Abstract
Context: Since the year 2000, allogeneic tissues utilized for operations in humans in the United States have commonly undergone terminal sterilization with gamma irradiation. Ethylene oxide sterilization of tissues processed for human implantation has been abandoned Objectives: (1) To record the long-term successful experience of a precursor transplantation laboratory in the provision of human bone and fascia sterilized with “cold cycle” ethylene oxide; (2) to report the successful experience of a single neurosurgeon operating in a community hospital using only this bone to fuse and stabilize the lumber spine without instrumentation; (3) to review historic and contemporary scientific evidence for the biologic and biomechanical effects of ethylene oxide gas and gamma irradiation exposure on tissues, along with their virucidal, fungicidal and bactericidal properties for surface and interstitial sterilization. Design: Records from the Western Transplantation Services (WTS) laboratory were scrutinized documenting the 18 years of its existence (1978-1996) as well as the voluminous, carefully preserved records of patient interactions, preoperative, operative, and postoperative records archived over three decades from 321 patients undergoing 339 operations by a single neurosurgeon utilizing 1,135 tricortical iliac crest wedges sterilized with ethylene oxide. Main Outcome Measures: Rates of infection and neoplasia in allograft recipients or in laboratory personnel from preparation and distribution of over 50,000 ethylene oxide sterilized allografts provided by a single processing laboratory; lumbar spine fusion rate and complications attributable to grafts among patients receiving these implants. Results: Over 50,000 allografts distributed from Western Tranplantation Services resulted in no reported infections or neoplasia in any recipient and no neoplasia among technicians processing four tissues with exposure to ethylene oxide. Fusion rate among patients undergoing uninstrumented posterior lumbar interbody fusion (PLIF) with tissues distributed by this laboratory was 96% with no reported infections and no allograft fractures. Complication rate of 4% related to the operation and not the performance of the allografts processed by the laboratory. Conclusions: Ethylene oxide sterilization of allogeneic tissues for human transplantation is a safe, efficacious method and merits reconsideration as a remarkably unique surface and interstitial tissue sterilant that is bactericidal, fungicidal and virucidal without compromise of biomechanical integrity of grafts at doses achieving these sterilizing effects.
Highlights
Neurological and orthopedic surgeons often utilize bone grafts to restore the structural integrity and stability of the spine
Over 50,000 allografts distributed from Western Tranplantation Services resulted in no reported infections or neoplasia in any recipient and no neoplasia among technicians processing four tissues with exposure to ethylene oxide
Fusion rate among patients undergoing uninstrumented posterior lumbar interbody fusion (PLIF) with tissues distributed by this laboratory was 96% with no reported infections and no allograft fractures
Summary
Neurological and orthopedic surgeons often utilize bone grafts to restore the structural integrity and stability of the spine. Whereas fresh autogeneic bone is regarded as the "gold standard" for conveying immunologically identical living cells, bone collagen, inductive proteins, and mineral to the host bed, harvesting a large enough quantity of autografts usually requires another incision to obtain iliac crest or other sources of bone. This secondary donorsite wound can be associated with at least ten complications complicating the recovery, to include problems in wound healing, hemorrhage/blood loss/anemia, massive hematoma, deep wound infection, iliac hernia, pelvic instability, fatigue fracture, heterotopic bone formation, lateral femoral cutaneous nerve injury (meralgia paresthetica), and chronic severe donor site pain. Allograft blocks were removed from two young living donors to correct their deforming anterior tibial curves and successfully used to replace a large section of humerus destroyed by suppuration in a four-year-old recipient [2]
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