Study Comparing Intramedullary Nailing, Plate Fixation, and Non-operative Treatment of Clavicle Fractures

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Comparison of Intramedullary Nailing, Plate Fixation, and Non-operative Treatment of Acute, Displaced, Midshaft Clavicle Fractures: a Prospective Randomized Trial

Conditions
-----------------
Clavicle Fractures

Intervention / Treatment
-----------------
* Other: Non-operative Treatment
* Procedure: Operative Treatment-Plate Fixation
* Procedure: Operative Treatment-Intramedullary Pinning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All candidates with a radiographically confirmed, displaced, midshaft clavicle fracture, between the ages of 16 and 80. - 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. -

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No surgery<br>Non-operative Treatment | Other: Non-operative Treatment<br>* A figure-of-8 brace will be applied to afflicted extremity in clinic. The patient will be instructed on proper application of the brace and asked to continue wearing the brace for 2 to 6 weeks, depending on the patient's level of comfort.<br>|
| Active Comparator: Plate fixation<br>Operative Treatment-Plate fixation | Procedure: Operative Treatment-Plate Fixation<br>* Plate fixation of the clavicle fracture will be performed utilizing a 3.5-mm dynamic compression plate.<br>|
| Active Comparator: Intramedullary pinning<br>Operative Treatment-Intramedullary Pinning | Procedure: Operative Treatment-Intramedullary Pinning<br>* Clavicle fracture will be repaired through intramedullary pinning using The Rockwood Clavicle Pin (DePuy Orthopaedics, Warsaw, IN).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability of the Arm, Shoulder, and Hand (DASH) |  | 2, 6, and 12 weeks and 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Constant Pain Score |  | 2, 6, and 12 weeks and 6 and 12 months |