Background The management of complex orthopedic infections usually includes a prolonged course of intravenous antibiotic agents. We investigated whether oral antibiotic therapy is noninferior to intravenous antibiotic therapy for this indication. Methods We enrolled adults who were being treated for bone or joint infection at 26 U.K. centers. Within 7 days after surgery (or, if the infection was being managed without surgery, within 7 days after the start of antibiotic treatment), participants were randomly assigned to receive either intravenous or oral antibiotics to complete the first 6 weeks of therapy. Follow-on oral antibiotics were permitted in both groups. The primary end point was definitive treatment failure within 1 year after randomization. In the analysis of the risk of the primary end point, the noninferiority margin was 7.5 percentage points. Results Among the 1054 participants (527 in each group), end-point data were available for 1015 (96.3%). Treatment failure occurred in 74 of 506 participants (14.6%) in the intravenous group and 67 of 509 participants (13.2%) in the oral group. Missing end-point data (39 participants, 3.7%) were imputed. The intention-to-treat analysis showed a difference in the risk of definitive treatment failure (oral group vs. intravenous group) of −1.4 percentage points (90% confidence interval [CI], −4.9 to 2.2; 95% CI, −5.6 to 2.9), indicating noninferiority. Complete-case, per-protocol, and sensitivity analyses supported this result. The between-group difference in the incidence of serious adverse events was not significant (146 of 527 participants [27.7%] in the intravenous group and 138 of 527 [26.2%] in the oral group; P = 0.58). Catheter complications, analyzed as a secondary end point, were more common in the intravenous group (9.4% vs. 1.0%). Conclusions Oral antibiotic therapy was noninferior to intravenous antibiotic therapy when used during the first 6 weeks for complex orthopedic infection, as assessed by treatment failure at 1 year. (Funded by the National Institute for Health Research; OVIVA Current Controlled Trials number, ISRCTN91566927.)
Infected nonunion of a long bone continues to present difficulties in management. In addition to treating the infection, it is necessary to establish bony stability, encourage fracture union and reconstruct the soft-tissue envelope. We present a series of 67 infected nonunions of a long bone in 66 patients treated in a multidisciplinary unit. The operative treatment of patients suitable for limb salvage was performed as a single procedure. Antibiotic regimes were determined by the results of microbiological culture. At a mean follow-up of 52 months (22 to 97), 59 patients (88%) had an infection-free united fracture in a functioning limb. Seven others required amputation (three as primary treatment, three after late failure of limb salvage and one for recalcitrant pain after union). The initial operation achieved union in 54 (84%) of the salvaged limbs at a mean of nine months (three to 26), with recurrence of infection in 9%. Further surgery in those limbs that remained ununited increased the union rate to 62 (97%) of the 64 limbs treated by limb salvage at final follow-up. The use of internal fixation was associated with a higher risk of recurrent infection than external fixation.
BackgroundThe Ilizarov technique has been used in the UK for the last 20 years in the management of infected non-union of long bones. This method uses fine wires inserted percutaneously which are attached and tensioned to provide a strong frame construct. The majority of tibial and femoral non unions can be treated successfully by internal fixation. However, an infected non-union of the tibia can prove a difficult problem. The Ilizarov method can prove useful for treating these complex injuries.ObjectivesTo assess whether a new limb reconstruction centre in the UK has comparable results.Patients and MethodsTwelve patients (10 M: 2 F; Avg age 43.3 years) who had an infected tibial non-union between March 2009 and August 2010 treated with the Ilizarov technique. Intervention method was Ilizarov technique and main outcome measures include functional and radiological outcomes assessed using the Association for the Study and Application of Methods of Ilizarov (ASAMI) criteria, American Orthopaedic Foot and Ankle Score (AOFAS) and Visual Analogue Pain scores.ResultsAll twelve patients united. None required amputation. Mean time to union was 46 weeks (range 24 - 70/median 50). The average follow up time was 62 weeks (39 - 164/ median 59). According to the ASAMI score bone/radiological results ten were classed as excellent with the remainder being good. Functionally six were graded as excellent, four as good and two as poor. The average AOFAS score was 83/100 (70 - 90) and pain visual analogue scale (VAS) was two.ConclusionsOur results in terms of ASAMI scores are comparable with the published literature. Furthermore, our return to work is better than most European studies (63%). All our patients said they would have the procedure again. We attribute this success partly to the multidisciplinary approach. We recommend early referral to a dedicated unit if there is any evidence of a non-union.
Surgical debridement and prolonged systemic antibiotic therapy are an established management strategy for infection after tibial fractures. Local antibiotic delivery via cement beads has shown improved outcome but requires further surgery for extraction of beads. OSTEOSET®-T is a resorbable bone void filler composed of calcium sulphate and 4 % tobramycin that is packed easily into bone defects. This is a review of the outcomes of 21 patients treated with OSTEOSET®-T for osteomyelitis of the tibia. This is a retrospective case note and clinical review. In all cases, the strategy was debridement, with removal of any implants, with excision back to bleeding bone. OSTEOSET®-T pellets were packed into any contained defects or the intra-medullary canal with further bony stabilisation (n = 9) and soft tissue reconstruction (n = 7) undertaken as required. Intravenous vancomycin and meropenem were administered after sampling with substitution to targeted antibiotic therapy for between 6 weeks and 6 months. The average follow-up was 15 months. Union rate after tibial reconstruction was 100 %. Wound complications were encountered in 52 %: a wound discharge in the early post-operative period was noted in seven patients (33 %) independent of site of pellet placement. In the 14 cases without a wound leak, five developed wound complications (p = 0.06, Fisher’s exact test) either from delayed wound-healing or pin-site infections. One patient developed a transient acute kidney injury and one refractory osteomyelitis. OSTEOSET®-T is an effective adjunct in the treatment of chronic tibial osteomyelitis following trauma based on the low incidence of relapse of infection within the period of follow-up in this study, but significant wound complications and one transient nephrotoxic event were also recorded.
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