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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04349319
Enrollment
60
Registered
2020-04-16
Start date
2017-10-01
Completion date
2025-03-31
Last updated
2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Humerus Fracture

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.

Interventions

DEVICEDigital preoperative planning

Before the osteosynthesis of distal humerus fracture, we perform digital preoperative planning.

Sponsors

Tokyo Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A case control study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Distal humerus fracture patients

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Reduction shape1 yearReduction shape parameter
Implant placement1 yearImplant placement parametes

Countries

Japan

Contacts

Primary ContactYuichi Yoshii
yy12721@yahoo.co.jp81298871161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026