Allograft bone is widely used in orthopaedic surgery, but peri-operative infection of the graft remains a common and disastrous complication. The efficacy of systemic prophylactic antibiotics is unproven, and since the graft is avascular it is likely that levels of antibiotic in the graft are low.

Using an electrical potential to accelerate diffusion of antibiotics into allograft bone, high levels were achieved in specimens of both sheep and human allograft. In human bone these ranged from 187.1 mg/kg in endosteal (sd 15.7) to 124.6 (sd 46.2) in periosteal bone for gentamicin and 31.9 (sd 8.9) in endosteal and 2.9 (sd 1.1) in periosteal bone for flucloxacillin. The antibiotics remained active against bacteria in vitro after iontophoresis and continued to elute from the allograft for up to two weeks.

Structural allograft can be supplemented directly with antibiotics using iontophoresis. The technique is simple and inexpensive and offers a potential means of reducing the rate of peri-operative infection in allograft surgery. Iontophoresis into allograft bone may also be applicable to other therapeutic compounds.

Introduction and Aims: Iontophoresis is a method to introduce antibiotic molecules into allograft bone using an electrical potential. In-vitro testing has shown that these antibiotics should be released in their bioactive form at therapeutic levels for extended periods of time. This is the first report of iontophoresed allograft implantation into patients.

Method: A method of loading tubular sections of cortical bone was used in theatre prior to implantation. The bone was held vertically in an antibiotic bath with a cylindrical outer electrode and a wire electrode down the centre of the bone. An electrical potential of approximately 90V was applied to drive the antibiotics into the bone. Post-operative serum, drain and allograft antibiotic assays were performed. All patients were followed-up clinically and radiologically. Patients who required a bulk segmental allograft from June 1997 to present were entered into the trial and received iontophoresed bone.

Results: Since June 1997, 35 patients have received 37 iontophoresed allografts. Indications for allograft insertion were limb salvage for tumor (16), poor bone stock associated with infection (12), periprosthetic fracture (seven), aseptic loosening (one) and recurrent dislocation of total hip replacement (one). One patient had acute complications requiring amputation. No patients were lost to follow-up with a mean follow-up of 3.3 years. Two patients required an allograft exchange for fracture and infection. There were two late allograft infections at 10 and 18 months. One patient was revised to another iontophoresed allograft and has had no recurrence at two years. The other infection required above knee amputation. One allograft was revised with allograft exchange and vascularised fibular graft following fracture of metal fixation. There was one case of persistent non-union in a knee fusion, which was treated after 21 months by removal of the intermedullary fixation and allograft and use of an Ilizarov frame. All other allografts are in-situ with no complications related to the allograft. Twelve patients had pre-existing proven infections. None of these patients have been re-infected to date. Therapeutic gentamicin and flucloxacillin levels were detected in drain fluid samples post-operatively, averaging from 39.9 mg/L at two hours to 5.97mg/L at 48 hours for gentamicin and 16.83mg/L at two hours and 2.23 mg/L at 48 hours for flucloxacillin. This was significantly greater than the minimum inhibitory concentration (MIC) against Staphylococcus aureus for gentamicin (0.25mg/L) and flucloxacillin (0.30mg/L). At the same time, blood levels remained in a safe range.

Conclusion: Iontophoresis is a safe and inexpensive method that can be executed in the operating theatre. Iontophoresed bone delivers a high local dose of antibiotic, which may prevent early biofilm formation initiated during allograft handling and exposure to theatre air. With no early infections and no re-infections, further assessment of this technique continues with guarded optimism.