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 Table of Contents  
Year : 2019  |  Volume : 11  |  Issue : 1  |  Page : 16-20

Role of antibiotic-impregnated cement intramedullary nail in infected nonunion of long bone diaphyseal fractures

Department of Orthopaedics, Jhalawar Medical College, Jhalawar, Rajasthan, India

Date of Web Publication19-Aug-2019

Correspondence Address:
Dr. Vikas Chavan
Room No. 312, PG Boys Hostel, Jhalawar Medical College, Jhalawar - 326 001, Rajasthan
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jotr.jotr_4_19

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Introduction: Infected nonunion of long bones is a chronic and debilitating disorder to manage. The problems in treating them are infection, instability, and deformity. This study aims to evaluate the effectiveness of antibiotic-impregnated intramedullary nail as a management for infected nonunion of long bones. Materials and Methods: A total of 12 cases of infected nonunion of long bones (10 – tibia and 2 – femur) without bone loss and age group of more than 18 years are treated using antibiotic cement-coated k-nail. Antibiotics used are vancomycin 4 g and clindamycin 2 g. The average duration of retention of antibiotic nail was 24 weeks. Results: At follow-up, infection was controlled in 90% of cases. Bony union achieved in 8 out of 12 cases (66%). Rest 4 cases required further additional procedures. Recurrence of infection occurred in two cases. Conclusions: This is a very effective and economical with better patient compliance. This method achieves infection control, promotes bone union, and mechanical stability.

Keywords: ACIINs, Antibiotic coated nails, infected nonunion, k-nail, non-union

How to cite this article:
Chavan V, Bairwa VK, Jhanwar P, Bohra AK. Role of antibiotic-impregnated cement intramedullary nail in infected nonunion of long bone diaphyseal fractures. J Orthop Traumatol Rehabil 2019;11:16-20

How to cite this URL:
Chavan V, Bairwa VK, Jhanwar P, Bohra AK. Role of antibiotic-impregnated cement intramedullary nail in infected nonunion of long bone diaphyseal fractures. J Orthop Traumatol Rehabil [serial online] 2019 [cited 2020 Aug 7];11:16-20. Available from: http://www.jotr.in/text.asp?2019/11/1/16/264731

  Introduction Top

Infected nonunion of long bones is a chronic and debilitating disorder to manage in terms of cost- and time-effective treatment.[1] Various factors which cause infected nonunion of long bone fracture is generally inherent to the fracture, such as compound fracture, loss of soft tissue or bone, severe comminution and gross displacement, insufficient immobilization, infection after internal or external fixation, chronic osteomyelitis, and surgical debridement of infected bone.[2]

According to Gustilo,[3] problems associated with infected nonunion are avascularity at the fracture site due to scarring and cicatrization as a result of multiple surgeries, drug resistance to pathogenic organisms, restriction of neighboring joint motion, and gap nonunion. Infection creates an unfavorable environment for fracture healing, especially when it is associated with mechanical instability.[4] Excellent knowledge of the pathophysiology of lesions and the biomechanical concept of fixation techniques is essential for better functional outcome.[5]

In earlier days, infected nonunions were treated by a staged protocol; the first stage comprises debridement with or without antibiotic cement bead insertion and systemic antibiotics to convert an infected nonunion to an aseptic nonunion. The second stage is performed to achieve stability by either external or internal fixation with or without bone grafting.[2],[6],[7],[8],[9],[10]

Single-staged procedures such as debridement and application of external fixator or use of antibiotic cement-impregnated intramedullary nails (ACIINs) have been described.[2] However, a high prevalence of pin-site infections, muscle contractures, and joint stiffness has been observed in association with external fixation. The use of an antibiotic cement-impregnated IM nailing for infected nonunion of tibia and femur fractures has been well documented in the literature.[11],[12],[13],[14],[15],[16],[17],[18] The cement nail provides stability across the fracture site, unlike cement beads, and osseous stability is important in the management of an infected nonunion.[17],[18]

Local antibiotic therapy is a useful technique that results in high local concentrations of antibiotics and is associated with fewer side effects. Broad-spectrum antibiotics such as clindamycin and vancomycin are used in our study. Two antibiotics with bone cement widen the spectrum of activity and also enhance the elution properties of the two antibiotics.[5],[19]

ACIINs provides a high concentration of antibiotics locally, fills dead space, gives good mechanical stability at fracture site, and thereby promotes bone healing.[12],[14] Thus, ACIINs provides all the advantages of cement beads.[5] This study was undertaken to evaluate the usefulness of ACIIN in case of infected nonunion of long bones.

  Materials and Methods Top

This study conducted from June 2017 to June 2018. Inclusion criteria were infected nonunion of the tibia and femur with no evidence of union and without bone loss. Patients with the radiologically visible or intraoperative finding of gap nonunion of >1 cm, patients with multiple medical comorbidities and those with hypersensitivity to antibiotics were excluded from the study. All patients were thoroughly investigated and evaluated by clinical and radiological means.

Twelve cases of infected nonunion were included in our study for treatment of infected nonunion and to evaluate the results. There were 10 tibia and 2 femur cases [Figure 1] above the age of 18 years, were treated using antibiotic cement-coated k-nail in cases of primarily infected fracture (in which no primary intervention had been done) and secondarily infected fractures (in which the prior intervention was done and got infected) with no bone defect. Preoperative investigations like complete blood count, erythrocyte sedimentation rate, C-reactive protein, culture and sensitivity of pus discharge are done in all patients.
Figure 1: Number cases involving femur and tibia in the study

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Management is based upon:

  • Radical thorough debridement locally at fracture site and thorough reaming and lavage of the medullary canal
  • Antibiotic-impregnated cement coating over nail
  • Mechanical stability by Intra-medullary k-nail.

Operative procedure

After preoperative investigation, patients were posted for surgery. Under regional or general anesthesia, adequate exposure of the nonunion site and implant removal (if present) were done. The first step involves thorough debridement of the infected bone and soft tissues and copious lavage. The goal of thorough and meticulous debridement was done to achieve the viable environment at and around the fracture site. Excision of sinus tracts and of scarred and infected soft tissue was performed to achieve active bleeding of the area present over the fracture ends. Implants were removed, as a biofilm is formed around the implant by the bacteria that protect them. Infected avascular bony ends were resected till the punctate bleeding surface was obtained at the cut end, which is known as Paprika sign.

After thorough debridement, limb was prepared again and simultaneously antibiotic-impregnated cement nail was prepared. Antibiotic cement was prepared manually on a separate trolley with 40 g of polymethylmethacrylate cement mixed with 4 g of vancomycin powder and 2 g of clindamycin cap [Figure 2]. Monomer solution was added to this powder and mixed until the material acquired viscous consistency. K-nails of diameter 2–3 mm less than the last reamer width were chosen. Manual application of the cement was done in a uniform smooth layer excluding the eye to facilitate easy removal later [Figure 3]. After adequate setting and hardening, the nail was inserted into the medullary canal and wound closure done in layers.
Figure 2: Materials used – PMMA, antibiotics (Vancomycin and Clindamycin), k-nail

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Figure 3: Manually prepared antibiotic cement coated k-nail

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Postoperative protocol

Postoperatively, the patients were started on intravenous antibiotics as per the sensitivity profile. The wound was inspected on 2nd or 3rd day, and dressing was done regularly if needed. Active and passive range of motion exercises and nonweight-bearing mobilization was encouraged. Clinical and radiological features were used to assess the progress of bony union at 4 weeks interval till union was sound. As soon as the wound healed, a patellar tendon-bearing cast was applied in case of tibia, walker is advised in case of femur and gradual full weight bearing was permitted. The cast was changed every 4 weeks and continued till union was confirmed with the clinicoradiological assessment. Physiotherapy for regaining ankle and knee mobility were advised until the range of motion was satisfactory.

  Results Top

Twelve cases of infected nonunion were included in our study for treatment with antibiotic-impregnated cement nail and to evaluate the outcome. The average duration of follow-up was 24 weeks ranging from 20 to 28 weeks. The most common microorganism isolated in our study was Staphylococcus aureus.

The outcome of the study analyzed in terms of fracture union, infection control, and failure. Success cases are those where complete clinical and radiological union with infection control occurred. Fair cases are those where infection control was achieved without union. Failure cases are those where nonunion failed to achieve union without control of infection.

Out of the 12 patients who underwent antibiotic-coated cement nail, 11 patients had excellent infection control at 6 weeks follow-up. Infection control finally achieved in the last patient by 10–12 weeks. Among these 11 patients, 8 had signs of radiological fracture callus and were continued with the nail in situ till complete bony union [Figure 4].
Figure 4: Outcome

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Rest of the 4 patients who had no evidence of radiological callus at 12 weeks of postsurgery were treated with additional surgical procedures such as bone marrow infiltration, plasma-rich protein infiltration, or bone grafting.

Case 1

40 year old male patient presented to the hospital with pus discharge from proximal and distal part of right leg, who was operated 14 months back in Bhopal for fracture tibia right side [Figure 5].
Figure 5: (a) Preoperative X-ray. (b) Postoperative X-ray. (c) Clinical picture of patient standing with healed sinus

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Case 2

35 year old male patient presented with discharging sinus from right thigh. Past history of fracture right femur for which interlock intramedullary nailing was done 2 years back [Figure 6].
Figure 6: (a) Preoperative X-ray. (b) Postoperative X-ray

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  Discussion Top

Infected long bone fractures require procedure to control infection, provide stability, and achieve union.[20] Traditionally, infected nonunion have been managed using two-step procedure to control the infection first and subsequently to treat the nonunion.[21] Surgical debridement and delivery of antibiotic locally and systemically are used to control the infection. Local antibiotic therapy results in high local concentration of antibiotic with minimum systemic level.[20]

The concept of local delivery of antibiotics to manage osteomyelitis or open fractures was developed in the early 20th century in an effort to increase local antibiotic concentrations.[22] Various delivery vehicles for antibiotics are currently available, including PMMA cement and several types of biodegradable bone fillers. PMMA cement, however, is the most commonly used and cost-effective delivery material. After being mixed into the PMMA cement, antibiotics are steadily released from the cement's surface and from cracks and voids in the cement.[23]

The antibiotics that are used for this purpose should have a broad spectrum of activity, should be heat stable, have good elution properties from the cement, and should have low allergenicity. Most of the researchers in the past used a combination of vancomycin with gentamicin or tobramycin.[5],[11],[14],[24],[25] In our study, we used a combination of vancomycin and clindamycin as most of the culture and sensitivity reports from the patients at our center were reporting S. aureus.

Wider surface area of elution allows for high antibiotic concentration along entire length of the bone. This is essential as necrotic and avascular segments are impermeable to systemic parenteral antibiotic therapy. There is a high local concentration of antibiotic even in the presence of extensive scarring and compromised vascularity. Patients with elevated renal parameters can be treated with effective concentration of antibiotic without side effects.[26]

Conventional external fixator or Ilizarov is cumbersome and poor patient compliance. Patient compliance is found good with this method as in external fixator or Ilizarov the apparatus is bulky and prone for pin-tract infection. For this, regular follow-up is not as cumbersome as for external fixator. Postoperative morbidity is less due to early passive mobilization of the limb, and it essentially helps in final rehabilitation.[26]

Why K-nail

  • Cloverleaf shape which holds cement in slot, provides stability and rigidity
  • Slot of k-nail which accommodate good amount of cement.

Paley and Herzenberg in 2002, many researchers have produced good results using this procedure for the treatment of infected nonunion. Paley and Herzenberg studied a small sample of nine cases and reported infection control in all the cases. In the study by Rajesh et al. (2013), infection was controlled in 17 out of 18 cases, and exchange nailing was done for only three cases to achieve bony union. Bhatia et al. (2017) study showed infection was controlled in 19 of 20 (95%) patients. Bone union was achieved in 18 of 20 patients with or without additional procedures.

In our study, infection was controlled in 11 out of 12 of cases (90%). Bony union achieved in 8 out of 12 cases (66%). Rest 4 cases required further additional procedures. Recurrence of infection occurred in two cases and debonding of cement is seen in 1 case [Table 1].
Table 1: Complications - During follow-up

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  Conclusions Top

ACIINs is a good procedure to achieve early infection control, provide stability, and bone union with single-stage procedure in infected long bone fractures without bone gap. In our study, infection was controlled in 90% of cases. Bony union achieved in 8 out of 12 cases (66%). Rest 4 cases required further additional procedures such as bone marrow infiltration, plasma-rich protein infiltration, or bone grafting. Recurrence of infection occurred in two cases and debonding of cement is seen in 1 case [Table 1]. Thus, ACIINs is a very effective and economical method with better patient compliance and satisfaction. This method achieves infection control, promotes bone union, and mechanical stability.

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Conflicts of interest

There are no conflicts of interest.

  References Top

Toh CL, Jupiter JB. The infected nonunion of the tibia. Clin Orthop Relat Res 1995;315:176-91.  Back to cited text no. 1
Patzakis MJ, Zalavras CG. Chronic posttraumatic osteomyelitis and infected nonunion of the tibia: Current management concepts. J Am Acad Orthop Surg 2005;13:417-27.  Back to cited text no. 2
Gustilo RB. Management of infected fractures. Surg Musculoskelet Syst 1990;5:4429.  Back to cited text no. 3
Galfat DR, Agnihotri A, Bansal A. Management of infected nonunion of long bones with antibiotic impregnated cement nail. Natl J Med Dent Res 2013;1:25-32.  Back to cited text no. 4
Dhanasekhar R, Jacob PJ, Francis J. Antibiotic cement impregnated nailing in the management of infected non-union of femur and tibia. Kerala J Orthop 2013;26:93-7.  Back to cited text no. 5
Court-Brown CM. Fractures of the Tibia and fibula. In: Bucholz R, Heckman J, Court-Brown C, Tornetta III P, McQueen M, Ricci W, et al, eds. Rockwood and Green's Fractures in Adults. 6th ed. Philadelphia, PA: Lippincott Williams and Wilkins, 2005. p. 2079-2146.  Back to cited text no. 6
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Sancineto CF, Barla JD. Treatment of long bone osteomyelitis with a mechanically stable intramedullar antibiotic dispenser: Nineteen consecutive cases with a minimum of 12 months follow-up. J Trauma 2008;65:1416-20.  Back to cited text no. 15
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Nizegorodcew T, Palmieri G, Marzetti E. Antibiotic-coated nails in orthopedic and trauma surgery: State of the art. Int J Immunopathol Pharmacol 2011;24:125-8.  Back to cited text no. 17
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Bhatia C, Tiwari AK, Sharma SB, Thalanki S, Rai A. Role of antibiotic cement coated nailing in infected nonunion of tibia. Malays Orthop J 2017;11:6-11.  Back to cited text no. 21
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[PUBMED]  [Full text]  
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Gawali SR, Barve V, Kukale SB, Niravane PV. Successful management of infected tibia IL nail by debridement, lavage, and antibiotic impregnated v-nail. Int J Res Orthop 2016;2:120-6.  Back to cited text no. 26


  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]

  [Table 1]


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