Clavicle fractures
Conditions
Interventions
The present study should contain 50 individuals in each of the groups. Considering a 10% loss to follow-up during one year of follow-up, we will include 110 patients in the study. Randomization: After
Sponsors
Fundação Faculdade de Medicina de São José do Rio Preto
Fundação Faculdade de Medicina de São José do Rio Preto
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Volunteers with acute midshaft clavicle fractures (up to 10 days after the trauma); adults between 18 and 65 years old; no medical contraindications for the proposed treatments; acceptance and understanding of the informed consent form
Exclusion criteria
Exclusion criteria: Patients with proximal or distal clavicle fractures, fracture with deviation or shortening greater than 2 cm between the bone fragments in at least one of the radiographic views (AP or Zanca); pathological fracture; open fracture; associated neurovascular injury diagnosed on physical examination; head trauma (Glasgow <12); fracture and/or dislocations in the ipsilateral upper limb; previous diseases in the affected limb that may influence the results; inability to maintain outpatient clinical follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find similar results between the proposed treatment methods when evaluating the function of the upper limb affected by the fracture analyzed through the DASH questionnaire (Disabilities of the Arm, Shoulder and Hand). | — |
Secondary
| Measure | Time frame |
|---|---|
| For the evaluation of fracture consolidation, radiographs will be used and treatment failure will be considered when there is non-union with the need to change treatment to surgery.;Adverse effects such as clavicle deformities and asymptomatic non-union will also be analyzed.;Function of the limb affected by the fracture, this outcome will be analyzed through the application of a questionnaire such as the UCLA (Modified University of California at Los Angeles);Quality of life evaluated through of the SF-12 questionnaire (Short Form). ;Time required for participants to return to their usual activities after treatment.;The pain assessed using the visual analogue pain scale. | — |
Countries
Brazil
Contacts
Public ContactOreste Lemos Carrazzone
Fundação Faculdade de Medicina de São José do Rio Preto
Outcome results
None listed