Thurs., 10/16/08 Tibia/Polytrauma, Paper #6, 3:37 pm OTA-2008
A Prospective Multicenter Study of Intramedullary Nailing versus Casting of Stable Tibial Fractures
SouthEast Fracture Consortium; William T. Obremskey, MD, MPH (a-Synthes; e-Medtronic, Osteogenix);
Vanderbilt University, Nashville, Tennessee, USA
Purpose: The purpose of this study is to determine if intramedullary nailing or casting is optimal treatment of stable tibial fractures.
Methods: 55 patients were prospectively enrolled in a multicenter surgeon experienced based trial on intramedullary nailing (IMN) or casting of stable tibial fractures that meet Sarmiento’s criteria for stable tibia fractures. These are fractures that have less than 12 mm of shortening, 10° of angulation, and are an isolated injury. Surgeons chose which method of treatment they preferred for this study and treated all patients entered in this study that fit the criteria with this method of treatment. Patient histories and documentation of comorbidities of smoking, diabetes, medication use, and work type were recorded. Radiographs were taken until union and range of motion of knee and ankle joints were also assessed. Radiographic alignment was defined as malalignment (>5°) and malunion (>10°). Functional outcome measures of Short Musculoskeletal Assessment scores (SMFA) and a knee pain score were scheduled at 6 weeks, and at 3 and 6 months.
Results: No differences were found in the demographics of age, sex, or mechanism of injury, or comorbidities of smoking, diabetes, or medication use that inhibits bony union between the two groups. At 3 months, significant differences between the cast and IMN groups were noted, in return to work (39% vs 76%, P = 0.4); ankle dorsiflexion (7° vs 12°, P = 0.012); plantar flexion (28° vs 39°, P = 0.027); and all SMFA domains of Dysfunction Index, Bother Index, Daily Activities, Emotional Status, and Arm/Hand Function (P <0.05). The SMFA Mobility Function was nearly significant at P = 0.065. At 6 months, malalignment was present in 3 of 25 (12%) in the cast group and in 1 of 29 (3.4%) in the IMN group. Malunion was present in only 1 of 25 (4%) in the cast group. Nonunion was present in 2 of 25 (8%) in the cast group and in 1 of 29 (3.4%) of the IMN group. No statistical difference was seen in alignment or union. At 6 months, no differences were seen in ankle motion, SMFA scores, return to work, or union.
Conclusions and Significance: Patients with stable tibial fractures may be treated with IMN or cast with improved clinical and functional outcomes at 3 months, but no differences in any other outcome measure. Patients treated in a cast may have a higher incidence of malalignment or malunion.
If noted, the author indicates something of value received. The codes are identified as a-research or institutional support; b-miscellaneous funding; c-royalties; d-stock options; e-consultant or employee; n-no conflicts disclosed, and *disclosure not available at time of printing.
• The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an “off label” use). ◆FDA information not available at time of printing. Δ OTA Grant.