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Aim: Distal tibial injuries combining bone loss, articular destruction and infection can be treated through distraction osteogenesis combined with ankle fusion. Bone transport is not without complications. This study investigates our preliminary results using a retrograde prefabricated gentamicin-coated nail (ETN PROtect®) to treat complications after infected bone defects of the distal tibial were managed by ankle arthrodesis and distraction osteogenesis. Materials and methods: This is a retrospective case series study. All consecutive patients with bone transport complications after ankle arthrodesis and distraction osteogenesis who were subsequently operated on using a retrograde ETN PROtect® nail were analysed. The cases occurred between 2017 and 2020. The primary objective was to report on the resolution of the clinical problem and the risk of deep infection after nail implantation. Results: Five patients have included: two docking site non-unions, two regenerated bone fractures and one hypotrophic regenerated bone. These complications were resolved in all patients (5/5, 100%). A painless, stable and plantigrade ankle arthrodesis was achieved in all cases. No patient developed a local infection or required nail removal (mean follow-up: 35.2 months). The mean LEFS score was 46.8 ± 13.8 and the mean knee ROM was 112 ± 12.7°. All patients tolerated full weight-bearing. All patients were very satisfied with the procedure (mean SAPS score was 93.8 points). Conclusion: The staged retrograde nailing technique using the ETN PROtect® nail may represent an effective and safe treatment for bone transport complications in high-infection-risk patients. Furthermore, the technique allows simultaneous achievement of ankle arthrodesis. The patients had good functional outcomes and were satisfied with the procedure. Clinical significance: This strategy of using retrograde gentamicin-coated tibial nails offers a solution to resolve bone transport complications while simultaneously achieving functional ankle arthrodesis. How to cite this article: Pujol O, Vicente M, Castellanos S, et al. Preliminary Outcomes of a Staged Percutaneous Retrograde Prefabricated Gentamicin-coated Intramedullary Nail to Manage Complications after Ankle Fusion through Tibial Bone Transport. Strategies Trauma Limb Reconstr 2023;18(3):155-162.
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Despite the improvement of surgical techniques surgical site infections (SSIs) still remain clinically challenging in high risk patients undergoing osteosynthesis for tibia fractures. The use of an antibiotic coated implant might reduce the adhesion of bacteria on the implant surface and could therefore reduce the rate of implant-related infection or osteomyelitis. A gentamicin-coated tibia nail was evaluated in a prospective study. Four centers enrolled 100 patients (99 treated) with fresh open or closed tibia fractures, or for non-union revision surgery and followed them for 18 months. Data collected included infection events, radiographs, SF-12, EQ-5D, Iowa Ankle score, and the WOMAC questionnaire. Sixty-eight of the 99 treated patients suffered from a fresh fracture, while in 31 patients, the intramedullary nail was implanted for revision purposes, including non-unions due to infection. Fifteen (22%) of the fresh fractures were GA Type III. The follow-up rate was 87% and 82% at 12 months and 18 months, respectively. Deep surgical site infections occurred in 3 fresh fractures and two in revision surgeries. We did not observe any local or systemic toxic effects related to gentamicin during this study. The use of the antibiotic coated nail is an option in patients with a high infection risk, like open factures or infected non unions, in the prevention of the onset of an implant-related infection or osteomyelitis.
Asunto(s)
Antibacterianos , Clavos Ortopédicos , Fijación Intramedular de Fracturas/métodos , Gentamicinas , Osteomielitis/prevención & control , Infección de la Herida Quirúrgica/prevención & control , Fracturas de la Tibia/cirugía , Adulto , Antibacterianos/administración & dosificación , Femenino , Curación de Fractura/fisiología , Humanos , Masculino , Persona de Mediana Edad , Osteomielitis/etiología , Osteomielitis/microbiología , Estudios Prospectivos , Infección de la Herida Quirúrgica/microbiología , Fracturas de la Tibia/complicaciones , Fracturas de la Tibia/microbiología , Titanio , Resultado del TratamientoRESUMEN
INTRODUCTION: Osteitis is one of the most serious complications in orthopedic surgery. Expert Tibia Nail (ETN) PROtect™ coated with a biodegradable layer of gentamicin-laden polymer was developed for prophylaxis of osteomyelitis. In systemic administration, gentamicin has only a small therapeutic index and serious side effects; it is potentially nephrotoxic as well as ototoxic. It is not yet known if relevant gentamicin concentrations are released into the systemic circulation after implantation of gentamicin-coated nails. In order to evaluate the patients' risks profiles and increase patient safety, we measured gentamicin levels in pre- and postoperative serum samples of patients undergoing implantation of ETN PROtect. METHODS: Twenty-five patients who received ETN PROtect between March 2012 and August 2014 were included in this study. Collection of blood samples occurred before the operation, at weeks 1-4, 3 and 6 months, and up to 1 year after the implantation. Measurement of gentamicin levels in serum samples was performed at the central laboratory of Heidelberg University Hospital. Additionally, laboratory parameters, C-reactive protein, leukocyte number, urea and creatinine concentrations were analyzed in routine controls before and after operating and assessed for systemic side effects. RESULTS: Over the course of this prospective observational study, we were able to determine that gentamicin-coated nails do not release gentamicin into the systemic circulation above the lowest detectable level of 0.2 mg/dL. There were slight increases in the mean inflammation and renal retention markers, but no gentamicin-associated side effects could be linked to implantation. Furthermore, no allergic reactions could be detected during our study. CONCLUSION: Our findings suggest that there is no relevant release of gentamicin into the systemic circulation causing a systemic effect, and serious side effects due to gentamicin-coated tibia nails should not be feared. Postoperative monitoring of renal function does not seem necessary because of the implantation of ETN PROtect.
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BACKGROUND: The successful treatment of atrophic tibia non-unions and tibia non-unions with large bone defects or infections is a major challenge in orthopedic and trauma surgery. This article evaluates the use of the 'diamond concept' using a one-step or two-step procedure according to 'Masquelet technique' in the treatment of atrophic tibia non-unions. METHODS: Between February 2010 and March 2014, 102 patients with atrophic non-unions were treated according to the 'diamond concept' in our center. Ninety-nine were available for follow-up. Forty-nine received a one-step treatment (Group 1, G1) and 50 patients received a two-step treatment according to the 'Masquelet technique' (Group 2, G2). Clinical and radiological parameters were measured preoperatively as well as 4, 6, and 12 weeks and 6 and 12 months postoperatively. In order to evaluate the subjective health of patients, we used the SF-12 questionnaire. Data analysis was performed one year after treatment. RESULTS: The rate of consolidation in G1 was 84% and 80% in G2. The time to heal in G2 was 8.6 ± 2.9 months, which is significantly longer than in G1 being 6.9 ± 3.1 months. In comparison patients in G1/G2 had an average of 3.2/6.7 previous major surgeries. In G1, 4 of 8 patients who did not heal successfully showed positive intraoperative cultures. In G2, 26 patients (52%) initially presented with positive cultures. The results of the SF-12 questionnaire improved in both groups during the postoperative follow-up, but showed no significant differences between groups. In 29 patients a gentamycin-coated nail was used for reosteosynthesis. These patients showed by trend a lower rate of complications at a higher rate of consolidation. CONCLUSIONS: Our study showed that the 'diamond concept' is a suitable method for safely and effectively treating non-unions with large defects or infections. The use of an antibiotic-coated nail provides a therapeutic benefit. For large bone defects of infected non-unions the two-step procedure after Masquelet is an efficient way to eradicate the infection and treat the bone defect successfully.