Reuse of external fixation components: a randomized trial

OBJECTIVES: External fixation devices are sold in the United States as single-use devices and can be costly. Approved processes for refurbishment of nonimplantable components are available. We evaluated one such program for safety, efficacy, and fiscal ramifications. DESIGN: Randomized clinical trial SETTING: Single center, Level I trauma center PATIENTS/PARTICIPANTS: During the 30-month enrollment period (November 16, 2001 to May 16, 2004), 41 patients (13%) of 315 patients were not able to consent and were excluded. A total of 178 (65%) of the 274 eligible patients who were offered entry into a randomized trial of new versus refurbished external fixation components for their injury refused to participate, leaving 96 (35%) of the 274 eligible patients entered into the study. INTERVENTION: Consented patients were entered into a trial of new versus refurbished nonimplantable external fixation components for their injury (all pins were new). MAIN OUTCOME MEASUREMENTS: The frames were evaluated at the time of removal for efficacy and the complications of pin tract infections, loss of fixation, or loosening of components. RESULTS: A total of 48 distal radius fractures, 29 pilon fractures, and 19 tibial plateau fractures were entered into the study. With the 96 fractures treated in our study (50 new frames, 46 reused frames), we found no statistical differences in the incidence of pin tract infections (46% versus 52%, P=0.32), loss of fixation (4% versus 4%, P=0.70), or loosening of the components (1% versus 1%, P=1.0). CONCLUSIONS: Sixty-five percent of consentable patients did not wish to have an external fixation frame with refurbished clamps. Our study demonstrated that this type of program is safe and effective with an actual cost savings of $65,452. The potential savings of such a program is 25% of the cost of all new frames

Impact of centre volume, surgeon volume, surgeon experience and geographic location on reoperation after intramedullary nailing of tibial shaft fractures

Background: Tibial shaft fractures are the most common long-bone injury, with a reported annual incidence of more than 75 000 in the United States. This study aimed to determine whether patients with tibial fractures managed with intramedullary nails experience a lower rate of reoperation if treated at higher-volume hospitals, or by higher-volume or more experienced surgeons. Methods: The Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) was a multicentre randomized clinical trial comparing reamed and nonreamed intramedullary nailing on rates of reoperation to promote fracture union, treat infection or preserve the limb in patients with open and closed fractures of the tibial shaft. Using data from SPRINT, we quantified centre and surgeon volumes into quintiles. We performed analyses adjusted for type of fracture (open v. closed), type of injury (isolated v. multitrauma), gender and age for the primary outcome of reoperation using multivariable logistic regression. Results: There were no significant differences in the odds of reoperation between high- and low-volume centres (p = 0.9). Overall, surgeon volume significantly affected the odds of reoperation (p = 0.03). The odds of reoperation among patients treated by moderate-volume surgeons were 50% less than those among patients treated by very-low-volume surgeons (odds ratio [OR] 0.50, 95% confidence interval [CI] 0.28-0.88), and the odds of reoperation among patients treated by high-volume surgeons were 47% less than those among patients treated by very-low-volume surgeons (OR 0.53, 95% CI 0.30-0.93). Conclusion: There appears to be no significant additional patient benefit in treatment by a higher-volume centre for intramedullary fixation of tibial shaft fractures. Additional research on the effects of surgical and clinical site volume in tibial shaft fracture management is needed to confirm this finding. The odds of reoperation were higher in patients treated by very-low-volume surgeons; this finding may be used to optimize the results of tibial shaft fracture management