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.
Randomized clinical trial
Single center, Level I trauma center
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.
Consented patients were entered into a trial of new versus refurbished nonimplantable external fixation components for their injury (all pins were new).
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.
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).
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.
From the *Boston Medical Center; and †Boston University Orthopaedic Surgical Associates, Boston, MA.
Accepted for publication November 21, 2007.
The authors did not receive grants or outside funding in support of their research or preparation of this manuscript.
The devices that are subject of this manuscript are FDA approved.
Reprints: Dr. Paul Tornetta III, MD, Boston Medical Center, 850 Harrison Avenue, Dowling 2 North, Boston, MA 02118 (e-mail: email@example.com).