Upper end humerus fracture
Conditions
Interventions
A collaborator, who didn’t participate in the study, generated a randomization list on the website "http:www.randomization.com", in random blocks and stratified onto levels corresponding to the Neer’s
Sponsors
Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE
Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE
Eligibility
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Male and female patients; with proximal humeral fractures in 3 or 4 parts; involvement of the surgical neck; tuberosities deviation greater than 0.5 cm; contact between the diaphysis and the humeral head fragment smaller then fifty percent; patient aged over or equal to sixty years old; maximum time of fracture of 14 days
Exclusion criteria
Exclusion criteria: Patient's non-agreement to sign the free and informed consent form; 1- or 2-part fractures; dislocation fractures; pathological fractures; open fractures; associated fractures; head split joint fractures; patient's inability to understand the questionnaires; active or previous shoulder infections; nerve injury in the limb; infeasibility of perform osteosynthesis; irreparable rotator cuff injuries; previous shoulder surgeries; smoking; patients who do not agree with the surgical indication; any affection of the proximal end of the contralateral humerus that changes it's anatomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find superior clinical outcomes in the study group, evaluated by the Coinstant-Murley score translated and culturally adapted to the Portuguese language, which assigns scores for pain (0 to 15 points), activities of daily living (0 to 20 points), range of motion (0 to 40 points) and strength (0 to 25 points) and whose total score can vary from 0 (worst result) to 100 points (best result), with 3, 6, 9 and 12 months post-operative. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find superior clinical outcomes in the study group, evaluated by quantitative evaluation of frontal flexion strength, with B050 model brand Black-Decker? portable digital dynamometer , with graduation of 10 grams, maximum capacity of 50 kilograms and the patient sitting, with the limb starting from the position of 90? of frontal flexion, extension of the elbow and the forearm pronated, at 3, 6, 9 and 12 months postoperatively.;It is expected to find, in the study group, more anatomical reductions of the fractures, measured on radiographs with a true frontal view of the shoulder in neutral rotation, bay comparing the head-diaphysis angle (formed between the perpendicular line to the anatomical neck and the parallel line to the long axis of the humeral diaphysis) between the operated side and the contralateral side and by measuring the humeral height on the operated shoulder (distance between the apex of the humeral head and the apex of the plate) at 1 day, 6 weeks, 3, 6, 9 and 12 months postoperatively. ;It is expected to find, in the study group, lower rates of complications (defective consolidation, non-consolidation, loss of reduction, insufficient reduction, osteonecrosis, joint penetration of screws, segmental collapse, refracture, nerve damage, infection, stiffness, synthesis material loosening)) measured on radiographs, true frontal view of the shoulder with neutral rotation at 1 day, 6 weeks, 3, 6, 9 and 12 months postoperatively.;It is expected to find superior clinical outcomes in the study group, evaluated by the University of California at Los Angeles scale translated and culturally adapted to the Portuguese language, witch assigns scores for pain (0 to 10 points) function (0 to 10 points)range of active frontal flexion (0 to 5 points), active frontal flexion strength (0 to 5 points) and patient satisfaction (0 to 5 points) and whose total score can vary from (worst result) do 35 points (best result), with 3, 6, 9 and 12 months post-o | — |
Countries
Brazil
Contacts
Public ContactAntonio Junior
Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE
Outcome results
None listed