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

Distal Humerus Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04349319
• Other study ID #: 14-21(distal humerus)
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: March 2025

Study information

• Verified date: April 2022
• Source: Tokyo Medical University
• Contact: Yuichi Yoshii
• Phone: 81298871161
• Email: yy12721[@]yahoo.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Distal humerus fracture patients

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Distal Humerus Fracture
• Fractures, Bone
• Humeral Fractures

Intervention

Device:
• Digital preoperative planning
Before the osteosynthesis of distal humerus fracture, we perform digital preoperative planning.

Locations

Country	Name	City	State
Japan	Tokyo Medical University Ibaraki Medical Center	Ami	Ibaraki

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction shape	Reduction shape parameter	1 year
Primary	Implant placement	Implant placement parametes	1 year