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NCT03427112

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

Completed Last updated 1 April 2021
What this trial tests

trial testing Xin1 Humerus System in Proximal Humeral Fracture in 11 participants. Completed in 6 March 2020.

Timeline
4 April 2017
Primary endpoint
6 March 2020
6 March 2020

Quick facts

Lead sponsorAO Research Institute Davos
StatusCompleted
Study typeOBSERVATIONAL
Enrollment11
Start date4 April 2017
Primary completion6 March 2020
Estimated completion6 March 2020
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

AO Research Institute Davos

Who can join

18 and older, any sex, with Proximal Humeral Fracture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Generic Implant Positioning Technology Based on Hole Projections in X-Ray Images.
    Windolf M, Richards RG. · · 2021 · cited 5× · PMID 33995756 · DOI 10.1115/1.4049979
  2. In Vitro Testing and Clinical Handling of a Novel Implant Positioning Technology for Proximal Humeral Plating.
    Windolf M, Knierzinger D, Nijs S, Sermon A, et al · · 2023 · PMID 36984451 · DOI 10.3390/medicina59030450

Verify or expand the search:

Other recruiting trials for Proximal Humeral Fracture

Currently open trials in the same condition.

Other AO Research Institute Davos trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03427112.

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