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Bone infection has long been a formidable foe of orthopaedic surgeons. The standard method of treating osteomyelitis generally consists of irrigation and debridement supplemented by pre- and postoperative antibiotics and intraoperative antimicrobial solutions. In the 1970s, Buchholz introduced the concept of local antibacterial therapy in the form of antibiotic impregnated bone cement to treated infected arthroplasties. From this, antibiotic impregnated beads were developed to treat local infections of bone and soft tissue. The advantage of these beads compared with parenteral therapy is that they deliver a high concentration of antibacterial locally while avoiding high systemic concentrations, thus avoiding adverse effects that are often associated with parenteral antibacterial therapy. Additionally, methylmethacrylate bone cement does not significantly affect the immune response of the body. This makes the use of antibiotic-impregnated polymethylmethacrylate (PMMA) beads highly effective either as an alternative to, or in conjunction with, systemic antibiotic treatment of infected arthroplasties, and localised bone and soft tissue infection. This article explores the indications for the use of local therapy as well as any advantages or disadvantages it may have over systemic antibacterial treatment. Additionally, there are important pharmacokinetic considerations for the optimal use of antibacterial agents in the treatment of osteomyelitis.

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.

Fifty-two patients enrolled in the Septopal study of infected nonunions were prospectively examined in a randomized, controlled, closed study. Patients were divided into two groups. Group 1 consisted of 24 patients treated with debridement and intravenous antibiotics for four weeks. Group 2 consisted of 28 patients treated with debridement, gentamicin-polymethylmethacrylate (Septopal) beads, and perioperative broad-spectrum parenteral antibiotics. Both groups were treated with similar methods for reconstruction of the nonunions. The demographics of the two groups were similar. The average patient age in Group 1 was 38.4 years, and in Group 2, 37.1 years. Group 1 included 21 men and three women and Group 2, 23 men and five women. The nonunions in both groups ranged from simple hypertrophic nonunions to atrophic unions to segmental defects. The end results were good in both groups. Twenty patients in Group 1 and 25 patients in Group 2 had their infections successfully arrested (83.3% and 89.3%, respectively). Nonunions were successfully healed in the two groups, with similar results (Group 1, 83.3%; Group 2, 85.7%). Infected nonunions responded equally well to either systemic treatment with long-term intravenous antibiotics or local treatment with gentamicin-polymethylmethacrylate beads.

Fifty-two chronic osteomyelitis patients treated with gentamicin-polymethylmethacrylate (Septopal) antibiotic bead chains were observed retrospectively to explore the relationship between the duration of bead implantation and clinical results. Group A contained 35 asymptomatic patients who had elective bead removal based on protocol, surgeon's preference, and patient variables. Group B consisted of 17 patients who retained the antibiotic beads. The presence or absence of redness, abscess, drainage, pain, or swelling at the wound site was documented for clinical evaluation. Findings indicate that Septopal bead chain implants exhibit higher success (remission) rates with increasing length of duration without increasing the risk of complications.

In a consecutive series of 704 compound fractures, 227 open fractures in 204 patients were managed with the antibiotic bead pouch technique. There were 16 Grade I compound fractures, 83 Grade II fractures, and 128 Grade III open fractures. The mean patient age was 35.25 years (range, 14-87). The Injury Severity Score (ISS) ranged from 9 to 57, with a mean of 15. Porous plastic film is placed over the soft-tissue defect to establish a "closed" bead-hematoma-fracture environment containing high local levels of antibiotic at the fracture site. All patients had serial wound debridements and parenteral systemic antibiotics (cefazolin, tobramycin, penicillin). Bead pouch changes ranged from one to seven per patient (mean, two). During these changes, 1248 cultures were taken, 78 (6.25%) of which were positive in 34 patients. Seventeen patients developed clinical signs consistent with an infection. The wound infection rate was 0% in Grade I open fractures, 1.2% in Grade II compound fractures, and 8.6% in Grade III open fractures. The osteomyelitis rate was 0% in Grade I compound fractures, 2.4% in Grade II open fractures, and 5.5% in Grade III compound fractures. Wound closure was obtained in 134 fractures with delayed primary closure of the skin, in 53 fractures with flap coverage, and in 23 fractures with split-thickness skin graft. Coverage was not completed in 17 wounds, at which time an amputation was performed or death occurred. Time of closure ranged from one to 32 days (mean, 7.1 days).(ABSTRACT TRUNCATED AT 250 WORDS)

Seven hundred four compound fractures (198 [28%] Grade I, 259 [37%] Grade II, and 247 [35%] Grade III) were treated during a seven-year period at the author's institution. One hundred fifty-seven open fractures (22%) (Group A) received systemic antibiotic prophylaxis only, whereas 547 compound fractures (78%) (Group B) were treated with local application of antibiotic beads (tobramycin) in addition to prophylaxis. Fracture grades, age, gender, fracture location, and length of follow-up period were not significantly different between the two groups. All fractures underwent timely irrigation, debridement, and skeletal stabilization. Forty-nine of 704 compound fractures (7%) developed an infection (acute wound infection or chronic osteomyelitis or both). Group A showed an infection rate of 17% (26/157); treatment in Group B resulted in 23 compound fracture infections (4.2%). The difference in the incidence of infection was statistically significant. Comparison of the infection rates in either wound infection or chronic osteomyelitis showed a trend toward decreased rates in Group B versus Group A throughout all fracture grades. However, by subdivision into the fracture grades, only the IIIB types had a statistically significant decrease of infection in Group B versus Group A; the wound infection rate was 39% (9/23) in Group A and 7.3% (7/96) in Group B. The rate of chronic osteomyelitis was 26% (6/23) in Group A and 6.3% (6/96) in Group B. Prophylactic use of antibiotic-laden PMMA beads in addition to systemic antibiotics was of benefit in preventing infectious complications in compound fractures, in particular in Type IIIB open fractures.

A consecutive series of 119 type III B compound fractures in 103 patients was treated at the University of Louisville from May 1983 to May 1989. All patients had timely irrigation of their wounds, serial wound debridements, external skeletal stabilization and parenteral systemic antibiotics (penicillin, cefazolin, tobramycin). 96 open fractures were managed with the supplemental local use of tobramycin-PMMA-beads. There were 13.5% wound infections and 10.1% osteomyelitis observed. The additional local antibiotic therapy was of significant (p less than 0.001, p less than 0.025) benefit to lower both infectious complications. The amputation rate was overall 5%, 9.7% for the lower leg. Four patients died due to multiple trauma.

In a consecutive series of 222 compound fractures treated at the University of Louisville Level I Trauma Center from November 1984 to January 1987, 21 severe compound tibia shaft fractures in 20 patients were managed with the antibiotic bead pouch technique. There were 5 tibia shaft fractures and 16 tib-fib fractures. There were 9 type II and 12 type III (4 III A and 8 III B) open tibias. The patients' ages ranged from 16 to 50 years; the mean age was 29 years. There were 19 men and 1 woman. The Injury Severity Score (I.S.S.) ranged from 9 to 34; the mean I.S.S. was 14.4. Porous plastic film (Opsite) is placed over the soft tissue defect to establish a "closed" bead - hematoma - fracture environment containing high local levels of antibiotic at the fracture site. All patients had external skeletal fixation, serial wound débridement, and parenteral systemic antibiotics (cefazolin, penicillin, tobramycin). An aggregate of 46 bead pouch changes were performed in the 21 tibia fractures. During these changes, 86 cultures were taken, 5 of which were positive. One patient developed a wound infection, which was caused by tobramycin-resistant Pseudomonas and Enterococcus. No cases of osteomyelitis were observed at the fracture site. Wound closure was obtained in 9 fractures with delayed primary closure, and in 12 fractures with flap coverage and/or split thickness skin grafting. All patients underwent autogenous cancellous bone grafting after wound closure was established. The mean follow-up was 26 months (range 13-43 months). At final follow-up, 4 results were rated excellent, 11 good, 3 fair and 3 poor.(ABSTRACT TRUNCATED AT 250 WORDS)