A prospective, randomized clinical trial comparing an antibiotic-impregnated bioabsorbable bone substitute with standard antibiotic-impregnated cement beads in the treatment of chronic osteomyelitis and infected nonunion.
OBJECTIVE
We sought to compare the effectiveness of an antibiotic-impregnated bioabsorbable bone substitute (BBS, tobramycin-impregnated medical-grade calcium sulfate) with antibiotic-impregnated polymethylmethacrylate (PMMA) cement beads after surgical débridement in patients with chronic nonhematogenous osteomyelitis and/or infected nonunion.


METHODS
A prospective, randomized clinical trial.


METHODS
A university-affiliated teaching hospital.


METHODS
Thirty patients requiring surgical treatment for chronic long bone infection or infected nonunion were included: BBS (15 patients, mean age 44.1 years) PMMA (15 patients, mean age 45.6 years).


METHODS
Patients were randomized to receive either BBS or PMMA to the bone void created by surgical débridement.


METHODS
Eradication of infection, new bone growth, rate of union, repeat operative procedures complications.


RESULTS
Patients were followed for a mean 38 months (range, 24-60 months). One patient was lost to follow-up in each group. In the BBS group, infection was eradicated in 86% (12 of 14) of patients. 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 86% (12 of 14) of patients. Six of eight patients achieved union of their nonunion, and nine patients required 15 further surgical procedures. There were more reoperations in the PMMA group (15 versus seven, P = 0.04), and these procedures tended to be of greater magnitude.


CONCLUSIONS
The results of this preliminary study suggest that, in the treatment of chronic osteomyelitis and infected nonunion, the use of an antibiotic-impregnated BBS is equivalent to standard surgical therapy in eradicating infection and that it may reduce the number of subsequent surgical procedures. A larger, definitive study on this topic is required.
McKee
Michael D
MD
Division of Orthopaedics, St Michael's Hospital and the University of Toronto, Toronto, Ontario, Canada. McKeeM@smh.toronto.on.ca
Li-Bland
Esther A
EA
Wild
Lisa M
LM
Schemitsch
Emil H
EH
D000042:Absorption; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D001843:Bone Cements / Q000627:therapeutic use*; D018786:Bone Substitutes / Q000008:administration & dosage*; D002908:Chronic Disease; D004343:Drug Implants / Q000008:administration & dosage*; D005260:Female; D005599:Fractures, Ununited / Q000188:drug therapy* / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D010019:Osteomyelitis / Q000188:drug therapy* / Q000601:surgery; D011446:Prospective Studies; D014031:Tobramycin / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
D000900:Anti-Bacterial Agents; D001843:Bone Cements; D018786:Bone Substitutes; D004343:Drug Implants; D014031:Tobramycin