![]() ![]() Standard pin insertion and external fixator placement technique was utilized. This was done to maintain an appropriate balance of type of pin "closest to" and "farthest away" from the fracture site and to balance out the types of pins in metaphyseal and diaphyseal bone. For example, if SS was placed "closest to" the fracture site and SC was placed "farthest away" from the fracture site in the proximal clamp (as determined by the randomization table), then the SS pin was placed "farthest away" from the fracture site and the SC pin was placed "closest to" the fracture site in the distal clamp. If a patient had two clamps eligible for study participation, the randomization table was utilized for the proximal clamp, and the pins in the distal clamp were placed opposite to those in the proximal clamp. If a patient had one clamp eligible for participation in the study, the two study pins (SC & SS) were randomized between "closest to" and "farthest away" using a random number table. Randomization for each clamp was by position in the clamp as "closest to" or "farthest away" from the fracture site. Pins were randomized within each fixator clamp to allow a side-by-side comparison of each experimental (SC) and control (SS) pin. In each clamp, one silver-coated and one stainless steel pin was placed. The proximal and distal clamps of the fixator were each eligible for inclusion in the study. Since silver does not leach either locally or systemically from a coated pin, we used each external fixator clamp as an individual experiment to minimize patient and mechanical variability. There were six fractures of the tibial shaft, twelve distal tibia fractures, and two tibial plateau fractures ( Table 1). Open fractures occurred in seven patients. The average age of the patients was 43 years (range 18-65 years). Nine fractures occurred in the right tibia, nine in the left tibia, and one patient had bilateral tibia fractures. Three patients had prior fractures of the tibia, two patients had crush injuries, and one patient each had psoriasis, a transient popliteal artery occlusion, and foot compartment syndrome. Eight patients were smokers and eleven were non-smokers. The remaining nineteen patients included fifteen men and four women. Three initially enrolled patients were excluded from analysis because their external fixator was removed and their fracture was internally fixed within two weeks of injury. Also excluded were wire fixators and metaphyseal T-clamps. We excluded patients treated with temporary frames, as well as patients with obvious sources of infection, pathologic fractures, and immunosuppression. Between June, 1998 and June, 1999 we enrolled 22 patients treated with a monolateral clamp design external fixator for fractures of the tibia into this prospective, randomized study. The study was approved by the institutional review board at the University of Iowa. We designed and performed this prospective, randomized study to test the hypothesis that silver-coated pins decrease the pin infection rate and improve the pin-bone interface characteristics when compared to traditional stainless steel pins. ![]() 19 Although silver coated pins are now commercially available, no clinical study has been performed to confirm their efficacy. 17, 18 Silver coating has been advocated for use on external fixation pins to decrease infection rate, and a small, animal study has demonstrated decreased infection and motion at the pin-bone interface. 16 Silver-based creams for wound care and silver coatings for catheters have decreased infection rates with minimal systemic effects. Silver, with its potent, broad-spectrum antibacterial activity, has had many clinical uses. A method to decrease the rate of pin infection, therefore, has tremendous clinical appeal. Complications related to pin tract infection include need for pin change or removal, failure of fracture healing, septic arthritis, and osteomyelitis. 1 – 15 This high infection rate has been attributed to the conduit that the pins provide between the skin and underlying soft tissue and bone. Pin tract infection is the most significant complication associated with the use of external fixation and has been reported to occur in up to 63% of pins. ![]()
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