Thurs., 10/18/07 Reconstruction, Paper #19, 5:16 pm OTA-2007
•A Randomized Clinical Trial Comparing an Antibiotic-Impregnated Bioabsorbable Bone Substitute to Antibiotic Bone Cement in Chronic Posttraumatic Infection
Michael D. McKee, MD; Esther Li; Lisa M. Wild, RN; Emil H. Schemitsch, MD
(all authors: a-Wright Medical);
St. Michael’s Hospital and the University of Toronto, Toronto, Ontario, Canada
Purpose: We sought to compare the effectiveness of a bioabsorbable bone substitute (BBS) (tobramycin-impregnated medical grade calcium sulfate) to standard antibiotic-impregnated polymethylmethacrylate (PMMA) cement beads when used to fill voids created by surgical débridement in patients with chronic osteomyelitis or infected nonunion.
Methods: 30 patients requiring surgical treatment for chronic long-bone infection were enrolled in a prospective, randomized trial. All patients underwent surgical débridement and irrigation, and were then were randomized to receive either BBS or PMMA in the bone void. The 15 patients in the BBS group comprised 10 males and 5 females with mean age 44.1 years. All had chronic infection, and eight had associated nonunion. The PMMA group included 11 males and 4 females, with mean age 45.6 years. All had chronic infection, and eight had associated nonunion. The number of prior procedures, duration of infection, microbiological profile, bone involved, and duration of infection were similar between the two groups.
Results: Patients were followed for 24 months (range, 18-48 months). One patient was lost to follow-up in each group. In the BBS group, infection was eradicated in 12 of 14 patients (86%). Seven of eight patients achieved union of their nonunion, and five patients underwent seven further surgical procedures. In the PMMA group, infection was eradicated in 12 of 14 patients (86%). 6 of 8 patients achieved union of their nonunion, and 9 patients required 15 further surgical procedures (including 2 amputations). There were more reoperations in the PMMA group (15 vs 7, P = 0.04), and these procedures tended to be of greater magnitude.
Conclusions: Although we recognize that our numbers are small, we believe that our results show that in the treatment of chronic osteomyelitis and infected nonunion, the use of an antibiotic-impregnated bioabsorbable bone substitute is equivalent to standard surgical therapy in eradicating infection, and that it significantly reduces the surgical reintervention rate.
Significance: We believe that an antibiotic-impregnated bone substitute has the potential to reduce the number of procedures and surgical morbidity associated with chronic osteomyelitis and infected nonunion while maintaining a high rate of infection eradication.
If noted, the author indicates something of value received. The codes are identified as a-research or institutional support; b-miscellaneous funding; c-royalties; d-stock options; e-consultant or employee; n-no conflicts disclosed, and *disclosure not available at time of printing.
• The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an “off label” use). ◆FDA information not available at time of printing.