Development of Three Dimensional Preoperative Planning Sy... | NCT04349319

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

NCT04349319

Sponsor

Tokyo Medical University

Status

Unknown status

Last Update Posted

Apr 27, 2022Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Distal Humerus Fracture

Interventions

Digital preoperative planning

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Mar 2024Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Apr 14, 2020

First Submission Date that Met QC Criteria

Apr 14, 2020

First Posted Date

Apr 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2022

Last Update Posted Date

Apr 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yuichi Yoshii, Associate Professor, Department of Orthopaedic Surgery, Tokyo Medical UniversityPrincipal Investigator

Lead Sponsor

Tokyo Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Digital preoperative planning	Other	To use digital preoperative planning software	Device: Digital preoperative planning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Digital preoperative planning	Device	Before the osteosynthesis of distal humerus fracture, we perform digital preoperative planning.	Digital preoperative planning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction shape	Reduction shape parameter	1 year
Implant placement	Implant placement parametes	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Distal humerus fracture patients

Exclusion Criteria:

Patients with a previous history of traumatic injuries to the elbow

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuichi Yoshii	Contact	81298871161		yy12721@yahoo.co.jp

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tokyo Medical University Ibaraki Medical Center	Recruiting	Ami	Ibaraki	305-0395	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37031170	Derived	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.

ID	Term
D000092482	Elbow Fractures
D000092464	Elbow Injuries
D001134	Arm Injuries
D014947	Wounds and Injuries