NCT04349319

Development of Three Dimensional Preoperative Planning System for the Osteosynthesis of Distal Humerus Fractures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tokyo Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To reproduce anatomical reduction and appropriate implant placement/choices during osteosynthesis for elbow fractures, a 3D preoperative planning system was developed. To assess the utility of 3D digital preoperative planning for the osteosynthesis of distal humerus fractures, the reproducibility of implant reduction shapes and placements in patients with distal humerus fractures will be evaluated.

Detailed description

3D preoperative planning will be applied for four distal humerus fracture cases . The preoperative planning will be performed in order to determine the reduction, placement and choices of implants. After the operation, the accuracy of the reduction and implants choices and placements will be verified. The reductions will be evaluated with an angle between the diaphysis axis and a line connecting the medial epicondyle with the lateral epicondyle and an angle between the diaphysis axis and the articular surface in the coronal plane and distance between the anterior diaphysis and the anterior articular surface in the sagittal plane for the 3D images of distal humerus. The reproducibility will be evaluated by the differences of the parameters between pre- and post-operative images.

Conditions

• Distal Humerus Fracture

Interventions

Type	Name	Description
DEVICE	Digital preoperative planning	Before the osteosynthesis of distal humerus fracture, we perform digital preoperative planning.

Timeline

• Start date: 2017-10-01
• Primary completion: 2024-03-01
• Completion: 2025-03-01
• First posted: 2020-04-16
• Last updated: 2022-04-27

Locations

1 site across 1 country: Japan