Reuse of external fixation components: a randomized trial.
OBJECTIVE
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.


METHODS
Randomized clinical trial


METHODS
Single center, Level I trauma center


METHODS
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.


METHODS
Consented patients were entered into a trial of new versus refurbished nonimplantable external fixation components for their injury (all pins were new).


METHODS
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.
Sung
Jinsil K
JK
Boston Medical Center, Boston, MA 02118, USA.
Levin
Rafael
R
Siegel
Jodi
J
Einhorn
Thomas A
TA
Creevy
William R
WR
Tornetta
Paul
P
D000328:Adult; D000368:Aged; D017046:Cost Savings; D017743:Equipment Reuse / Q000191:economics; D016267:External Fixators / Q000191:economics; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011885:Radius Fractures / Q000601:surgery*; D013978:Tibial Fractures / Q000601:surgery*