Fixation of Midshaft Fractures of the Clavicle With Plate and Intramedullary Flexible Nail

• Fracture Healing Time [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  Time spent until complete bone healing.
• Residual shortening of the clavicle [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  The length of both clavicles is compared.
• Implant Failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  Number of cases of implant failure in each group.

The purpose of this study is to compare the clinical and radiographic results of patients with fractures of the middle clavicle treated by the techniques of fixation with plates and intramedullary flexible nails.

Midshaft fractures of the clavicle are classically treated by non-surgical methods, with literature reports of high rates of good results. However, different researches have shown higher rates of nonunion and functional complaints related to malunion of clavicular fractures. Currently, indications for surgical treatment have become more frequent and are mainly the following: shortening greater than or equal to 2.0 cm, multiple trauma, fractures or imminent exposure and associated neurovascular injury.

The use of plates in the treatment of midshaft fractures of the clavicle is widely described in literature. It is regarded by many as the gold standard, being associated with a high union rate and low complication rate. Among the types of plates used are the reconstruction plates, dynamic compression plates (DCP) or low-contact dynamic compression plates (LC-DCP), semi-tubular plates, pre-molded plates and plates with angular stability. Among the main complications reported are postoperative infection, loosening of material synthesis, numbness at the incision, damage to neurovascular structures, pseudoarthrosis and discomfort at the surgical site by the presence of the plate.

The use of titanium elastic nails for fixation of fractures of the clavicle has received increased attention in recent years and various authors have reported their experience with this type of synthesis. One suggested advantage is the support given by the 3-point flexible nail, which provides good biomechanics resistance, and uses the principle of relative stability, favoring callus formation. Compared with plain steel wire, have a lower risk of migration, since they have greater flexibility and better bone fixation.

The purpose of this study is to compare the clinical and radiographic results of patients with fractures of the middle clavicle treated by the techniques of fixation with plates and intramedullary flexible nails.

• Procedure: Fracture fixation with Plate.
  Reconstruction plates.
• Procedure: Fracture fixation with intramedullar nailing
  ESIN (Elastic Stable Intramedullary Nailing)

• Active Comparator: Plate Fixation
  Reconstruction Plate
  Intervention: Procedure: Fracture fixation with Plate.
• Active Comparator: Intramedullary Nailing
  ESIN (Elastic Stable Intramedullary Nailing)
  Intervention: Procedure: Fracture fixation with intramedullar nailing

Inclusion Criteria:

1. Displaced Fractures of the middle third of the clavicle (no contact between the main fragments)
2. Age between 16 and 65 year old;
3. Terms of consent signed by the patient or guardian.

Exclusion Criteria:

1. Fracture of medial or lateral third of the clavicle;
2. Cortical contact between the main fracture fragments;
3. Age below 16 years old or more than 65 years old;
4. Pathological fracture;
5. Ipsilateral previous injuries of the shoulder or upper limb;
6. Ipsilateral associated fractures of the shoulder or upper limb;
7. Neuro-vascular injury associated;
8. Open fracture not eligible for primary internal fixation;
9. Clinical contraindication for surgery;
10. Fracture older than 30 days;
11. Patient not cooperative or ineligible for the follow-up;
12. Lack of consent to participate.