Rationale and design of the plate or pin (POP) study for dislocated midshaft clavicular fractures: study protocol for a randomised controlled trial.

BACKGROUND

To describe the rationale and design of a future study comparing results of plate fixation and Elastic Stable Intramedullary Nailing (ESIN) with a Titanium Elastic Nail (TEN) for adults with a dislocated midshaft clavicular fracture.

METHODS/DESIGN: Prospective randomized multicenter clinical trial in two level 1 and one level 2 trauma centers. 120 patients between 18 and 65 years of age will be included. They are randomized to either plate fixation or ESIN with a TEN with a one year follow-up. Sixty patients will be treated with plate fixation and 60 patients will be treated with ESIN. Primary outcome parameter is the Disabilities of the Arm, Shoulder and Hand score after 6 months. Secondary outcome parameters are Constant Shoulder Score, complications, experienced pain, radiologic consolidation and cosmetics after both procedures.

DISCUSSION

Prospective randomized studies comparing operative techniques for treatment of dislocated midshaft clavicular fracture are lacking. By studying shoulder function, complications, quality of life, radiographic union, cosmetics as well as experienced pain, a complete efficacy assessment of both procedures will be performed.

TRIAL REGISTRATION

The POP study is registered in the Dutch Trial Register (NTR NTR2438).