Posterior Minimally Invasive Plate Osteosynthesis (MIPO)... | NCT04307342

Studies
Posterior Minimally Invasive Plate Osteosynthesis (MIPO) for Humerus Diaphyseal Fractures

NCT04307342

Sponsor

Instituto Traumatologico Dr. Teodoro Gebauer Weisser

Status

Unknown status

Last Update Posted

Mar 13, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Humerus Fracture

Interventions

MIPO with Extra-articular Distal Humeral Anatomical Plate

Countries

Chile

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

Mar 2020

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

Jul 1, 2018Actual

Primary Completion Date

Jul 2021Estimated

Completion Date

Jul 2022Estimated

First Submitted Date

Mar 11, 2020

First Submission Date that Met QC Criteria

Mar 11, 2020

First Posted Date

Mar 13, 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

Mar 11, 2020

Last Update Posted Date

Mar 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Julio Contreras, Shoulder and Elbow Surgeon, Instituto Traumatologico Dr. Teodoro Gebauer WeisserPrincipal Investigator

Lead Sponsor

Instituto Traumatologico Dr. Teodoro Gebauer WeisserOTHER

Collaborators

Name	Class
University of Chile	OTHER

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

The primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate.

Detailed Description

Clinical

Pain
ROM

Functional

Constant Score
MEPS
QuickDASH

Radiological

- Bone union

Complications

Infection
Nerve injury

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Posterior MIPO		Patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate	Procedure: MIPO with Extra-articular Distal Humeral Anatomical Plate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MIPO with Extra-articular Distal Humeral Anatomical Plate	Procedure	MIPO with Extra-articular Distal Humeral Anatomical Plate	Posterior MIPO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone union	Radiological Bone union (X-ray or CT)	6 months

Secondary Outcomes

Measure	Description	Time Frame
Pain (Quantity)	Visual Analog Scale	1 month, 6 months, 1 year
Range of Motion (Degrees of flexion, extension, pronation and supination)	Physical Exam

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Closed diaphyseal humerus fracture at the junction of the middle third with distal

Exclusion Criteria:

Open fractures, proximal humerus extension, distal articular compromise, polytrauma, more than 2 weeks of trauma

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

Patients consulting in the emergency department of the Instituto Traumatológico for a fracture of the humerus

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Traumatológico	Recruiting	Santiago	Santiago Metropolitan	7510664	Chile

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006810	Humeral Fractures
D050723	Fractures, Bone

Ancestor Terms

ID	Term
D001134	Arm Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided