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 Table of Contents  
ORIGINAL ARTICLE
Year : 2023  |  Volume : 6  |  Issue : 1  |  Page : 53-57

Antibiotic-impregnated cement-coated intramedullary nail in primary fixation of compound fractures of tibial shaft – A comparative study with external fixator in terms of infection control


Department of Orthopaedics, Gandhi Medical College, Bhopal, Madhya Pradesh, India

Date of Submission17-May-2022
Date of Decision07-Jul-2022
Date of Acceptance07-Jul-2022
Date of Web Publication27-Dec-2022

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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jodp.jodp_45_22

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  Abstract 


Introduction: Compound tibial shaft fractures are conventionally managed by debridement and primary stabilization by external fixators, followed by definitive fixation after the wound healing; however, many problems such as infection, difficult soft tissue reconstruction, and psychosocial effects encountered. Hence, a technique of antibiotic-impregnated cement-coated intramedullary nailing has been advocated. Aims: The aim of the study is to compare functional and biological outcomes of antibiotic-impregnated cement-coated nail with external fixators. Settings and Design: This was a prospective interventional study. Subjects and Methods: A total of 20 patients with Compound Grade 3A and 3B (Gustilo and Anderson) tibial shaft fractures who met the inclusion and exclusion criteria from January 2020 to June 2021 were selected. Group 1 was operated with antibiotic-impregnated cement-coated nails. Group 2 was operated with external fixators. Clinical and laboratory parameters were used to evaluate infection control. Final follow-up was taken at 6 weeks. Results: The infection rate after nailing was 10% in Group 1 (1/10) and 50% in Group 2 (5/10). Intraoperative time taken for soft tissue reconstruction procedures after primary fixation such as flap cover and skin grafting was comparatively less in Group 1 (mean time – 32 min ± 6.23) compared to Group 2 (51 min ± 5.83). Duration between primary and definite fixation was comparably less in Group 1 (mean duration 5.7 weeks ± 0.45) compared to Group 2 (6.3 weeks ± 1.004). Conclusions: Primary antibiotic-impregnated cement-coated nail is better than external fixator in terms of infection control and providing stability in compound fractures of shaft of tibia.

Keywords: Kuntscher nail, open fractures, Vanco nail


How to cite this article:
Verma R, Sharma S, Solanki C, Prasad A, Rao MG, Tandon S. Antibiotic-impregnated cement-coated intramedullary nail in primary fixation of compound fractures of tibial shaft – A comparative study with external fixator in terms of infection control. J Orthop Dis Traumatol 2023;6:53-7

How to cite this URL:
Verma R, Sharma S, Solanki C, Prasad A, Rao MG, Tandon S. Antibiotic-impregnated cement-coated intramedullary nail in primary fixation of compound fractures of tibial shaft – A comparative study with external fixator in terms of infection control. J Orthop Dis Traumatol [serial online] 2023 [cited 2023 Mar 30];6:53-7. Available from: https://jodt.org/text.asp?2023/6/1/53/365281




  Introduction Top


Compound fractures of shaft of tibia associated with severe soft tissue damage and wound contamination are common these days due to high-energy trauma, most commonly because of motor vehicle accidents, which put the skills of an orthopedic surgeon to test. Mechanical instability and infection at fracture site both create hostile environment for fracture healing.[1]

Conventionally, these fractures are treated with emergency debridement and external fixator application as a temporary modality for stabilization, followed by definitive fixation after soft tissue healing that may take a few weeks to months.[2]

Patients with compound fractures have significantly increased risk of infection after injury. When treated with external fixators, the main problems faced include pin tract infections,[3] difficulty in soft tissue reconstruction, neurovascular impalement, and psychological effect on patient because of cumbersome and unsightly appearance.[4] The pin tract infections make it very difficult for the treating surgeon to decide when and how to do definitive fixation; therefore, they require heavy doses of postoperative systemic antibiotics, causing side effects, and require meticulous pin tract dressing, and even then, infection is difficult to eradicate because pins used for fixation itself become a potential medium for organisms to cause infection. These issues posed enormous psychological and socioeconomic burden on patients, their families, and healthcare facilities.

To overcome all these problems, various modalities of treatment have been used in the past with variable success, i.e., ilizarov ring fixator and intramedullary nail with antibiotic-coated cement beads at fracture site.

Bone infections are most commonly caused by Staphylococcus aureus, which is very notorious for antibiotic resistance in community settings also. To overcome these issues, the higher antibiotics used are vancomycin and linezolid.

From a long time, there was a demand for a single procedure which could tackle all these issues in minimal time frame with minimal cost, easy availability, easy learning curve, and minimal psychosocial impact on patient's health. In the literature, antibiotic-impregnated cement-coated nailing is described as a very effective modality of treatment for infected nonunion of long bones from a long time.[5]

In our study, we used relatively novel technique of antibiotic-impregnated cement-coated intramedullary nail in primary fixation of compound fractures of the tibial shaft and compared it with external fixators with our primary focus on infection control. Antibiotic cement elutes antibiotics locally for a long period and in amount that exceeds the minimum inhibitory concentration (200 times approximately), as compared to systemic route.[6] High antibiotic concentration at primary surgery ensures maintenance of infection free zone near fracture site, which ultimately results in improved wound as well as bone healing. It further helps in improving overall outcome and promotes early definitive fixation as compared to traditional methods.[7] Use of intramedullary nail provides improved biplanar stability from day 1 across fracture site as load sharing device, promoting early callus formation and resulting in better bone healing compared to traditional methods.[8]


  Subjects and Methods Top


In the present prospective study, 20 patients with Gustilo and Anderson Compound Grade 3A and 3B were selected, at a tertiary institute of Bhopal, from January 2020 to June 2021. Patients were randomly divided in a predefined manner from 1 to 20, with even numbers in Group 1 and odd numbers in Group 2 as they reported to institute. Group 1 was treated with antibiotic-impregnated cement-coated nail as shown in [Figure 1] and Group 2 patients were treated with external fixators as shown in [Figure 2]. This research was approved by the ethical committee of the institution and was done having consent of patients for their involvement in the study.
Figure 1: A 40-year-old male with Compound Grade 3B fracture of the tibial fracture. Preoperative wound and X-ray. Postoperative X-ray. Wound at follow-up

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Figure 2: A 45-year-old male with Compound Grade 3B fracture of shaft of tibia. Preoperative wound and X-ray. Postoperative wound and X-ray. Wound at follow-up

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Inclusion criteria

  • Adult patient
  • Hemodynamically stable patient
  • Compound Grade 3A and 3B fracture.


Exclusion criteria

  • Polytrauma/unstable patient
  • Pediatric patients with open physeal plate
  • Metaphyseal fractures
  • Bone loss exceeding 2 cm.


Preoperative evaluation

An initial detailed history of a patient was recorded including mode and nature of the trauma, consciousness level following trauma, and any emergency treatment taken. A complete clinical examination of the patient was done which included Glasgow coma scale, Revised Trauma Score, Mangled extremity severity score, and Ganga Hospital. Severity score. It was followed by emergency fluids and blood resuscitation as per ATLS protocol. Empirical systemic antibiotics 1 g cephazolin, analgesics, and tetanus toxoid were given at the time of admission. Simultaneously, wound management was done including thorough wash of wound done by copious normal saline according to the status of compounding removing gross contamination followed by sterile compression dressing and fracture was immobilized in Plastar of Paris splint. X-rays of affected leg obtained for preoperative evaluation and matching criteria for patient's inclusion in the study.

Procedure

We used vancomycin, meropenem, and cefuroxime in our study. Because most of the orthopedic trauma infections are caused by Gram-positive cocci (most common - S. aureus), these broad-spectrum antibiotics have excellent coverage on Gram-positive cocci in sensitive as well as resistant strains. In our study, we used Kuntscher nail (K-nail) because

  • Cloverleaf shape which holds cement in slot provides stability and rigidity
  • Slot of K-nail accommodates good amount of cement
  • Eye at either end makes removal easy.


The patient was operated under spinal/epidural anesthesia.

  1. Debridement of the compound wound: All nonviable muscles that are noncontractile or grossly contaminated were removed till bleeding edges. After the removal of dead, contaminated, and necrotic tissues, copious irrigation of the wound was done using adequate amount of normal saline.

    Following debridement, all the patients meeting the exclusion criteria were removed from the study. Eligible patients operated as per their group division.
  2. Stabilization

    Group 1: Nailing. We used K-nail of 8 mm diameter in all cases. Vancomycin 2 g, Meropenem 2 g, and cefuroxime 1.5 g were mixed with 20 g standard viscosity bone cement powder. A K-nail of optimal length was selected, and thereafter, we made around 11° Herzog bend over one end before coating of antibiotic cement. Regarding the determination of diameter of antibiotic-impregnated cement-coated nail, the reaming diameter was considered. We chose K-nail of 8 mm diameter and thereafter coated it with antibiotic-impregnated cement up to 1 mm less than maximum-sized reaming which ultimately provided snug fitting and improved stability of fixation.

    Group 2: External fixator: After debridement of compound wound, external fixator was applied.
  3. Soft tissue management: Primary closure was done wherever possible. In remaining cases, stay sutures were applied and secondary closure was done after 5–7 days. In case of severely compromised soft tissue and Gustilo Anderson type IIIB fractures, stay sutures were applied, and after 48 h, the patient was again taken to operation theater (OT) to check the status of compound wound and its readiness for soft tissue reconstruction including flap cover and skin grafting which was done after the repeat debridement of the wound.


Postoperative period

Postoperatively, the limb was kept elevated on a pillow. Immediate postoperatively, complications such as fat embolism, compartment syndrome, and neurovascular injury were looked for. The patient was again taken to the OT for second look of compound wound after 48 h. In cases in which primary closure was not possible, secondary procedures such as secondary closure, flap cover, or skin grafting was done. Parenteral antibiotics were given for 5 days and continued in the form of oral antibiotics till suture removal, which was done on 14th day after the soft tissue reconstruction in most of cases. Radiograph of the leg was taken to assess the fracture alignment, reduction, and nail/pin placement. Knee range of motion exercises started on 2nd postoperative day. After the suture removal, nonweight-bearing ambulation started with the help of walker. Postoperative inflammatory markers such as total leukocyte count, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) were evaluated.

Patients were followed up periodically in the outpatient department visits at 2nd, 4th, and 6th week till the definitive procedure was done (antibiotic-coated nail/external fixator exchanged with interlocking nail for better rotational stability. Cement-coated nails are also prone to decoupling and jamming during extraction, if removed after long duration; hence, we replaced these nails with interlocking nails after wound healing).

Assessment criteria: We determined the infection control by

  1. Clinical condition of wound (no active discharge, no pin tract infection, no signs of inflammation, healthy suture line, and no wound dehiscence)
  2. Evaluation of laboratory tests (complete blood count, ESR, and CRP).



  Results Top


There were a total of 20 patients were enrolled in the study. Out of 20 patients, 10 patients were included in each group.[Table 1].
Table 1: Comparison of outcomes between both study groups

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Mean age of Group 1 patients was 37.2 while Group 2 was 38.9. In Group 1, there were 8 males and 2 females, and in Group 2, there were 7 males and 3 females. There were 7 cases of Compound Grade 3A and 3 cases of Compound Grade 3B in Group 1, while 8 cases of Grade 3A and 2 cases of Grade 3B were involved in Group 2.

After a mean follow-up of 6 weeks, the infection rate was 10% (1 out of 10) in Group 1 and 50% (5 out of 10) in Group 2.

The average time taken for soft tissue reconstruction in Group 1 was 32 min ± 6.23 and Group 2 was 51 min ± 5.83.

In Group 1, only one patient had infection at 2 weeks which was superficial and responded well to oral antibiotics and dressing. In Group 2, five patients had infection at first follow-up, out of which three patients had superficial infection which responded to oral antibiotics and daily dressing with pin tract care and two patients required soft tissue debridement and put on antibiotics and dressing till healing. At final follow-up of 6 weeks, these infections showed improvement but not resolved completely, hence required longer interval between primary and definitive fixation.

Primary and secondary closure was done in 7 cases of Group 1 and 3 cases required soft tissue reconstruction including fasciocutaneous flap and skin grafting. In Group 2, primary and secondary closure was done in 8 cases while 2 patients required soft tissue reconstruction. We had difficulty in reconstruction in Group 2 patients because of the outside situated external fixator.

Duration between primary and definitive surgery in Group 1 was 5.7 weeks ± 0.45 and in Group 2 was 6.3 ± 1.004 weeks.


  Discussion Top


In the present study, 20 cases of compound fractures of shaft of tibia were managed with antibiotic-impregnated cement-coated intramedullary nail and external fixator. All fractures were due to high-velocity road traffic accident. This was comparable to earlier studies.[9] These fractures have significant morbidity and high chances of contamination. Surgical intervention including debridement and irrigation of wound decreases contamination and infection. Early stabilization of compound fractures provides length, alignment, and rotational restoration, which prevents further damage from mobile fragments.

Early fixation can be done by external fixator, intramedullary nails, and plates. However, many studies showed that plating has higher failure rate and contamination in compound tibial shaft fractures. Hence, we fixed these fractures with antibiotic-impregnated cement-coated nail and external fixators only. However, many studies showed that external fixator alone has multiple complications such as high failure rate, high infection rate and difficulty in soft tissue reconstruction.[10]

Considering these literature studies, we carried out comparative study between external fixator and antibiotic-impregnated cement-coated nail in primary fixation of compound fractures.

Various researchers have documented the importance of local elution of antibiotic as a game-changer for achieving union in compound fractures than traditional external fixators [Table 2].
Table 2: Comparison of infection rate between various studies

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Department of Orthopaedics, MIMER Medical College, Pune, conducted a study in which they compared external fixator with primary intramedullary nailing and placement of antibiotic bone cement beads and concluded that the infection rate after nailing was 6.67% compared to external fixator in which the infection rate was 40%. In our study, results were better and comparable to this study as the infection rate with nailing was 10% and with external fixator was 50%.[11]

Raschke et al. quoted that an intramedullary nail with antibiotic impregnation is a very useful tool in the treatment of open tibial fractures.[12]

Bhatia et al. conducted a study and concluded that antibiotic cement-impregnated nailing is a very effective treatment method of compound tibial fractures and nonunion, providing technical simplicity, economic benefit, and a single-stage procedure. They controlled infection in 95% of the patients.[5]

Desouuza et al. also documented the role of antibiotic-coated nail in compound fracture of shaft of tibia. There was no infection in 95% of the patients.[13]


  Conclusion Top


Primary antibiotic impregnated cement coated nail prevents compound wounds to get infected and provides good stability to promote union.

Among its advantages over external fixators, it prevents thriving of infection at fracture site, provides better stability, has increased compliance due to minimal psychosocial burden, easy availability, technical simplicity, versatility and cost efficiency.

By adopting to this method the gruesome complications of compound fracture infections can be dealt with easy and cost effective way even at minimal setup.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Gustilo RB, Anderson JT. Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones: Retrospective and prospective analyses. J Bone Joint Surg Am 1976;58:453-8.  Back to cited text no. 1
    
2.
Michail B. External fixation as a primary and definitive treatment for tibial diaphyseal fractures. STLR 2009;4:81-7.  Back to cited text no. 2
    
3.
Kazmers NH, Fragomen AT, Robert Rozbruch S. Prevention of pin site infection in external fixation: A review of the literature. Strategies Trauma Limb Reconstr 2016;11:75-85.  Back to cited text no. 3
    
4.
Clifford RP, Lyons TJ, Webb JK. Complications of external fixation of open fractures of the tibia. Injury 1987;18:174-6.  Back to cited text no. 4
    
5.
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. 5
    
6.
Baleani M, Persson C, Zolezzi C, Andollina A, Borrelli AM, Tigani D. Biological and biomechanical effects of vancomycin and meropenem in acrylic bone cement. J Arthroplasty 2008;23:1232-8.  Back to cited text no. 6
    
7.
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. 7
    
8.
Riel RU, Gladden PB. A simple method for fashioning an antibiotic cement coated interlocking intramedullary nail. AM J Orthop 2010;39:18-21.  Back to cited text no. 8
    
9.
Bai-Ping X, Ming L, Wei-Min M, Rong-Ming X, Long Z, Jing-Wei Z. Therapeutic strategies of grade-III open fractures of tibia and fibula. China J Orthop Traumatol 2008;21:289-90.  Back to cited text no. 9
    
10.
Almazedi B. Intramedullary nailing versus external fixation for the treatment of Grade III open tibial fractures. J Bone Joint Surg Br 2011;93:310.  Back to cited text no. 10
    
11.
Borkar S, Maheshgauri D, Bhoir V. Comparison of early management of compound grade 2 and 3a (gustilo-anderson) fractures of tibia shaft using primary intramedullary nailing and placement of antibiotic bone-cement beads, with that of external fixator application. Natl J Med Res [Internet]. 2017 Jun. 30 [cited 2022 Jul. 18];7(02):79-82.  Back to cited text no. 11
    
12.
Raschke MJ,Rosslenbroich SB, Thomas F. Fuchs antibiotic coated nails. Arch Orthop Trauma Surg. 2011 Oct; 131(10): 1419–1425.  Back to cited text no. 12
    
13.
Desouuza C, Nair V, Chaudhary A, Hurkat H, George S. Role of antibiotic cement-coated nailing in infected nonunion of tibia. Trauma Int 2018;4:18-21.  Back to cited text no. 13
    


    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2]



 

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