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

UMAE Hospital de Traumatologia y Ortopedia de Puebla

Status: Completed

Conditions: Closed Fracture of Shaft of Clavicle

Treatments: Procedure: Open Reduction Internal Fixation anteroinferior plate; Procedure: Open Reduction Internal Fixation superior plate

Study type: Interventional

Funder types: Other

Identifiers

NCT03533634

UMAE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

superior group

Experimental group

Description:

this group with midshaft clavicle fracture were treated with superior reconstruction plate

Treatment:

Procedure: Open Reduction Internal Fixation superior plate

anteroinferior group

Experimental group

Description:

this group with midshaft clavicle fracture were treated with anteroinferior reconstruction plate

Treatment:

Procedure: Open Reduction Internal Fixation anteroinferior plate