Comparison of Nailing, Plate Fixation and Non-operative Treatment of Midshaft Clavicle Fractures

Clavicle Fracture Clinical Trial

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

Status Withdrawn

Clinical Trial Summary

Until recently, clavicle fractures have been treated mainly with a sling or brace and felt to have favorable outcomes. Recently, however, data has been published suggesting that these injuries are not as harmless as once thought and, if treated without surgery, may result in lasting functional deficits. As a result, surgery for clavicle fractures is becoming increasingly more accepted as a better treatment option. There are two basic methods of operative treatment. The first involves placement of a metal rod within the middle of the clavicle through a small incision in the skin. Proponents of this technique believe that it has improved cosmetic outcome because of a smaller incision, less post operative pain, and possibly a faster return to activity when compared to other surgical treatments. The second method involves making a larger incision over the clavicle, exposing a large portion of the bone, and fixing the fracture with a plate and screws. Proponents of this method cite better stablity and a decreased risk of the hardware migrating from its intended position among other advantages. This study would propose to determine if these two methods of fracture fixation are necessary and if so, which would provide better outcomes following their use in selected patients.

Clinical Trial Description

Poor results following non-operative treatment of displaced midshaft clavicle fractures have been described by several authors. McKee et al(2006) presented 30 patients with displaced midshaft clavicle fractures treated nonoperatively. At a mean follow up of 55 months, only 18 had returned to their preinjury levels of work and recreational activity. Mean DASH and Constant shoulder scores were significantly inferior to the normal population. Hill et al (1997) reviewd 52 cases of completely displaced middle third clavicle fractures at a mean follow up of 38 months. They report a nonunion rate of 15% and 31% overall unsatisfactory results. Poor results were related to residual pain, brachial plexus irritation, and cosmetic complaints. In a systematic review including 771 displaced midshaft fractures, Zlodowski (2005) noted a non-union rate of 15% following nonoperative treatment. Nonunion rates following operative treatment were 2% and 2.2% respectively for intramedullary nailing and plate fixation.

Several authors are have presented favorable results following intramedullary nailing of acute clavicle fractures. In a nonrandomized study comparing intramedulllary nailing versus plating versus nonoperative treatment of displaced fractures, Thyagarajan et al (2005)noted no nonunions in the operative group and a 24% nonunion rate in the nonoperative group. Patients treated with an intramedullary device had shorter hospital stays, earlier mobilization and less scar-related pain when compared to those treated with a plate. Four of 17 (24%)patients treated with a plate developed scar related pain and 18% had prominent hardware. Jubel et al (2003) treated 58 markedly displaced fractures in 55 patients with an intramedullary titianium nail. There was a single nonunion and there were no infections, implant displacements or refractures. Patients experienced marked postoperative pain reduction. In a subset of 12 athletes treated under this protocol, these athletes resumed training at a mean 5.9 days and returned to competition at 16.9 days. However, Judd et al (2005) and Grassi et al (1999) report inferior results associated with intramedullary fixation when compared to nonoperative treatment, citing high complications rates with intramedullary nails and acceptable results following nonoperative treatment.

Numerous authors have published data regarding plate fixation of acute clavicle fractures. Smith et al (2001) conducted a randomized clinical trial comparing plating and nonoperative treatment of 100% displaced midshaft clavicle fracures. They report a nonunion rate of 24% (12/50) in the nonoperative group and 0% (0/50) nonunion rate in the operative group. Additionally, 30% of the patients in the nonoperative group reported upper extremity neurologic complaints with overhead activities and 44% reported cosmetic complaints. However, 30% of patients in the operative group requested hardware removal. Poigenfurst et al (1992) treated a total of 131 clavicle fractures in 129 patients. They experienced no bony infections. Four clavicles refractured after removal of the plate and five operations led to pseudarthroses which were successfully treated by reoperation. Despite these complications, they state that the radiological and clinical results in the majority of patients were excellent. Bostman et al (1997)reported on the complications associated with plating of midhaft clavicle fractures, noting 23% complications rate while treating 103 fractures. These complications included deep infection, plate breakage, and refracture following plate removal. Coupe et al (2005) suggest that such a high complication rate may be avoided using an infraclavicular approach to the clavicle. In their series of 89 patients treated in this manner, they report only two major complications and six minor complications. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clavicle Fracture
• Fractures, Bone

• NCT number: NCT01307670
• Study type: Interventional
• Source: University of Missouri-Columbia
• Status: Withdrawn
• Phase: N/A
• Start date: April 2008
• Completion date: April 2008