Functional Outcome in Midshaft Clavicle Fracture, Treated With Superior Versus Anteroinferior Reconstruction Plate

Not Applicable

Completed

• Conditions: Closed Fracture of Shaft of Clavicle
• Interventions: Procedure: Open Reduction Internal Fixation superior plate; Procedure: Open Reduction Internal Fixation anteroinferior plate

• Registration Number: NCT03533634
• Lead Sponsor: UMAE Hospital de Traumatologia y Ortopedia de Puebla

Brief Summary

The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques. the first one was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle. the patients had the same rehabilitation program and evaluated with functional scores at 30, 60, 90 and 365 days after surgery. biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.

Detailed Description

The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques.

the first technique was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle.

the patients had the same rehabilitation program and evaluated with Disabilities Arm Shoulder and Hand functional outcome score and Visual Analogue Score for pain at 30, 60, 90 and 365 days after surgery.

biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.

Study Timeline

• Study Start: 2015-03-01
• Primary Completion: 2017-09-30
• Study Completion: 2018-01-15
• Study First Submitted: 2018-04-30
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-10
• Last Update Submitted: 2018-05-10
• Study First Posted: 2018-05-23
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• traumatic fracture
• ao 15 b1 and 15 b2
• no previous shoulder lesions
• no further 7 days fractures
• closed fracture

Exclusion Criteria

• calcium diseases
• Previous shoulder pain
• other fractures associated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
superior group	Open Reduction Internal Fixation superior plate	this group with midshaft clavicle fracture were treated with superior reconstruction plate
anteroinferior group	Open Reduction Internal Fixation anteroinferior plate	this group with midshaft clavicle fracture were treated with anteroinferior reconstruction plate

Primary Outcome Measures

Name	Time	Method
Disabilities of Arm Shoulder and Hand score (DASH)	365 days after surgery	we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale score (VAS)	365 days after surgery	we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain