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

Tokyo Medical University

Status: Enrolling

Conditions: Distal Humerus Fracture

Treatments: Device: Digital preoperative planning

Study type: Interventional

Funder types: Other

Identifiers

NCT04349319

14-21(distal humerus)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Distal humerus fracture patients

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Digital preoperative planning

Other group

Description:

To use digital preoperative planning software

Treatment:

Device: Digital preoperative planning