NCT04349319

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

6.4 years

First QC Date

April 14, 2020

Last Update Submit

April 25, 2022

Conditions

Distal Humerus Fracture

Outcome Measures

Primary Outcomes (2)

  • Reduction shape

    Reduction shape parameter

    1 year

  • Implant placement

    Implant placement parametes

    1 year

Study Arms (1)

Digital preoperative planning

OTHER

To use digital preoperative planning software

Device: Digital preoperative planning

Interventions

Digital preoperative planningDEVICE

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

Digital preoperative planning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Distal humerus fracture patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokyo Medical University Ibaraki Medical Center

Ami, Ibaraki, 305-0395, Japan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37031170DERIVED

MeSH Terms

Conditions

Humeral Fractures, Distal

Condition Hierarchy (Ancestors)

Elbow FracturesElbow InjuriesArm InjuriesWounds and InjuriesHumeral FracturesFractures, Bone

Central Study Contacts

Yuichi Yoshii

CONTACT

81298871161yy12721@yahoo.co.jp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A case control study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Orthopaedic Surgery

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 16, 2020

Study Start

October 1, 2017

Primary Completion

March 1, 2024

Study Completion

March 1, 2025

Last Updated

April 27, 2022

Record last verified: 2022-04

Locations

JP(1)