title: Comparison of the clinical efficacy and tolerance of gentamicin PMMA beads on surgical wire versus combined and systemic therapy for osteomyelitis.
abstract: These data do not prove a statistical superiority of conventional antibiotics or Septopal in the treatment of chronic osteomyelitis. This result, however, is complicated by the biased data set represented by the combined treatment. The data do suggest that cost of treatment is considerably less in patients who are treated with local antibiotics (i.e., Septopal) alone. The rate of adverse experiences was directly related to the use of parenteral antibiotics, with higher rates of adverse experiences in the conventional and combined treatment groups. Furthermore, the Cierny-Mader Physiologic Class had the best correlation with outcome, suggesting that host factors are probably of critical importance in inducing remission of chronic osteomyelitis. This protocol was not designed to test the role of debridement in the treatment of osteomyelitis: it was assumed that debridement would be the same in both groups. It is the investigators' strong opinion, however, that adequacy of debridement was an important determinant in quiescence or recurrence in the study patients. Similarly, there was no strict control for adequacy of soft-tissue coverage provided by local or distant tissue transfer. Again, the investigators believe that adequacy, including viability and durability, of soft-tissue covering was an important determinant for the end result in these patients. Other covariants such as smoking, history, nutritional status, and other measures of general health will be added to this model when data are available. This analysis will allow definition of the appropriate clinical situations in which use of Septopal alone or combined with parenteral antibiotic is indicated.
authors.affiliation: Department of Orthopedics, West Virginia University, Morgantown 26506-9196.
authors.forename: J D
authors.initials: JD
authors.lastname: Blaha
authors.forename: J H
authors.initials: JH
authors.lastname: Calhoun
authors.forename: C L
authors.initials: CL
authors.lastname: Nelson
authors.forename: S L
authors.initials: SL
authors.lastname: Henry
authors.forename: D
authors.initials: D
authors.lastname: Seligson
authors.forename: J L
authors.initials: JL
authors.lastname: Esterhai
authors.forename: R B
authors.initials: RB
authors.lastname: Heppenstall
authors.forename: J
authors.initials: J
authors.lastname: Mader
authors.forename: R P
authors.initials: RP
authors.lastname: Evans
authors.forename: J
authors.initials: J
authors.lastname: Wilkins
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002908:Chronic Disease; D003131:Combined Modality Therapy; D003646:Debridement; D005839:Gentamicins / Q000627:therapeutic use*; D006801:Humans; D008768:Methylmethacrylates / Q000627:therapeutic use*; D010019:Osteomyelitis / Q000188:drug therapy* / Q000601:surgery
chemical_list: D000900:Anti-Bacterial Agents; D005839:Gentamicins; D008768:Methylmethacrylates; C030159:gentamicin-polymethylmethacrylate bead