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

Humerus Fracture Clinical Trial

— MIPOH  

Official title:

Posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04307342
• Other study ID #: MIPOH
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: July 2022

Study information

• Verified date: March 2020
• Source: Instituto Traumatologico Dr. Teodoro Gebauer Weisser
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Clinical

• Pain

• ROM

Functional

• Constant Score

• MEPS

• QuickDASH

Radiological

• Bone union

Complications

• Infection

• Nerve injury

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Humerus Fracture

Intervention

Procedure:
• MIPO with Extra-articular Distal Humeral Anatomical Plate
MIPO with Extra-articular Distal Humeral Anatomical Plate

Locations

Country	Name	City	State
Chile	Instituto Traumatológico	Santiago	Región Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Traumatologico Dr. Teodoro Gebauer Weisser	University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone union	Radiological Bone union (X-ray or CT)	6 months
Secondary	Pain (Quantity)	Visual Analog Scale	1 month, 6 months, 1 year
Secondary	Range of Motion (Degrees of flexion, extension, pronation and supination)	Physical Exam	1 month, 6 months, 1 year
Secondary	Constant Score	Score	1 month, 6 months, 1 year
Secondary	Mayo Elbow Score	Score	1 month, 6 months, 1 year
Secondary	Quick Disabilities of the Arm, Shoulder and Hand	Score	1 month, 6 months, 1 year
Secondary	Radial nerve injury	Physical exam (electromyography when needed)	1 month, 6 months, 1 year