Study Comparing Intramedullary Nailing, Plate Fixation, and Non-operative Treatment of Clavicle Fractures
Study Comparing Intramedullary Nailing, Plate Fixation, and Non-operative Treatment of Clavicle Fractures
Patients with acute, displaced fractures of the middle third of the clavicle will be randomly
 assigned into either the non-operative treatment group or the operative treatment group. The
 operative treatment group will be randomly assigned to repair with either an intramedullary
 device or a plate and screws.
Patients with acute, displaced fractures of the middle third of the clavicle will be randomly
 assigned into either the non-operative treatment group or the operative treatment group. The
 operative treatment group will be randomly assigned to repair with either an intramedullary
 device or a plate and screws. Pre-operative variables will be accounted for in detail.
 Operative variables including duration of surgery, length of incision, fluoroscopy times,
 blood loss, and quality of reduction will be recorded. Patients will be followed with regular
 post-operative visits in which radiographs and clinical examination will be performed.
 Outcome variables will include post-operative pain, time to union, union/non-union rate,
 return to work, return to activity, radiographic outcome, complication rates, incidence of
 repeat procedures, cosmesis, and functional outcome based on strength, range of motion, and
 scoring systems. There are five hypotheses for this study: 1) Operative treatment of acute
 displaced midshaft clavicle fractures will yield better patient-based functional outcomes
 when compared to nonoperative treatment as measured by physical assessment of strength and
 range of motion, standardized scoring systems and return to normal daily activities. 2)
 Operative treatment of acute displaced midshaft clavicle fractures will yield lower
 radiographically-determined nonunion rates, improved cosmesis and fewer complaints of
 residual pain when compared to nonoperative treatment. 3) Operative treatment of acute
 displaced midshaft clavicle fractures with intramedullary pinning will be more efficacious
 than operative treatment with plate fixation as measured by duration of surgery, length of
 incision, fluoroscopy time, blood loss, and quality of reduction. 4) Operative treatment of
 acute displaced midshaft clavicle fractures with intramedullary pinning will result in fewer
 complications than operative treatment with plate fixation including; nonunion rate,
 infection, incidence of repeat procedures, refracture rate, and hardware malfunction. 5)
 Operative treatment of acute displaced midshaft clavicle fractures with intramedullary
 pinning will yield lower radiographically-determined nonunion rates, improved cosmesis, and
 fewer complaints of residual pain when compared to operative treatment with plate fixation.
Inclusion Criteria: All candidates with a radiographically confirmed, displaced, midshaft
 clavicle fracture, between the ages of 16 and 80.

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 Exclusion Criteria: Patients presenting with ipsilateral shoulder girdle injury, open
 fracture, pathologic fracture, or associated neurologic injury. Patients who are pregnant
 and therefore, unable to undergo radiologic assessment. Patients deemed incompetent to make
 medical decisions regarding their own health care. Patients unwilling or unable to complete
 postoperative evaluation at 2, 6, and 12 weeks and long term follow-up evaluation at 6 and
 12 months. Prisoners who will be difficult to complete follow-up.

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