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.

Abstract

OBJECTIVES:

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.

DESIGN:

A prospective, randomized clinical trial.

SETTING:

A university-affiliated teaching hospital.

PATIENTS/PARTICIPANTS:

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).

INTERVENTION:

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

MAIN OUTCOME MEASUREMENTS:

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.

• Authors: Michael D McKee, Esther A Li-Bland, Lisa M Wild, Emil H Schemitsch
• Journal: Journal of orthopaedic trauma (J Orthop Trauma) Vol. 24 Issue 8 Pg. 483-90 (Aug 2010) ISSN: 1531-2291 [Electronic] United States
• PMID: 20657257 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Bone Cements
• Bone Substitutes
• Drug Implants
• Tobramycin

Topics

• Absorption
• Adult
• Aged
• Anti-Bacterial Agents (administration & dosage)
• Bone Cements (therapeutic use)
• Bone Substitutes (administration & dosage)
• Chronic Disease
• Drug Implants (administration & dosage)
• Female
• Fractures, Ununited (drug therapy, surgery)
• Humans
• Male
• Middle Aged
• Osteomyelitis (drug therapy, surgery)
• Prospective Studies
• Tobramycin (administration & dosage)
• Treatment Outcome
• Young Adult