Back to resultsDevelopment of Three Dimensional Preoperative Planning System for the Osteosynthesis of Distal Humerus Fractures
Primary Purpose
Distal Humerus Fracture
Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Digital preoperative planning
Sponsored by
About this trial
This is an interventional treatment trial for Distal Humerus Fracture
Eligibility Criteria
Inclusion Criteria:
- Distal humerus fracture patients
Exclusion Criteria:
- Patients with a previous history of traumatic injuries to the elbow
Sites / Locations
- Tokyo Medical University Ibaraki Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Digital preoperative planning
Arm Description
To use digital preoperative planning software
Outcomes
Primary Outcome Measures
Reduction shape
Reduction shape parameter
Implant placement
Implant placement parametes
Secondary Outcome Measures
Full Information
NCT ID
NCT04349319
First Posted
April 14, 2020
Last Updated
April 25, 2022
Sponsor
Tokyo Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04349319
Brief Title
Development of Three Dimensional Preoperative Planning System for the Osteosynthesis of Distal Humerus Fractures
Official Title
Development of Three Dimensional Preoperative Planning System for the Osteosynthesis of Distal Humerus Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokyo Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Humerus Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A case control study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digital preoperative planning
Arm Type
Other
Arm Description
To use digital preoperative planning software
Intervention Type
Device
Intervention Name(s)
Digital preoperative planning
Intervention Description
Before the osteosynthesis of distal humerus fracture, we perform digital preoperative planning.
Primary Outcome Measure Information:
Title
Reduction shape
Description
Reduction shape parameter
Time Frame
1 year
Title
Implant placement
Description
Implant placement parametes
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Distal humerus fracture patients
Exclusion Criteria:
Patients with a previous history of traumatic injuries to the elbow
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuichi Yoshii
Phone
81298871161
Email
yy12721@yahoo.co.jp
Facility Information:
Facility Name
Tokyo Medical University Ibaraki Medical Center
City
Ami
State/Province
Ibaraki
ZIP/Postal Code
305-0395
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuichi Yoshii
Phone
81298871161
Email
yy12721@yahoo.co.jp
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Development of Three Dimensional Preoperative Planning System for the Osteosynthesis of Distal Humerus Fractures
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