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

Not Applicable

Recruiting

• Conditions: Distal Humerus Fracture
• Interventions: Device: Digital preoperative planning

• Registration Number: NCT04349319
• Lead Sponsor: Tokyo Medical University

Brief 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.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-27
• Primary Completion: 2024-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Distal humerus fracture patients

Exclusion Criteria

• Patients with a previous history of traumatic injuries to the elbow

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digital preoperative planning	Digital preoperative planning	To use digital preoperative planning software

Primary Outcome Measures

Name	Time	Method
Implant placement	1 year	Implant placement parametes
Reduction shape	1 year	Reduction shape parameter

Trial Locations

Locations (1)

Tokyo Medical University Ibaraki Medical Center; 🇯🇵 Ami, Ibaraki, Japan