking and Navigation System "Xin1 Humerus System" Evaluated From 10 Proximal Humerus Plate Fixations

NCT03427112 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2021-04-01

No results posted yet for this study

Summary

Xin1 Humerus system is an X-ray-based tracking and navigation system designed to calculate the plate position and all required proximal screw lengths for proximal humerus plate fixation. The aim is to validate the system performance in a clinical context and test the surgical handling of the Xin1 marker in a hospital environment. 10 adults having sustained a proximal humerus fracture and are indicated for plate fixation osteosynthesis will be provided intraoperatively with the Xin1 marker. The system performance is evaluated retrospectively by post-processing the intraoperative X-ray images after surgery

Conditions

  • Proximal Humeral Fracture

Interventions

DEVICE

Xin1 Humerus System

Retrospective assessment of the surgical handling and performance of the X-ray-based tracking and navigation system "Xin1 Humerus system" evaluated from 10 proximal humerus plate fixations

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • AO Research Institute Davos

    lead OTHER

Principal Investigators

  • Stefaan Nijs, Prof. · UZ Leuven campus Gasthuisberg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-04
Primary Completion
2020-03-06
Completion
2020-03-06
FDA Device
Yes

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03427112 on ClinicalTrials.gov