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 Table of Contents  
ORIGINAL ARTICLES
Year : 2022  |  Volume : 37  |  Issue : 2  |  Page : 50-54

To evaluate the efficacy of antibiotic-coated intramedullary locking nail in the compound fracture of tibia


1 Department of Orthopaedics, S.N. Medical College, Agra, Uttar Pradesh, India
2 Department of Orthopaedics, M.L.N. Medical College, Prayagraj, Uttar Pradesh, India

Date of Submission14-Aug-2022
Date of Acceptance06-Sep-2022
Date of Web Publication19-Oct-2022

Correspondence Address:
Shailesh Kumar
Department of Orthopaedics, M.L.N. Medical College, Prayagraj, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jbjd.jbjd_17_22

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  Abstract 

Introduction: Soft tissue with skeletal infections remains a big problem for orthopaedic surgeons. Bone provides a unique milieu for bacteria, with low vascularity and turnover rate. Biofilm-forming bacteria cause most orthopaedic trauma infections. When biofilm is formed, it protects the microorganism from antimicrobial treatment thus leading to chronic infections. Antibiotic-coated interlocking nail locally releases gentamycin + PDLLA at initial high concentrations followed by a period of constant release. The biodegradable polymer (PDLLA) is excreted from the body through the tricorboxylic acid cycle cycle, combined with gentamycin for sustained release. Materials and Methods: This was a prospective interventional study conducted between September 2018 and August 2020. In this period, we analyzed the hospital records to find out the cases treated by antibiotic-coated intramedullary locking nails. A total of 30 cases of compound tibia fracture were included in our study. Patients were routinely followed at definite intervals and specifically assessed for radiographic and functional evaluation by using the RUST score. Results: Out of 30 patients, radiological union at 6 months using the RUST score was 4 in 10.00% patients, 8 in 13.33% patients, 10 in 23.33% patients and 12 in 53.33% patients and final functional outcome was “excellent” in 53.33% patients, “good” in 23.33% patients, “fair” in13.33 % patients and “poor” in 10.00% patients. Conclusion: Antibiotic-coated tibia interlocking nail yields good functional outcomes with fewer complications in these fractures. Antibiotic tibia interlocking nail is a good treatment option and should be used whenever indicated.

Keywords: Antibiotic-impregnated nail, compound fractures of a long bone, RUST score


How to cite this article:
Pal CP, Dinkar KS, Kapoor R, Kumar S, Verma A, Patel J. To evaluate the efficacy of antibiotic-coated intramedullary locking nail in the compound fracture of tibia. J Bone Joint Dis 2022;37:50-4

How to cite this URL:
Pal CP, Dinkar KS, Kapoor R, Kumar S, Verma A, Patel J. To evaluate the efficacy of antibiotic-coated intramedullary locking nail in the compound fracture of tibia. J Bone Joint Dis [serial online] 2022 [cited 2022 Nov 29];37:50-4. Available from: http://www.jbjd.in/text.asp?2022/37/2/50/358796




  Introduction Top


Muscular and skeletal infections remain a great challenge for orthopedic surgeons and infectious disease specialists. Bones facilitate a unique environment for bacteria, with a decreased turnover rate and vascularity. Biofilm-forming bacteria cause most orthopedic infections.[1] Biofilm is made of a matrix of polysaccharides and proteins. When the biofilm is formed, it protects the microorganism from antimicrobial treatment, thus leading to chronic infections. To avoid biofilm-related chronic infection, four principles given by Cierny and DiPasquale[2] must be noted:

  • A. adequate surgical debridement,


  • B. fracture stabilization,


  • C. covering of adequate soft tissue, and


  • D. good antibiotic coverage.


In healthy bones, the normal concentration of antibiotics might be less than 20% of blood levels and antibiotic exposure is further decreased by biofilms, which inhibit penetration. The optimal method of debridement of intramedullary infections is to ream the medullary canal with reamers, after that it revascularizes the bone in approximately 4 weeks. Therefore, even the use of prolonged antibiotic drugs in local bone tissue does not reach bactericidal concentrations and thus does not affect bacterial growth. Despite advances in antibiotics and operative treatment, the infected compound remains difficult to treat, with considerable morbidity and healthcare costs. Contributing factors for the persistence of the infection are the presence of poorly vascularized tissues, the presence of bacteria to bone and implants, and a slow replication of bacteria. Compound fractures with infection present with the double problem of controlling infection and providing adequate stability.

Most compound fractures are seen in long bones, especially the tibia. In recent years, the treatment of fractures of the tibia shaft has become one of the most controversial subjects in orthopedic surgery. Many orthopedic surgeons are advising a primary non-surgical approach for the management of these fractures due to high rates of infection and failure of fixation.[3] Due to long bed rest and associated socio-economic impact caused by these fractures, there has been constant advancement in treatment, which reduces the period of hospital stay and rate of contamination also. Conservative methods are no longer acceptable to the patients and the community, particularly where the results are marred by high rates of joint stiffness, shortening, and malunion. The treatment of open tibial fractures is the most challenging orthopedic situation faced by surgeons instead of major advances in fracture fixation, soft tissue treatment, and good antibiotic coverage.

So this has led over the years to a number of different forms of internal fixation techniques such as a rush nail or K-nailing, interlocked intramedullary nailing, and compressive locking plating, which are done for selected compound fractures especially as a modern surgical technique like antibiotic-impregnated intramedullary nailing. For maintaining a good bone surface, to prevent resistance against infection, and to provide the best surgical techniques for early bone healing and stability while using any method of internal fixation, emphasis must be on vascular support of bone and soft tissues. Preservation of biological reaction requires minimum exposure, careful handling of fracture, and particularly the least damage to the periosteum, which is the major blood supply to the bone after the fracture. As an application of a compression plate requires the dissection of soft tissue over a wide area, it damages one of the better sources of blood supply to the bone that is the periosteum, which is not in the case with the medullary devices, so these have not been preferred as a treatment of shaft fractures. This form of internal fixation by compressive plating has become the treatment of choice for closed fractures of the tibial shaft in adults 4 cm upper and 4 cm distal part of the tibia. Most of the grade 1 and grade 2 open fractures can be safely and effectively treated by delayed interlocked nailing after healing of the wound. Antibiotic-impregnated interlocking nail (gentamycin+PDLLA) released gentamycin locally at initial high concentrations, followed by a period of constant release and systemically,[4] extremely low concentrations are detectable: initially highest concentration local up to 200 µg/mL for the first 3–4 days (prevents and destroys colonization) and then sustained release for 4–6 weeks. The biodegradable polymer (PDLLA) is excreted from the body through the Krebs cycle (or tricorboxylic acid cycle), combined with gentamycin for programmed release.

The purpose of this study was to assess the functional outcome of the treatment of compound fracture of the tibia using an antibiotic-coated intramedullary interlocking nail in terms of infection control, radiological union, and its complications.


  Materials and Methods Top


A prospective study on 30 antibiotic-coated intramedullary locking nails were conducted between September 2018 and August 2020. The patients were selected from those attending emergency department and OPD of Orthopedics and fulfilling the inclusion criteria. Inclusion criteria of this study were those patients >18 years of age having compound tibia shaft fractures amenable for intramedullary nailing and Gustilo type I, II, and type III A. Patients excluded from our study were

  • Patients not fit for surgery,


  • Breast-feeding, pregnant, or planning to become pregnant,


  • Fracture with neurovascular involvement,


  • Immunocompromised (diabetes or HIV, etc.),


  • Patients suffering from neuropathy and known allergy to a used antibiotic.


  • Initial management of fresh injuries was started at emergency services. A detailed history regarding mode and mechanism of injury was taken before the injury. This was followed by standard emergency assessment, examinations, and investigations as required. Open fractures were classified as per Gustilo and Anderson classification. They were treated by the wound toilet, debridement, primary suturing (where possible), antibiotics, calcaneal skeletal traction with Denham’s pin, and limb elevation [on Bohler Braun frame (for reducing tissue edema)]. When skin condition improved, patients were posted for surgery. Cultures reports were obtained before starting the treatment. X-rays were done to know the level and type of fractures. If the pus cultures were sterile, then the patients were planned for surgery.

    All the patients in this study were operated on under spinal anesthesia. The affected limb of the patient was painted and draped. Skin incision extended about 3 cm along the medial border of the patellar tendon and extended from the tibial tubercle in a proximal direction at the anterior aspect of the knee. Patellar tendon incised longitudinally in line with the medullary cavity, entry point created with awl and fracture was reduced, and a guide wire was inserted under fluoroscopic guidance. The medullary cavity was reamed starting from a small size reamer. The medullary cavity reamed 1 mm size larger than the intended nail. A nail of the appropriate size was inserted. The guide wire was removed and proximal and distal locking screws were inserted. Patellar tendon was repaired and paratenon sutured. Subcutaneous tissue and skin were closed.

    Implant is to be used with the antibiotic-coated intramedullary interlocking nail with gentamycin-eluting property. The implant was impregnated with gentamycin and biodegradable carrier D, L-lactide. The total drug amount in one interlocking nail was approximately 100 mg. The surgical procedure was performed with standard practices and used good antibiotic coverage to treat soft tissue injuries. Gentamycin has a broad spectrum of action and active against Escherichia coli, Klebsiella, Enterobacter, Serratia, Proteus, Actinobacter, Pseudomonas, and Staphylococcus. Their bactericidal action is dependent on concentration. Side effects related to the antibiotic are ototoxicity, renal toxicity, and neuromuscular blockade.

    Post-operatively, the limb was elevated over a pillow; appropriate antibiotics were given for 5 days along with analgesics and anti-inflammatory medicines. After anaesthesia effects subsided and pain-relieving ankle mobilization exercises, quadriceps exercises, and knee-bending exercises were started. Good quality anteroposterior and lateral radiographs of the operated limb were taken. Stitches were removed on the 14th post-operative day. The patient was taught for non-weight-bearing walking with axillary crutches or walkers and discharged along with the advice of continuing physiotherapy at home. Patients were called in the OPD for further follow-up at 1, 2, 3, and 6 months. The condition of the operated leg was reassessed, and standard AP and lateral X-rays were taken at each visit. Partial weight bearing was allowed at 8–12 weeks after the signs of the union in the radiographs. Full weight bearing was allowed only when the fracture was completely united radiologically.


      Results Top


    Of the 30 patients treated, all cases were fresh fractures and compounds with different grades of Gustilo-Anderson classification. As per inclusion criteria, only up to grade IIIA fractures were included in the study. Compound grade IIIB and grade IIIC fractures were excluded from the study. Out of the 30 patients studied, 46.67% of the patients had grade 1 compounding, 46.67% patients had grade II, and 6.66% patients had grade III fractures. This is shown in [Table 1].
    Table 1: Distribution of cases according to Gustilo-Anderson classification

    Click here to view


    Out of the 30 patients, in 10 patients wound healed in 1–2 weeks, in 6 patients 3–4 weeks, 7 patients took 5–6 weeks, 5 patients took 6–7 weeks, and in 2 patients wound did not heal. This has been depicted in [Figure 1].
    Figure 1: Average time of wound healing

    Click here to view


    Out of the 30 patients, radiological union at 6 months (RUST score) was 4 in 3 patients, 8 in 4 patients, 10 in 7 patients, and 12 in 16 patients. This has been depicted in [Figure 2].
    Figure 2: RUST score at 6 months during follow-up

    Click here to view


    In our study, the final functional outcome was assessed and the result was graded as excellent, good, fair, and poor. This has been depicted in [Table 2].
    Table 2: Final functional outcomes at 6 months during follow-up

    Click here to view


    Out of the 30 patients, 2 patients had an infection and 1 patient had non-union at 6 months during follow-up. No neurovascular complications occurred.


      Discussion Top


    Management of open tibial shaft fractures has been a therapeutic challenge. The goal of an orthopedic surgeon is to reduce the rate of infection, facilitate fracture healing after surgical treatment of tibial shaft fractures, and avoid complications. Many techniques have been used since the past few years for fixing these fractures, with variable merits and demerits of every technique. All of these techniques have advantages and disadvantages, and there is no uniform consensus regarding the management of these fractures. In stable internal fixation with an intramedullary nail, we started an early movement of adjacent joints and rehabilitation, thus preventing the frequent problem of joint stiffness. Thus for stable fixation with the early restoration of daily function, antibiotic-coated intramedullary nailing is the best treatment option. It also aids in good wound care, early union, and low infection rates. The purpose of this study was to evaluate the outcomes of antibiotic-impregnated intramedullary locking nails in the compound shaft tibia fractures with complications and compare the results with those in the literature.

    The mean age that sustained open shaft tibia fracture was 37.47 years with a standard deviation of ±11.17. It was comparable with the mean age of 39.5 years in the study by Khaled Hamed et al.[5] The mean age of the patients was 35.4 years in the study by Mantri et al.[6] The mean age of the patients was 47.7 years in the study by Fuchs et al.[7] The mean age was 33.4 years in the study by Pratap et al.[8] Thus we can say that the younger and more active segment of our society sustains these fractures. In our study, a total of 30 patients were studied, out of which 24 (80.00%) patients were males and the rest 6 (20.00%) patients were females. There were 23 (92%) male patients and 2 (08%) female patients in the study by Mantri et al.[6] There were 20 (80%) men and 5 (20%) women in a study by Pratap et al.[8] Thus results of our study are comparable. In our study, a total of 30 patients were studied, out of which 27 (90.00%) patients had fractures due to road traffic accidents and 3 (10%) patients were injured due to other causes. While studying 39 cases of open tibial fractures, Court Brown et al.[9] recorded 26 (66.66%) cases due to road traffic accidents and 13 (33.33%) cases due to other causes. In a study by Pratap et al.[8] 20 (80%) cases were due to road traffic accidents and 5 (20%) cases were due to other causes. Thus it can be said that road traffic accidents are the most common causes of open shaft tibial fractures, and the results of our study are more or less comparable with the literature.

    In our study of 30 patients, 14 (46.67%) patients had compound grade-I, 14 (46.67%) patients had grade-II, and 2 (06.66%) patients had grade-III fractures. In a study by Khaled Hamed et al.,[5] 8 (72.72%) patients had Gustilo type I fracture, whereas 3 (27.2%) patients had type II fracture. In our study, union was achieved by 29 (96.67%) patients and 1 (03.33%) underwent non-union. In a study by Bhanu et al.,[8] out of 25 patients, no non-union occurred, 2 (8%) patients underwent delayed union which after dynamization united successfully. This shows that the results of our study are comparable with the literature. In our study, 28 (93.33%) patients were able to bear weight after 6 months of surgery and 2 (06.67%) patients were unable to bear weight. In a study by Fuchs et al.,[7] after 6 months of surgery, out of 19 patients, the majority of patients 13 (68.42%) could bear full weight and the remaining 6 patients (31.57%) could bear partial weight. In a study by Pratap et al.,[8] all 25 patients were able to bear weight after 6 months of surgery. This is similar to studies in the literature.

    In our study, 2 (06.67%) patients had an infection after surgery. In the study by Pratap et al.,[8] 2 (8%) patients got infected out of 25 patients. In a study by Fuchs et al.,[7] 1 (5.26%) patient got infected out of 19 patients. Thus, we can say that the results of our study matched with the other studies. In this study, average time of wound healing was 4.11 weeks. In a study by Mantri et al.,[6] the average time of wound healing was 4.1 weeks. This is similar to other studies in the literature. In our study, a total of 16 (53.33%) patients had excellent outcomes, 11 (36.66%) patients had good-to-fair outcomes and only 3 (10.00%) patients had poor outcomes. In a study by Mantri et al.,[6] 5 (20%) patients had excellent outcomes, 19 (76%) patients had good to fair outcomes, and only 1 (4%) patient had poor outcome. Thus we can say that these results are more comparable with other literatures. Thus, in the end, we can conclude that antibiotic-coated tibia interlocking nail achieves good functional outcomes in the treatment of open shaft tibia fractures with fewer complications.


      Conclusion Top


    Open shaft tibia fractures are usually affecting the middle age group of 20–40 years of age. The incidence of these fractures is higher in males because males are more commonly involved in outdoor activities. The most common mode of injury is road traffic accidents. Thus usually they are a result of high energy trauma. Surgeons should wait for tissue edema to settle and skin condition to become good enough to post the patient for surgery, on an average within 7–14 days. To avoid complications, full weight-bearing should only be allowed after the radiological union. Most of the patients could bear weight without pain after 6 months. Most of the wounds healed within 3–7 weeks. Infection is the usually encountered complication in these fractures after surgery, but by respecting and gently handling the tissue and good wound care, this complication can be avoided. Other complications include non-union and malunion which are uncommon. Antibiotic-coated tibia interlocking nail yields good functional outcomes with fewer complications in these fractures. Antibiotic tibia interlocking nail is a good treatment option and should be used whenever indicated.

    Financial support and sponsorship

    Nil.

    Conflicts of interest

    There are no conflicts of interest.



     
      References Top

    1.
    Stoodley P, Ehrlich GD, Sedghizadeh PP, Hall-Stoodley L, Baratz ME, Altman DT, et al. Orthopaedic biofilm infections. Curr Orthop Pract 2011;22:558-63.  Back to cited text no. 1
        
    2.
    Cierny G III, DiPasquale D Treatment of chronic infection. J Am Acad Orthop Surg 2006;14:S105-10.  Back to cited text no. 2
        
    3.
    Richards RG, Harris L, Schneider E, Haas NP Infection in fracture fixation: From basic research, to diagnosis, to evidence-based treatment. Injury2006;37:169 p.  Back to cited text no. 3
        
    4.
    Schmidmaier G, Wildemann B, Stemberger A, Haas NP, Raschke M Biodegradable poly(D,L-lactide) coating of implants for continuous release of growth factors. J Biomed Mater Res 2001;58:449-55.  Back to cited text no. 4
        
    5.
    Pinto D, Manjunatha K, Savur AD, Ahmed NR, Mallya S, Ramya V Comparative study of the efficacy of gentamicin-coated intramedullary interlocking nail versus regular intramedullary interlocking nail in Gustilo type I and II open tibia fractures. Chin J Traumatol 2019;22:270-3.  Back to cited text no. 5
        
    6.
    Mantri D, Soni SK, Sonkar DK Evaluation of role of antibiotic cement impregnated intramedullary nail in infected long bone fractures. Orthopaedic J MP Chap 2015;21:36-40.  Back to cited text no. 6
        
    7.
    Fuchs T, Stange R, Schmidmaier G, Raschke MJ The use of gentamicin-coated nails in the tibia: Preliminary results of a prospective study. Arch Orthop Trauma Surg 2011;131:1419-25.  Back to cited text no. 7
        
    8.
    Pratap B, Gaur A, Joshi V Functional outcome of antibiotic coated interlocking intramedullary nail in open tibia diaphyseal fracture. Int J Orthop Sci 2019;5:803-7.  Back to cited text no. 8
        
    9.
    Whelan DB, Bhandari M, Stephen D, Kreder H, McKee MD, Zdero R, et al. Development of the radiographic union score for tibial fractures for the assessment of tibial fracture healing after intramedullary fixation. J Trauma 2010;68:629-32.  Back to cited text no. 9
        


        Figures

      [Figure 1], [Figure 2]
     
     
        Tables

      [Table 1], [Table 2]



     

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