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Three Dimensional Digital Preoperative Planning for the Osteosynthesis of Distal Radius Fractures

NCT02909647 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-04-27

No results posted yet for this study

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.

Conditions

  • Distal Radius Fracture

Interventions

PROCEDURE

Preoperative planning

preoperative planning using 3D digital planning software or conventional template

PROCEDURE

Osteosynthesis

osteosynthesis using volar locking plate

Sponsors & Collaborators

  • Tokyo Medical University

    lead OTHER

Principal Investigators

  • Yuichi Yoshii · Tokyo Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2024-05-31
Completion
2025-05-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02909647 on ClinicalTrials.gov