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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plate fixation | Active Comparator | Reconstruction plate |
|
| ESIN | Active Comparator | ESIN (Elastic Stable Intramedullary Nailing) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plate fixation | Procedure | Reconstruction plate |
| |
| ESIN |
| Measure | Description | Time Frame |
|---|---|---|
| DASH score | Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| DASH score | Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function) | 12 months |
| Constant-Murley Score | Shoulder functional score (0: worst function; 100: best function) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando B Andrade-Silva, MD | University of Sao Paulo - Department of Orthopedics and Traumatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo - Department of Orthopedics and Traumatology | São Paulo | São Paulo | 05403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25878305 | Derived | Andrade-Silva FB, Kojima KE, Joeris A, Santos Silva J, Mattar R Jr. Single, superiorly placed reconstruction plate compared with flexible intramedullary nailing for midshaft clavicular fractures: a prospective, randomized controlled trial. J Bone Joint Surg Am. 2015 Apr 15;97(8):620-6. doi: 10.2106/JBJS.N.00497. |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Procedure |
ESIN (Elastic Stable Intramedullary Nailing) |
|
| 6 and 12 months PO |
| Time to Union | Time necessary to reach complete union measured in weeks | Monthly |
| Radiographic residual shortening | Clavicles shortening compared to the contralateral side | 6 months |
| Patient satisfaction with the treatment | Subjective measurement. Patients are questioned about their satisfaction with the treatment instituted. Binary outcome. | 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 | Monthly |