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

NCT ID: NCT04349319

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Distal Humerus Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A case control study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital preoperative planning

To use digital preoperative planning software

Group Type OTHER

Digital preoperative planning

Intervention Type DEVICE

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

Interventions

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Digital preoperative planning

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Distal humerus fracture patients

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tokyo Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yuichi Yoshii

Associate Professor, Department of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tokyo Medical University Ibaraki Medical Center

Ami, Ibaraki, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Yuichi Yoshii

Role: CONTACT

81298871161

Facility Contacts

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Yuichi Yoshii

Role: primary

81298871161

References

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Yoshii Y, Iwabuchi S, Ikumi A, Kohyama S, Ogawa T, Ishii T. Correlations between 3D preoperative planning and postoperative reduction in the osteosynthesis of distal humeral fractures. J Orthop Surg Res. 2023 Apr 8;18(1):283. doi: 10.1186/s13018-023-03772-y.

Reference Type DERIVED
PMID: 37031170 (View on PubMed)

Other Identifiers

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14-21(distal humerus)

Identifier Type: -

Identifier Source: org_study_id

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