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

• Conditions: Humerus Fracture
• Interventions: Procedure: MIPO with Extra-articular Distal Humeral Anatomical Plate

• Registration Number: NCT04307342
• Lead Sponsor: Instituto Traumatologico Dr. Teodoro Gebauer Weisser

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

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

Study Timeline

• Study Start: 2018-07-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-11
• Last Update Submitted: 2020-03-11
• Study First Posted: 2020-03-13
• Last Update Posted: 2020-03-13
• Primary Completion: 2021-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Posterior MIPO	MIPO with Extra-articular Distal Humeral Anatomical Plate	Patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate

Primary Outcome Measures

Name	Time	Method
Bone union	6 months	Radiological Bone union (X-ray or CT)

Secondary Outcome Measures

Name	Time	Method
Range of Motion (Degrees of flexion, extension, pronation and supination)	1 month, 6 months, 1 year	Physical Exam
Radial nerve injury	1 month, 6 months, 1 year	Physical exam (electromyography when needed)
Quick Disabilities of the Arm, Shoulder and Hand	1 month, 6 months, 1 year	Score
Pain (Quantity)	1 month, 6 months, 1 year	Visual Analog Scale
Constant Score	1 month, 6 months, 1 year	Score
Mayo Elbow Score	1 month, 6 months, 1 year	Score

Trial Locations

Locations (1)

Instituto Traumatológico; 🇨🇱 Santiago, Región Metropolitana, Chile