Short term results with the use of PLA antibiotic coated nail in open tibia fractures: A prospective study

Abstract

Background

Antibiotic impregnated cement coated nails have been described in literature with promising success rates. However, they need removal at a later stage. This study focuses on use of a PLA-precoated antibiotic nail that stops eluting antibiotic after a while and can be retained later as it behaves as a standard interlocking nail in the long run.

Purpose

To study if PLA (polylactic acid) -antibiotic coated nails reduces infection and non-union rates and improve the functional outcome in open tibial shaft fracture cases.

Materials and methods

In this prospective cohort study, we included 54 patients with open tibia shaft fractures treated with wound debridement and internal fixation using a reamed PLA (polylactic acid)-antibiotic coated nail (CE-certified, OSSIPRO, MatrixTM).

Results

Forty patients with a Grade 2 and ten with grade 3A open tibial fracture, according to the Gustilo-Anderson classification, completed a minimum of six months of follow-up and were included in the analysis. At the final follow-up, four patients (all with grade 3A fracture) had an active infection, 10 (four of grade 2 and six of grade 3A) had non-union, the mean physical component score (SF-36 score) was 55.2 ± 20.10 (grade 2; 58.95 ± 9.99, grade 3A; 40.19 ± 16.37, P value 0.002), and the mean mental component score (SF-36 score) was 54.96 ± 23.5 (grade 2; 57.96 ± 16.63, grade 3A; 42.94 ± 23.75, P value 0.04). Furthermore, Multivariate analysis showed age and grade of fracture to be independently related to the development of infection and non-union.

Conclusion

Although the use PLA-antibiotic coated nail looks promising, short-term results have revealed no additional benefit in terms of reduced infection rates, improved union rates or functional outcomes. Large multicentric randomized controlled trials and a long term follow up are advised to further explore the role of PLA coated antibiotic nails in open tibial fractures.

1. Introduction

Management of an open tibia fracture is an orthopaedic challenge, as the combat is at two fronts simultaneously i.e. management of soft tissues and bony injury. It is a known fact that despite the usage systemic antibiotics, open fractures report higher infection rates as compared to closed fractures. The primary reason for higher infection rates in open fractures as compared to closed is the presence of biofilm which act as an impenetrable barrier and impedes the delivery of systemic antibiotics at the tissue implant interface.1, 2, 3 To overcome this problem it was postulated that improved infection prophylaxis can be achieved by systems that have the ability to deliver a higher concentration of antibiotics directly at the tissue implant surface. One such delivery system includes gentamycin polymethylmethacrylate (PMMA) bead chains and gentamycin coated collagen sponges (Sulmycin; Septocoll™).^4,5 However, an inherent lacune in these delivery systems is the lack of continuous and controlled release of antibiotic at the tissue implant surface thereby resulting in incomplete eradication of infection. Moreover, these non-biodegradable beads and sponges require removal after 4–6 weeks thereby mandating a second surgery. To overcome these limitations, polylactic acid (PLA) coated gentamycin devices have been put forth which not only have sustained release kinematics but are also biodegradable. One such implant, an antibiotic (gentamicin) impregnated nail (CE-certified, UTN PROtect, Synthes™) was launched in 2005, which delivered antibiotic at implant-bone interface, thus, potentially, circumventing the problems of biofilm formation and erratic release of antibiotic.

Recently, a new PLA-antibiotic coated nail had been launched in India (CE-certified, OSSIPRO, Matrix™). This was the first and only PLA-antibiotic coated nail manufactured domestically. Authors of the present study have evaluated the role of PLA coated antibiotic nail by analyzing the infection rates, radiological union and functional outcome, in open tibial shaft fracture cases managed with PLA-antibiotic coated nail.

2. Material and methods

The study was conducted in a tertiary care trauma unit between June 2015to June 2016 after being approved by Institutional Ethics Committee. The study was registered with a public database. This was a descriptive cohort study conducted in a prospective manner. Written informed consent was obtained from all the patients

Adults aged 18 years or more with open tibial shaft fractures (grade 2 and 3a), amenable to intramedullary nailing and with intact distal neurovascular status in affected limb were included in the study. Patients with closed tibial shaft fractures, open tibial shaft fractures not amenable to intramedullary nailing, open grade 1,3b and 3c fractures, pregnant or breast-feeding females, patients with known allergy to aminoglycosides and patients with chronic renal failure were excluded from the study.

Upon presenting in the emergency room (ER), patients underwent a primary survey and were adequately resuscitated, as needed. An intravenous access was gained and first dose of empirical antibiotics given. Patients' distal neurovascular status was checked and documented. Mode of injury was noted along with other demographic data. Time from injury to first antibiotic dose was recorded. Patients were also given tetanus prophylaxis as per the CDC guidelines.¹⁸ A photograph of the wound was taken for medical records. Gross, visible easily accessible contaminants were removed prior to any irrigation and dressing. Emergency irrigation was given with adequate quantity of sterile saline solution, without use of any additives. Dressing of the wound was done and adequate splintage given. Patients’ distal neurovascular status was re-checked and documented again. Once haemodynamically stable, patients were sent for x-rays. Patients were counseled about the need for surgery and prepared for the same.

Time from injury to surgery was recorded. All patients underwent a thorough debridement of wound and wash with 6–9 L of normal saline, followed by open reduction and internal fixation of fracture with PLA-antibiotic coated nail (CE-certified, OSSIPRO, Matrix™). Reamed nailing was performed in all the cases. Patients’ distal neurovascular status was checked post-operatively and documented. Skin-to-skin operative time was also recorded.

The intramedullary nail, OSSIPRO, consists of gentamycin sulphate in a matrix of polylactic acid. An average coating of 10 μm consists of a total of 50 mg of drug. Initial high concentrations of 200 μg per millilitres is released for first 3–4 days and then there is sustained release for 4–6 weeks.

Patients with open grade 2 fractures received i/v cefazolin while an aminoglycoside, i.e. gentamicin, was given along with cefazolin for open grade 3a fractures. Upon evidence of organic contamination, metrogyl was added. All antibiotics were given in weight-adjusted therapeutic dosages. Antibiotics were started from the time of presentation to the hospital to 72 h post-surgery.

Patients were mobilized on post-op day 1. Knee bending, static quadriceps exercises, ankle foot pumps and toe-touch walking were started on post-op day 1. If the post-op dressing was clean and patient's physiotherapy performance was found to be satisfactory, patients were given the option of taking discharge and following up for suture removal on post-op day 14.

Patients were regularly followed up at 6 weeks, 3 months and 6 months. Patients were examined to look for any clinical signs of infection i.e. local rise of temperature, tenderness, swelling, reddish discoloration or discharging sinus. If there was a suspicion of infection, then laboratory investigations (ESR, CRP, TLC, DLC, culture/sensitivity) were sent.

Radiographs were taken at each follow-up to assess union at fracture site. Radiological union was defined as bridging of 3/4 cortices on orthogonal views of radiographs. At 6 months of follow-up, patients’ SF-36 scores¹⁵ were calculated. SF-36 scores were further divided into physical component score (PCS) and mental component score (MCS).

3. Statistical analysis

Discrete categorical data was presented as n (%). Continuous data was given as mean ± SD and range or median and interquartile range, as appropriate. Normality of quantitative data was checked by measures of Kolmogorov Smirnov tests of normality. For skewed data, comparisons for two groups (grade 2 vs 3a) were made by Mann-Whitney test. For normally distributed data, student t-test was applied to compare the two groups. For categorical data, comparisons were made for two groups by using Pearson Chi-square test or Fisher's exact test, as appropriate. Multivariate analysis was performed using logistic regression analysis or multivariate regression analysis, as appropriate. All statistical tests were two-sided and performed at a significance level of α = 0.05. Analysis was conducted using IBM SPSS STATISTICS (version 22.0).¹⁶

4. Results

A total of 54 patients were included in the study based on inclusion/exclusion criteria. Out of these, 4 patients were lost to follow up. So, a total of 50 patients completed the minimum follow up of 6 months. Out of these 50 patients, 40 were classified to be suffering from open grade 2 tibia fracture while 10 were found to be suffering from open grade 3a tibia fracture¹⁷

4.1. Age distribution

The mean age of patients enrolled in the study was 34.42 ± 12.55 years. The mean age of patients suffering from open grade 2 tibia fracture was 32.90 ± 11.88 years. The mean age of patients suffering from open grade 3a tibia fracture was 40.50 ± 13.9 years. Both the groups were comparable in terms of age (p value 0.087).

4.2. Gender distribution

A total of 46 male patients and 4 female patients were included in the study. 37 males and 3 females suffered from open grade 2 tibia fracture, while 9 males and 1 female suffered from open grade 3a tibia fracture.

4.3. Mode of injury

Mode of injury was roadside accident in 47 patients, fall from stairs in 2 patients and injury sustained while playing football in one patient.

4.4. Associated injuries

Associated injuries included: clavicle fracture (ipsilateral side) in 4 cases (managed conservatively), distal radius fracture (ipsilateral side) in 2 cases (one managed conservatively and one underwent open reduction and internal fixation with volar plating), shaft femur fracture (ipsilateral side) in one case (managed by closed intramedullary nailing), medial malleolus fracture (bilateral) in one case (managed bilaterally by open reduction and internal fixation with two 4 mm partially threaded cannulated screws and open grade 3b both bone leg fracture (contralateral side) (managed by debridement, external fixator application and flap).

4.5. Time duration from injury to first antibiotic dose

The mean of total time duration taken, from injury to administration of the first antibiotic dose in patients enrolled in the study was 2.26 ± 0.93 h. The mean injury to first antibiotic dose time in patients suffering from open grade 2 tibia fracture was 2.21 ± 0.94 h. The mean injury to first antibiotic dose time in patients suffering from open grade 3a tibia fracture was 2.45 ± 0.90 h. Both the groups were comparable in terms of injury to first antibiotic dose time (p value 0.419).

4.6. Injury to surgery time

The mean injury to surgery time in patients enrolled in the study was 49.68 ± 8.94 h. The mean injury to surgery time in patients suffering from open grade 2 tibia fracture was 49.50 ± 8.64 h. The mean injury to surgery time in patients suffering from open grade 3a tibia fracture was 50.40 ± 10.53 h. Both the groups were comparable in terms of injury to surgery time (p value 0.779).

4.7. Operative time

The mean operative time in patients enrolled in the study was 129.80 ± 12.82 min. The mean operative time in patients suffering from open grade 2 tibia fracture was 129.50 ± 12.85 min. The mean operative time in patients suffering from open grade 3a tibia fracture was 131.00 ± 13.29 min. Both the groups were comparable in terms of operative time (p value 0.744).

4.8. Complications

4.8.1. Infection

A total of 4 patients suffered from infection in the study. All these 4 patients suffered from open grade 3a tibia fracture (4/10, 40%). None of the patients suffering from open grade 2 tibia fracture got infected (0/40, 0%). Comparison between the two groups in terms of infection rate showed statistically significant difference (p value 0.001).

All four infected cases underwent debridement and irrigation of the wound, followed by administration of i/v antibiotics according to culture sensitivity. Infection settled in one case with single debridement and administration of i/v antibiotics. Rest of the three cases underwent nail removal along with re-debridement and external fixator application (Table 1).

Table 1.

Details of infected cases.

Serial No.	Clinical and laboratory indicators of infection	Intervention
1.	•Redness, swelling, local rise of temperature, tenderness + nt •ESR: 38 (mm 1st hour) •CRP: 76.1 mg/L •TLC: 12500/microL •DLC: 79/20/1/0	•Debridement done •No recurrence of infection
2.	•Purulent discharge from wound + nt (C/S: Klebsiella) •ESR: 45 (mm 1st hour) •CRP: 95.6 mg/L •TLC: 12200/microL •DLC: 83/16/1/0	•Debridement done •Recurrence of infection •Nail removal + Re-debridement + External Fixator application done
3.	•Purulent discharge from wound + nt (C/S: MRSA) •ESR: 32 (mm 1st hour) •CRP: 83.7 mg/L •TLC: 11900/microL •DLC: 80/18/1/1	•Debridement done •Recurrence of infection •Nail removal + Re-debridement + External Fixator application done
4.	•Purulent discharge from wound + nt (C/S: MRSA) •ESR: 43 (mm 1st hour) •CRP: 101.2 mg/L •TLC: 12900/microL •DLC: 83/15/2/0	•Debridement done •Recurrence of infection •Nail removal + Re-debridement + External Fixator application done

5. Additional procedures

Six patients underwent an additional procedure in the form of dynamization at 6 weeks of follow up.

6. Union/non-union

At 6 months follow up, 40 patients showed radiological union (i.e. bridging of at least 3 out of 4 cortices on orthogonal views). Out of these, 36 patients belonged to the open grade 2 tibia fracture group whereas 4 patients belonged to open grade 3a tibia fracture group. Thus, the overall union rate of the study at 6 months was 80%, with union rates being 90% and 40% in open grade 2 and grade 3a groups respectively. Comparison between the two groups in terms of union rate showed statistically significant difference (p value 0.002).

A total of 10/50 patients couldn't achieve union by 6 months. 4 of these patients underwent ‘autologous bone-grafting from ipsilateral iliac crest’ while 2 patients underwent ‘exchange nailing and autologous bone-grafting from ipsilateral iliac crest’. 4 patients, who got infected and underwent surgical interventions for the same, had not achieved union at the fracture site by 6 months. One these patients underwent ‘autologous bone-grafting from ipsilateral iliac crest’ at a later stage while the other three underwent nailing and bone grafting at a later stage.

6.1. SF-36 score (PCS & MCS)

SF-36 score is divided into two components: PCS (physical component score) and MCS (mental component score). At 6 months follow up, the mean PCS of patients enrolled in the study was 55.2 ± 20.10. The mean PCS of patients suffering from open grade 2 tibia fracture was 58.95 ± 9.99. The mean PCS of patients suffering from open grade 3a tibia fracture was 40.19 ± 16.37. Comparison between the two groups in terms of PCS showed statistically significant difference (p value 0.002).

At 6 months follow up, the mean MCS of patients enrolled in the study was 54.96 ± 23.5. The mean MCS of patients suffering from open grade 2 tibia fracture was 57.96 ± 16.63. The mean MCS of patients suffering from open grade 3a tibia fracture was 42.94 ± 23.75. Comparison between the two groups in terms of MCS showed statistically significant difference (p value 0.04).

6.2. Subgoup analysis

Since all infected cases belonged to open grade 3a group, this group underwent subgroup analysis. Infected and non-infected cases of open grade 3a group were compared in terms of injury to first antibiotic dose time, injury to surgery time and operative time. This comparison showed statistically significant difference in terms of injury to surgery time but statistically non-significant difference in terms of injury to first antibiotic dose time and operative time.

7. Injury to first antibiotic dose time (grade 3a)

The mean injury to first antibiotic dose time in open grade 3a patients was 2.45 ± 0.90 h. The mean injury to first antibiotic dose time in patients who got infected (open grade 3a) was 2.50 ± 1.22 h. The mean injury to first antibiotic dose time in patients who did not suffer from infection (open grade 3a) was 2.42 ± 0.74 h. Both the groups were comparable in terms of injury to first antibiotic dose time (p value 0.914).

8. Injury to surgery time (grade 3a)

The mean injury to surgery time in open grade 3a patients was 50.40 ± 10.53 h. The mean injury to surgery time in patients who got infected (open grade 3a) was 58.00 ± 13.44 h. The mean injury to surgery time in patients who did not suffer from infection (open grade 3a) was 45.33 ± 3.77 h. Comparison between the two subgroups in terms of injury to surgery time showed statistically significant difference (p value 0.013).

9. Operative time (grade 3a)

The mean operative time in open grade 3a patients was 129.80 ± 12.82 min. The mean operative time in patients who got infected (open grade 3a) was 123.75 ± 11.09 min. The mean operative time in patients who did not suffer from infection (open grade 3a) was 135.83 ± 13.20 min. Both the groups were comparable in terms of operative time (p value 0.197).

9.1. Multivariate analysis

Multivariate analysis was performed to analyze the effect of multiple independent variables on the dependent variables i.e. outcome variables (infection, union, PCS and MCS).

To analyze union and infection, logistic regression analysis was used whereas to analyze PCS and MCS (SF-36), multivariate regression analysis was used.

10. Infection

Infection was found to have statistically significant dependence on grade of injury (p value 0.0001) and age (p value 0.03).

Infection wasn't found to be statistically dependent on rest of the variables (injury to first antibiotic dose time; p value 0.59, injury to surgery time; p value 0.05 and operative time; p value 0.32).

11. Union at 6 months

Union at 6 months was found to be negatively correlated with grade of injury (correlation coefficient: 2.5), along with a statistically significant dependence on grade of injury (p value 0.006).

Union at 6 months was also found to be negatively correlated with age of the patient (correlation coefficient: 0.07), along with a statistically significant dependence on age (p value 0.04).

Union at 6 months wasn't found to be statistically dependent on rest of the variables (injury to first antibiotic dose time; p value 0.69, injury to surgery time; p value 0.63 and operative time; p value 0.84).

Since none of the cases that got infected could achieve union at 6 months, hence infection was not included as an independent variable in the analysis.

12. Physical component score (SF-36) at 6 months

PCS (SF-36) at 6 months was found to be positively correlated with union at 6 months (correlation coefficient: 21.6), along with a statistically significant dependence on union (p value 0.0001).

PCS (SF-36) at 6 months was found to be negatively correlated with grade of injury (correlation coefficient: 6.04), along with a statistically significant dependence on grade of injury (p value 0.04).

PCS (SF-36) at 6 months was found to be negatively correlated with age of the patient (correlation coefficient: 0.26), along with a statistically significant dependence on age (p value 0.006).

PCS (SF-36) at 6 months wasn't found to be statistically dependent on rest of the variables (injury to first antibiotic dose time; p value 0.16, injury to surgery time; p value 0.21, operative time; p value 0.46 and infection; p value 0.20).

13. Mental component score (SF-36) at 6 months

MCS (SF-36) at 6 months was found to be positively correlated with union at 6 months (correlation coefficient: 22.72), along with a statistically significant dependence on union (p value 0.0001).

MCS (SF-36) at 6 months was found to be negatively correlated with age of the patient (correlation coefficient: 0.46), along with a statistically significant dependence on age (p value 0.02).

MCS (SF-36) at 6 months wasn't found to be statistically dependent on rest of the variables, (injury to first antibiotic dose time; p value 0.16, injury to surgery time; p value 0.18, operative time; p value 0.05, grade of injury; p value 0.94 and infection; p value 0.99).

14. Post hoc power analysis

The power of the study as calculated using a web based calculator (clincalc.com) on the basis of infection rates in open grade 2 and grade 3a fractures was 91.4% and on the basis of radiological union rates in open grade 2 and grade 3a fractures was 91.5%

15. Discussion

In the present study, grade 2 and grade 3a groups were comparable in terms of age of the patients, injury to first antibiotic dose time, injury to surgery time and operative time. Hence, any significant difference between the two groups in terms of any outcome variable was a result of difference in grade of open fracture and hence, the severity of injury.

Out of a total of 50 patients, 4 got infected, thus giving us an infection rate of 8% in our study. Since none of the open grade 2 cases got infected and 4 out of 10 open grade 3a cases got infected, the infection rates of open grade 2 and grade 3a tibia fractures, managed with PLA-antibiotic coated nail, in our study were 0% and 40% respectively. Comparison between the two groups in terms of infection rates showed statistically significant difference, thus suggesting a lower incidence of infection in grade 2 cases as compared to grade 3a. Hence, the more severe the injury, higher the rates of infection. This observation is consistent with the findings in literature, which report an infection rate of 5–33% in open fractures depending on the severity of injury.^6,7

Prophylactic intravenous antibiotics should be administered as soon as practical, ideally within 3 h of injury. Prophylactic antibiotics reduce the incidence of early infections in open limb fractures. Patzakis et al.⁷ showed that empiric cephalosporin administration lowered the infection rate in the treatment of open fractures. If administered within 3 h, this can be up to 6 fold. The mean injury to first antibiotic dose time in our study was 2.26 ± 0.93 h, i.e. less than 3 h. Since both grade 2 and grade 3a cases were comparable for injury to first antibiotic dose time, the difference in infection rates between the two groups cannot be related to the same. Further subgroup analysis of grade 3a infected and non-infected cases also showed comparable injury to first antibiotic dose time. Hence, injury to first antibiotic dose time was not an independent risk factor for infection in our study. This finding can be explained by the fact that the mean injury to antibiotic dose time in all our groups and subgroups is less than 3 h.

We followed the standard practice of providing gram positive coverage (i.e. cephalosporin) for all type II fractures and broader antimicrobial coverage (i.e. cephalosporin + aminoglycoside) for type III fractures. Prolonged antibiotic prophylaxis increases the risk of hospital-acquired infection and may precipitate multidrug-resistant organisms becoming the pathogens of the trauma patient. There is no evidence supporting the use of antibiotic prophylaxis beyond 72 h. We complied with this evidence based teaching and administered antibiotics for a maximum period of 72 h post-surgery.

The literature is divided on the topic of injury to surgery (debridement) time being an independent risk factor for infection in open fracture cases. Historical literature has suggested emergent debridement to minimise the risk of significant complications related to infection.8, 9, 10 The golden period of doing debridement with the first 6 h was related to Friedrich's animal study data from late 19th century. More recent literature has widely suggested that timing from injury to operative debridement is not a significant independent predictor of infection risk in open fractures. However, there is a study which suggests that time from injury to debridement plays a role in determining infection in severe injuries (i.e. grade 3 open fractures). The less serious fractures (grade 1 and 2) are not affected by delay in injury to surgery time as much as the more serious fractures (grade 3). They recommended that the more severe fractures be operated as soon as possible. These observations are in unison with our study as well. In our study, the subgroup analysis of grade 3a cases revealed a statistically significant difference between the infected and non-infected cases in terms of injury to surgery time.

The union rates in the current study were 80%, with cases of open grade 2 and grade 3a tibia fractures having union rates of 90% and 40% respectively. Comparison between the two groups in terms of union rates showed statistically significant difference. Thus, the more severe the injury, lower the rates of union.

Patients’ functional outcome was assessed at 6 months of follow up using SF-36 score. SF-36 score can be subdivided into PCS and MCS. Comparison between the two groups in terms of PCS and MCS at 6 months of follow up showed statistically significant difference, thus suggesting a better physical and mental aspect of functional outcome in grade 2 cases as compared to grade 3a. Thus, the more severe the injury, poorer the functional outcome.

The preliminary results of PLA -antibiotic coated tibia nail in open tibial fractures and revision cases were first reported by Fuchs et al.¹¹ in 2011. Out of the 19 patients who completed the 6 month follow up, none of the cases suffered from implant related infection. The union rate achieved at 6 months was 58%. The mean SF-36 physical score was 42.55 (range 19.35–56.68) and the mean SF-36 mental score was 50.45 (range 27.48–64.98). Metsemakers et al. ¹² reported another study showing the results of PLA-antibiotic coated tibia nail in complex open tibia fractures and revision cases. Out of the 16 patients enrolled in the study, none of the cases suffered from deep infection. The union rate achieved was 75%. The results of our study vary from these reported results. We observed an infection rate of 8% and union rate of 80%, with the mean SF-36 physical score being 55.2 ± 20.10 and the mean SF-36 mental score being 54.96 ± 23.5.

Multivariate analysis was performed to analyze the effect of multiple independent variables on the dependent variables i.e. outcome variables (infection, union, PCS and MCS {SF-36}).

Infection was found to have statistically significant dependence on grade of injury and age. Union at 6 months was found to have statistically significant dependence on grade of injury and age. PCS (SF-36 score) at 6 months was found to have statistically significant dependence on union at 6 months, grade of injury and age. MCS (SF-36 score) at 6 months was found to have statistically significant dependence on union at 6 months, age and operative time.

The findings of multivariate analysis further strengthened the claim that the most important variable affecting the outcome in open fractures is grade of injury. Irrespective of the grade of injury, age was found to affect all the outcome variables (infection, union and functional outcome). Role of age as an independent factor in determining the final outcome can be explained as young patients have better healing potential, lesser co-morbidities, superior physical capacity and higher motivational levels.

The use of PLA-antibiotic coated nail has shown promising results in a couple of studies in literature. ^13,14 But in our study, the infection rate (8%, ranging from 0 to 40% from grade 2 to grade 3a) with the use of PLA-antibiotic coated nail is similar to that reported with debridement and conventional nailing (5–33% ranging from grade 1 to grade 3).

16. Strengths of the study

There are just two studies in literature showing results with the use of PLA-antibiotic coated tibia nail in complex tibia fractures, revision cases and open fractures. The sample size of these reported studies is 21 and 16 patients respectively. The current study included 50 patients of open tibia fractures alone with a minimum follow up of 6 months. A higher sample size of the study and stringent inclusion criteria are strengths of our study. The nail used in this study is the first and only domestically manufactured PLA-antibiotic coated tibia nail, hence cheaper as compared to the already available imported PLA-antibiotic coated nail in the market. In a developing country, affordability of the implant is a critical issue.

17. Limitation of the study

A 6 month follow up is a short term follow up. Longer follow up is required to assess the long term outcome with the use of such an implant.

18. Conclusion

Although the use PLA-antibiotic coated nail looks promising, short-term results have revealed no additional benefit in terms of reduced infection rates, improved union rates or functional outcomes. Large multicentric randomized controlled trials and a long term follow up are advised to further explore the role of PLA coated antibiotic nails in open tibial fractures.

Funding/sponsorship

This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors”.

Informed consent (patient/guardian)

Written informed consent was taken from each participant of the study.

Institutional ethical committee

Approval was obtained for this prospective observational study.

Authors contribution

Anubhav Malhotra-conceptualization and resources and writing original draft; Anant Krishna- Writing-review and editing; Sudhir Kumar Garg- Supervision; Sandeep Gupta- Project administration; Rohit Jindal- Data Curation; Gunjar Jain-Formal analysis

Declaration of competing interest

None