Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures: a Prospective, Randomized Clinical Trial|
- DASH score [ Time Frame: 6 months ] [ Designated as safety issue: No ]Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)
- DASH score [ Time Frame: 12 months ] [ Designated as safety issue: No ]Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)
- Constant-Murley Score [ Time Frame: 6 and 12 months PO ] [ Designated as safety issue: No ]Shoulder functional score (0: worst function; 100: best function)
- Time to Union [ Time Frame: Monthly ] [ Designated as safety issue: No ]Time necessary to reach complete union measured in weeks
- Radiographic residual shortening [ Time Frame: 6 months ] [ Designated as safety issue: No ]Clavicles shortening compared to the contralateral side
- Patient satisfaction with the treatment [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Subjective measurement. Patients are questioned about their satisfaction with the treatment instituted. Binary outcome.
- Complication rate [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
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
|Study Start Date:||July 2010|
|Study Completion Date:||April 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Plate fixation
Procedure: Plate fixation
Active Comparator: ESIN
ESIN (Elastic Stable Intramedullary Nailing)
ESIN (Elastic Stable Intramedullary Nailing)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410032
|University of Sao Paulo - Department of Orthopedics and Traumatology|
|Sao Paulo, Brazil, 05403-010|
|Principal Investigator:||Fernando B Andrade-Silva, MD||University of Sao Paulo - Department of Orthopedics and Traumatology|