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

NCT03533634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-05-23

No results posted yet for this study

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.

Conditions

  • Closed Fracture of Shaft of Clavicle

Interventions

PROCEDURE

Open Reduction Internal Fixation superior plate

3.5mm superior reconstruction plate

PROCEDURE

Open Reduction Internal Fixation anteroinferior plate

3.5mm anteroinferior reconstruction plate

Sponsors & Collaborators

  • UMAE Hospital de Traumatologia y Ortopedia de Puebla

    lead OTHER

Principal Investigators

  • Jose A Manrique, MD · UMAE Hospital de Traumatologia y Ortopedia de Puebla

  • Gustavo Rivera Saldivar, MD · UMAE Hospital de Traumatologia y Ortopedia de Puebla

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-01
Primary Completion
2017-09-30
Completion
2018-01-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03533634 on ClinicalTrials.gov