Development of Three Dimensional Preoperative Planning System for the Osteosynthesis of Distal Humerus Fractures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tokyo Medical University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Reduction shape
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Distal humerus fracture patients
Exclusion Criteria
- •Patients with a previous history of traumatic injuries to the elbow
Arms & Interventions
Digital preoperative planning
To use digital preoperative planning software
Intervention: Digital preoperative planning (Device)
Outcomes
Primary Outcomes
Reduction shape
Time Frame: 1 year
Reduction shape parameter
Implant placement
Time Frame: 1 year
Implant placement parametes
Secondary Outcomes
No secondary outcomes reported
Investigators
Yuichi Yoshii
Associate Professor, Department of Orthopaedic Surgery
Tokyo Medical University