Three Dimensional Digital Preoperative Planning for the Osteosynthesis of Distal Radius Fractures
1 other identifier
interventional
100
1 country
1
Brief Summary
Background: Three dimensional (3D) digital pre-operative planning software for osteosynthesis of fractures was developed. To assess the usefulness of the 3D planning, we evaluated the accuracy of the reduction shapes and selected implants in the patients with distal radius fractures. Methods: Thirty wrists of 30 distal radius fracture patients who underwent osteosynthesis using volar locking plates were evaluated. Fifteen wrists were treated with 3D preoperative planning as the plan group. The other fifteen wrists were treated with conventional preoperative planning as the control group. Volar tilt and radial inclination were measured after operation and compared with the healthy side wrist. In addition, preoperative planning and postoperative reductions were compared by measuring the volar tilt and radial inclination of the 3D images in the plan group. The intra-class correlation coefficient (ICC) values of the radiological parameters between healthy side wrists and injured side wrists, between preoperative planning and postoperative reductions were evaluated. For the accuracy of the implant choices, the ICCs for the screw lengths between the preoperative plan and the actual choices were evaluated in the plan group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 14, 2016
CompletedFirst Posted
Study publicly available on registry
September 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedApril 27, 2022
April 1, 2022
10.3 years
September 14, 2016
April 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Intraclass correlation coefficients between preoperative plan and after surgery
An intra-class correlation coefficient (ICC) was used to evaluate the accuracy of the anatomical reduction. The ICC values of the radiological parameters (volar tilt and radial inclination) between healthy side wrists and injured side wrists after the surgery were evaluated in both the plan and control groups. In addition, the ICCs of the 3D measurements between the pre-operative plan and the post-operative 3D images were evaluated in the plan group.
1 week
Study Arms (2)
Plan group
ACTIVE COMPARATOR3D preoperative planning for the distal radius fracture was performed prior to the osteosynthesis.
Control group
ACTIVE COMPARATORConventional preoperative planning for the distal radius fracture was performed prior to the osteosynthesis.
Interventions
preoperative planning using 3D digital planning software or conventional template
Eligibility Criteria
You may qualify if:
- the patients who have distal radius fracture in their unilateral wrist.
You may not qualify if:
- the patients who reported a previous history of traumatic injuries to the arm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tokyo Medical University Ibaraki Medical Center
Ami, Ibaraki, 300-0395, Japan
Related Publications (1)
Yoshii Y, Ogawa T, Shigi A, Oka K, Murase T, Ishii T. Three-dimensional evaluations of preoperative planning reproducibility for the osteosynthesis of distal radius fractures. J Orthop Surg Res. 2021 Feb 12;16(1):131. doi: 10.1186/s13018-021-02278-9.
PMID: 33579338DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuichi Yoshii
Tokyo Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 14, 2016
First Posted
September 21, 2016
Study Start
January 1, 2014
Primary Completion
May 1, 2024
Study Completion
May 1, 2025
Last Updated
April 27, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share