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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Functional Outcome in Midshaft Clavicle Fracture Patients, Treated With Superior Versus Anteroinferior Reconstruction Plate. Randomized Clinical Trial.

Conditions
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Closed Fracture of Shaft of Clavicle

Intervention / Treatment
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* Procedure: Open Reduction Internal Fixation superior plate
* Procedure: Open Reduction Internal Fixation anteroinferior plate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: superior group<br>this group with midshaft clavicle fracture were treated with superior reconstruction plate | Procedure: Open Reduction Internal Fixation superior plate<br>* 3.5mm superior reconstruction plate<br>|
| Experimental: anteroinferior group<br>this group with midshaft clavicle fracture were treated with anteroinferior reconstruction plate | Procedure: Open Reduction Internal Fixation anteroinferior plate<br>* 3.5mm anteroinferior reconstruction plate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of Arm Shoulder and Hand score (DASH) | 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 | 30 days after surgery | 
| Disabilities of Arm Shoulder and Hand score (DASH) | 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 | 60 days after surgery | 
| Disabilities of Arm Shoulder and Hand score (DASH) | 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 | 90 days after surgery | 
| Disabilities of Arm Shoulder and Hand score (DASH) | 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 | 365 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale score (VAS) | we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain | 30 days after surgery | 
| Visual Analogue Scale score (VAS) | we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain | 60 days after surgery | 
| Visual Analogue Scale score (VAS) | we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain | 90 days after surgery | 
| Visual Analogue Scale score (VAS) | we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain | 365 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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midshaft clavicle fracture, functional outcome, anteroinferior plate, superior plate, reconstruction plate