The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with plates or intramedullary flexible nails fixation.
Midshaft clavicular fractures are classically treated with non-surgical methods, supported by many authors as an effective treatment. However, different researches have shown high rates of nonunion and clavicle malunion related to the nonoperative treatment. Currently, indications for surgical treatment are wider and include mainly the following: shortening greater than or equal to 2.0 cm, multiple trauma, open fractures or with imminent exposure and associated neurovascular injury. Plate fixation of midshaft clavicular fractures is widely described in the literature, and is considered the gold standard by different authors, associated with a high union rate and a low complication rate. Different types of plates have been used, including reconstruction plates, dynamic compression plates (DCP), low-contact dynamic compression plates (LC-DCP), semi-tubular plates, and pre-molded locking plates. Possible complications are postoperative infection, hardware loosening or failure, peri-incision paresthesia, neurovascular iatrogenic lesions, nonunion, and hardware related symptoms. Elastic stable intramedullary nailing (ESIN) technique has been used in recent years in the treatment of midshaft clavicular fractures. Different studies report excellent functional results and low complication rates. Some theoretical advantages in relation to plates are the 3-point flexible nail support, which provides superior biomechanics resistance and uses the relative stability principle, favoring callus formation. When compared to plain steel wires, titanium nails have lower migration risk, due to its greater flexibility and better bone fixation. The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with reconstruction plates or ESIN.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Reconstruction plate
ESIN (Elastic Stable Intramedullary Nailing)
University of Sao Paulo - Department of Orthopedics and Traumatology
São Paulo, São Paulo, Brazil
DASH score
Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)
Time frame: 6 months
DASH score
Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)
Time frame: 12 months
Constant-Murley Score
Shoulder functional score (0: worst function; 100: best function)
Time frame: 6 and 12 months PO
Time to Union
Time necessary to reach complete union measured in weeks
Time frame: Monthly
Radiographic residual shortening
Clavicles shortening compared to the contralateral side
Time frame: 6 months
Patient satisfaction with the treatment
Subjective measurement. Patients are questioned about their satisfaction with the treatment instituted. Binary outcome.
Time frame: 6 and 12 months
Complication rate
Complications were divided in Minor and Major, as follows: Minor: paresthesia, transient neurologic deficit, implant deformation, partial implant migration, acromioclavicular or sternoclavicular pain, hardware related pain Major: permanent neurologic deficit, total implant failure, total implant migration, refracture, reoperation, nonunion
Time frame: Monthly
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