Background: The first objective of this
retrospective study was to assess infection control rates in patients with
chronic post-traumatic osteomyelitis (CPTO) of the femur or tibia treated
with antibiotic cement-coated nails. The second objective was to compare the
efficacy of custom-made nails versus commercially available
antibiotic-coated nails in terms of infection control and need for
reoperation. Methods: We reviewed a consecutive series of CPTO
patients treated with antibiotic-coated nails who had a minimum follow-up of
24 months. We recorded the characteristics of the initial injury, the type
of nail used, cement–nail debonding, infecting microorganisms, operating
time, infection control, need for reoperation, and failure rate. We
performed a comparative analysis between nails manufactured in the operating
room (i.e., custom-made) and those commercially available. Results:
Thirty patients were included. The affected bones were the femur
(n=15) and the tibia (n=15). Twenty-one of the 30 initial
injuries were open fractures. Staphylococcus aureus was the most frequently
isolated microorganism (50 %). Sixteen patients were treated with
custom-made nails and 14 with commercially available antibiotic-coated
nails. At the time of extraction, four out of five custom-made antibiotic-coated
nails experienced cement–bone debonding. Commercial nails were associated
with shorter operating times (p<0.0001). The overall infection
control rate was 96.66 %. Eight (26.66 %) patients needed reoperation.
There was one failure (3.33 %) in the group treated with custom-made
antibiotic-coated nails. We did not find significant differences between
nail types in terms of reoperation, infection control, and failure rate.
Conclusions: The use of antibiotic cement-coated nails proved
useful in CPTO treatment. Commercially available nails had significantly
shorter operating times and did not present cement–bone debonding during
removal. Our results seem to indicate that both nail types are similar in
terms of infection control and reoperation rates.
Introduction
Post-traumatic osteomyelitis (PTO) is a challenging condition both for
surgeons and patients (Hake et al., 2015). It can occur after the surgical
treatment of closed or open fractures, though it is more frequent in the
latter. Its reported prevalence ranges from 0.7 % to 33 % (Patzakis and Zalavras,
2005; Patzakis et al., 1986; Barger et al., 2017; Chadayammuri et al., 2017; Beals and Bryant,
2005).
At present, patient management practices include aggressive surgical
debridement, bone stabilization, adequate soft tissue coverage, and the
administration of specific antimicrobials depending on the infecting
microorganism (Patzakis and Zalavras, 2005; Beals and Bryant, 2005; Tetsworth and
Cierny, 1999; Cierny et al., 2003). Another important aspect to take into
consideration is dead space management generated by the resection of
devitalized tissue, bone sequestrum, and/or the removal of previous
osteosynthesis (Hake et al., 2015; Tetsworth and Cierny, 1999; Cierny et al.,
2003). Here host immune response and systemic antibiotic therapy tend to be
weak (Cierny el al., 2003; Koury et al., 2017; Gosselin et al., 2004; Wasko
and Borens, 2013). The use of antibiotic-loaded polymethylmethacrylate
(PMMA) beads described by Klemm (1979) has proven effective for the local
administration of antimicrobials; however, when the medullary cavity is
affected by the infection – due to dissemination or colonization of an
intramedullary nail – placing and removing the beads from this cavity is
usually difficult (Klemm et al., 1998; Barger et al., 2017). In these cases,
an antibiotic-coated intramedullary metal core can be used (Barger et
al., 2017; Koury et al., 2017; Paley and Herzenberg, 2002; Bhadra and
Roberts, 2009). Since they were first described, these devices have
demonstrated efficacy in the treatment of long bone osteomyelitis with
infection control rates of up to 80 %–100 % (Klemm et al., 1998; Bhadra and
Roberts, 2009; Conway et al., 2014; Wasko and Kaminski, 2015; Makhdom et al.,
2020).
Kanakaris et al. (2014) reported a 96 % success rate in a series of 24 PTO
patients at 21 months of follow-up with the use of rods as a metal core.
Among other advantages, these intramedullary devices offer high local
antibiotic concentration and may even provide mechanical support –
depending on the type of metal core used in the manufacturing process
(Barger et al., 2017; Kim et al., 2014).
While many studies in the literature have assessed the efficacy of
antibiotic cement-coated nails (Wasko and Borens, 2013; Conway et al., 2014;
Wasko and Kaminski, 2015; Kanakaris et al., 2014; Kim et al., 2014), few
have made a comparative assessment of the results obtained with custom-made
nails made in the operating room versus commercially available nails.
The main objective of this retrospective study was to assess the
effectiveness of antibiotic cement-coated nails to control infections in a
series of patients with chronic post-traumatic osteomyelitis (CPTO) of the
femur or tibia. Our second objective was to compare infection control and
reoperation and failure rates of custom-made versus commercially available
antibiotic-coated nails.
Materials and methods
We retrospectively reviewed our department's database to identify
consecutive patients treated with an antibiotic cement-coated nail for
post-traumatic osteomyelitis between January 2010 and December 2017. The
diagnosis of osteomyelitis was suspected when some of the following
clinical, laboratory or imaging parameters were found: swelling, redness,
pain, fever (>38∘C), or active fistula or wound drainage
with bone exposure or osteosynthesis; white blood cell count, erythrocyte
sedimentation rate, and C-reactive protein; or cloacae, sequestra,
involucrum, or periostitis on radiographs and/or MRI. Diagnosis was confirmed
according to the Center for Disease Control and Prevention (CDC) guidelines,
when at least one of the following criteria was present: growth of a
microorganism in bone or soft tissue culture of intraoperative samples,
histopathological analysis compatible with osteomyelitis of intro-operative
bone samples, and at least two of the clinical criteria mentioned above
(Centers for Disease Control and Prevention, 2016). Injuries of more than 3 months of evolution from onset
or initial surgery were defined as chronic (Hotchen et al., 2017).
The data obtained for this initial sample were cross-checked against medical
records and radiographic images kept at our institution to select the final
cohort. This study was conducted with the approval of our institution's
ethics committee.
We included patients aged ≥18 years old with a CPTO diagnosis of the
femur or tibia treated with antibiotic cement-coated intramedullary nailing
and a minimum follow-up of 24 months after nailing.
Exclusion criteria involved patients whose histopathological diagnosis of
osteomyelitis (based on intraoperative samples) could not be confirmed on
medical records, and those with non-union at the time of antibiotic nailing
or segmental bone defects (SBDs) secondary to debridement or injury
were excluded (Cierny–Mader type IV osteomyelitis) (Cierny et al., 2003).
Treatment protocol
Each case was analyzed separately. The surgery started with the removal of
the previous osteosynthesis material. According to the preoperative plan, we
made a bony window where the bone was most affected (e.g. sequestrum) and
performed an aggressive surgical debridement, resecting sequestra, cloacae,
and devitalized tissue until healthy bleeding (paprika sign) was reached
(Tetsworth and Cierny, 1999; Patzakis and Zalavras, 2005; Simpson et al., 2001;
Blanchette et al., 2018). The medullary cavity was progressively reamed and
washed with 6 L of saline solution (Tetsworth and Cierny, 1999; Beals and
Bryant, 2005). We took multiple (at least five) bone samples – including reamed
material – for the histopathological analysis, culture, and antibiotic
sensitivity test (Morgenstern et al., 2018; Chadayammuri et al., 2017; Hake
et al., 2015). Afterwards, we implanted an antibiotic-coated nail 1.5–2 mm
smaller in diameter than the last reamer used. When the last reamer was ≤13 mm, the metal core selected was an Ender nail (5 mm). When the last reamer
was larger, an interlocking nail was implanted.
After surgery, patients were started on empirical systemic antibiotics
(vancomycin 1 g/12 h; ceftazidime 2 g/8 h) until they were switched to
specific ones according to culture results of intra-operative samples.
According to the procedures of our institution, intraoperative samples were
processed within 6 h. This process started with the homogenization of
the tissues in brain–heart infusion (BHI) broth, and then they were inoculated on
aerobic and anaerobic sheep blood agar, chocolate agar, and thioglycolate
broth. Aerobic and anaerobic plates were incubated aerobically at
37 ∘C in 5 %–7 % CO2 for 7 d and anaerobically at
37 ∘C for 14 d. Samples in thioglycolate were incubated for 14 d and sub-cultured on blood agar. Identification of germs that grew on
the plates and antibiograms was performed with standard techniques.
Clinical and radiological controls were performed on weeks 3 and 6, on
months 3, 6 and 12, and annually thereafter. Our institution's infectious
disease department was in charge of antibiotic treatment and monitoring.
Images showing how ATB nails were manufactured in the
operating room. (a) Preparation of the plastic chest tubes and the
syringe for cement insertion. (b) Ender nail insertion into the
cemented tube. (c) Insertion of the nail into the cemented tube and
pines into the locking holes. (d, e) Images of the nail completion.
Nail coating technique
In order to design the metal core, plastic chest tubes of different
diameters were used as molds based on preoperative planning and the diameter
of the medullary canal. In all cases, the tube inner diameter was at least
2–3 mm larger than the diameter of the nail to be used. The tube was filled
with antibiotic cement, and the nail was inserted. In the case of
interlocking nails, a Steinmann pin was passed through the nail locking holes before
adding the cement. The tube was allowed to set, sectioned lengthwise, and
removed (Fig. 1). Physicians used Simplex cement (Stryker; Mahwah, NJ, USA)
to manufacture the nails, adding vancomycin 2 g and gentamicin 0.5 g/40 g of cement.
Commercial nails (Subiton, Laboratorios SL, Buenos Aires, Argentina) had a
stainless-steel core, interlocked, with 1 mm of gentamicin-impregnated cement
(according to the manufacturer's specifications). According to medical
records, surgeons used five nails with 665.0 mg of gentamicin, four with
698.1 mg, two with 732.6 mg, two with 642.4 mg, and one with 777.1 mg.
Definitions
Treatment was defined as successful when the infection was eradicated and
the patient showed no clinical, laboratory, or radiographic signs or
symptoms of infection for at least 24 months.
Additional procedure was defined as any reoperation performed after
placement of the antibiotic-coated nail. Infection recurrence was defined as
an initially controlled infection that relapsed and required new surgical
treatment and nail exchange with or without systemic antimicrobial therapy.
(Hake et al., 2015; Tice et al., 2003). Treatment failure was defined as the
absence of infection control at the end of follow-up.
Variables analyzed
We analyzed patients' demographics, comorbidities, and relevant data about
initial injury. Patients were classified using the Cierny–Mader
classification based on comorbidities and osteomyelitis characteristics
(Cierny et al., 2003).
We recorded all intraoperative complications related to the removal of the
previous implant and the bone window, as well as the antibiotic used in the
cement of custom-made nails manufactured in the operating room (Ender or
interlocking nail) and in commercial nails, the soft tissue coverage
procedures, operating time, and the results of intraoperative cultures.
Infection-related laboratory markers were also documented: erythrocyte
sedimentation (ESR), normal value (nv) <16 mm/h; C-reactive protein
(CRP), nv: <0.3 mg/dL, and white blood cell count (WBC), nv: <9000/mm3, at the time of treatment and on the last control in patients'
clinical records. The development, if any, of antibiotic-related allergies,
nephrotoxicity, and ototoxicity was also recorded.
Infection control, reoperation, and failure rates at the end of follow-up
were also registered.
Statistical analysis
Statistical analysis was performed using GraphPad PRISM-8.2
software, Inc., San Diego, USA. Quantitative data were expressed as
median values and interquartile range (IQR), and non-continuous data were
expressed as frequency and percentage. Fisher's nonparametric or
Mann–Whitney tests were used to establish significant associations between
variables. A value of p<0.05 was considered statistically
significant.
Results
Out of the 55 patients identified in our database, 20 were excluded for
presenting non-union or segmental bone defects, two for being under 18 years
of age, two for not complying with minimum follow-up requirements, and one
for lack of histopathological confirmation of chronic osteomyelitis in
medical records.
Summary description of the preoperative characteristics,
treatment and evolution of the patients in the series.
The final series was made up of 30 patients, 27 males and 3 females,
with a median age of 33 (IQR 24–43) years. As regards pre-operative
comorbidities, 4 patients were smokers, 2 were diabetic, and 1 presented
chronic renal disease. None had a history of heart disease, anemia, poor
vascularization (chronic lymphedema, venous stasis, major vessel compromise
or arteritis), rheumatoid arthritis, immune deficiency, steroids or
immunosuppressant medication, malnutrition, drug or alcohol abuse, or body
mass index >30. Twenty-eight patients were American Society of
Anesthesiologists (ASA) I–II, and two were ASA III. Table 1 presents a
description of patients.
The femur was the affected bone in 15 cases (9/15–60.00 % open
fractures) and the tibia in 15 cases (11 open fractures, 73.3 %). All
patients had previously undergone osteosynthesis, and the most frequent
method used was intramedullary nailing (25; 83.33 %) – in four cases with
antibiotic-coated nails. The median time between initial injury and
antibiotic nail treatment was 10 (IQR 6.5–15) months. According to the
Cierny–Mader classification, 18 (60.00 %) bone infections were classified
as type 3A, 8 (26.66 %) as type 1A, 3 (10.00 %) as type 1B, and
1 (3.33 %) as 3B.
Osteomyelitis of the tibia treated with a custom-made
ATB-cemented nail at another center. (a–c) AP and lateral
radiographs showing intracanal cement debonding and clinical image with
active fistula in the leg. (d) Higher zoom image of the lateral
radiograph, to highlight the cement remnants inside the tibia. (e, f) Intraoperative images, showing the locations where the bone windows were
made (at the level of the fistula and distally for the removal of the
intracanal cement) and the cement remnants removed. (g, h) AP and
lateral radiographs at 30 months after reaming and placement of an ATB-cemented nail with infection control. (i) Good evolution of the
treatment of the soft tissue coverage defect.
Complications related to the removal of previous implants occurred in
75.00 % (three out of four) of the cases in which a custom-made antibiotic-coated
nail was removed. In these cases, there was cement debonding inside the
medullary canal, and a second bony window had to be opened for removal (Fig. 2). There were no complications related to the removal of non-coated
intramedullary nails. We recorded no fractures associated with the bony
window performed during debridement. Of the 30 patients, 13 (43.33 %)
required soft-tissue coverage procedures. Nine of these procedures were
performed on the leg (eight local muscle flaps and one cross-leg flap).
Three thigh coverage defects were treated with negative pressure wound
therapy and skin grafts.
Microbiological results
The mean number of samples sent for culture and histopathological analysis
was five (range four–eight) Microbiological analysis of intraoperative samples
revealed 28 (93.3 %) positive results, while all histopathological samples
were positive. Staphylococcus aureus was the most frequently isolated germ
(14/28; seven methicillin-resistant and seven methicillin-sensitive). Of the
14 staphylococcal infections, nine were controlled, and five required
reoperations. One out of two Pseudomona aeruginosa infections and two out of
six polymicrobial infections required reoperation. Failure occurred in a
Proteus mirabilis infection. We found no significant differences in
reoperations when infections were generated by an S. aureus vs. another
microorganism (p=0.99) or between mono- vs. polymicrobial infections (p=0.64).
Laboratory outcomes
Humoral parameters showed a significant decrease in 29 cases at the end of
the study. ESR decreased from 44.32±18.81 mm/h pre-operatively to
12.96±6.13 mm/h (p=<0.0001) at the end of the study, CRP
went from 9.15±9.96 to 0.3±0.29 mg/dL (p=<0.001), and WBC went from 13518±3155 to 7400±2068 (p=<0.0001). There were no cases of antibiotic allergy, nephrotoxicity, or
ototoxicity.
Infection control rate
The overall median follow-up was 69 (range; 45–96) months. At the end of
follow-up, 29 (96.6 %) patients were clinically well and showed no
clinical, radiological, or laboratory evidence of infection. The infection
control rate without the need for additional procedures was 70.00 %
(n=21).
Overall reoperation and failure rates
Eight (26.66 % – patients: 23 to 30) patients needed additional surgical
debridement and replacement of the antibiotic-coated nail. In two of them,
soft-tissue-covering procedures were also performed (p: 23; 27). The median
time to reoperation was 2.5 (range; 1–12) months. It should be noted that
during nail removal, two of the custom-made antibiotic-coated nails showed
nail–cement debonding. The overall rate for this complication was 62.50 %
(five out of eight). In all cases the type of nail used for reoperation was the
same as the one implanted in the first surgery. None of the patients who
underwent these procedures required another surgery. When we comparatively
analyzed the characteristics of reoperated and non-reoperated patients, we
found no significant differences in terms of age (p=0.18), sex (p=0.99), affected bone (p=0.68), open versus closed fractures (p=0.52),
number of previous surgeries (p=0.18), time from the initial trauma to
antibiotic-coated nail placement (p=0.88), presence of soft tissue
coverage defects (p=0.42), use of commercial versus custom-made nails
(p=0.99), or microorganism isolated in intraoperative samples (SA vs. other (p=0.99); mono- vs. polymicrobial p=0.64).
There was one failure (3.33 %) in a patient with a Gustilo 3B gunshot
proximal tibial fracture referred to our center with an active fistula. The
patient responded well to the initial treatment with an antibiotic-coated
nail, but 11 months later his infection recurred. When the treatment was
repeated, S. aureus was identified in addition to the infecting germ
isolated during the first intervention (Proteus mirabilis). One month before
the end of the study, (27 months after placement of the last
antibiotic-coated nail) the infection recurred, and the patient is currently
under treatment.
Commercial nails vs. custom nails
Sixteen custom-made nails were used. In 10 of these cases, the metal core
was an Ender nail, while the other 6 were treated with interlocking nails.
The remaining 14 received commercial antibiotic-coated nails (Fig. 3).
(a, b) AP and lateral radiographs of a patient with a
history of open femur fracture treated with an endomedullary nail, 15 years
of evolution. The patient had an active fistula at the level of the middle
third of the external aspect of the thigh. Note the intracanal pathological
images (white arrows). (c, d) AP and lateral radiographs 2 months
postoperatively, after treatment with the commercial nail. (e, f) Control radiographs 48 months postoperatively with infection control.
In this series, the comparative analysis between custom-made and commercial
nails showed no significant differences in preoperative variables (Table 2).
Comparative analysis between patients treated with
custom-made and commercial nails.
Overall (n 30)Custom-made (n 16)Commercial nails (n 14)p<0.05Gender (male) n (%)27 (90)16 (100)11 (78.57)0.09Age median (IQR)33 (24–43)32.5 (24–45)34 (30.5–42.5)0.7Risk factors n (%) Diabetes2 (6.66)1 (6.25)1 (7.14)0.9Smoking4 (13.33)3 (18.75)1 (7.14)0.6CRD11–0.9ASA I–II28 (93.33)15 (93.75)13 (92.85)0.9ASA III–IV2 (6.66)1 (6.25)1 (7.14)Bone – open fracture nFemur15–99–66–30.3Tibia15–117–59–60.3Number of previous surgery median (range)3 (1–10)2.5 (2–9)3 (1–10)0.7Previous osteosynthesis type n (%)301614–IMN25 (83.33)14–2* (87.5)11–2* (78.57)EF3 (10)1 (6.25)2 (14.28)Plate2 (6.66)1 (6.25)1 (7.14)Months from injury to ATB nail median (IQR)10 (6.5–15)9.5 (6.5–12)12 (6–20.7)0.18Cierny–Mader n (%) 1A8 (26.66)5 (31.25)3 (21.43)0.43A18 (60.00)9 (56.25)9 (64.28)0.71B3 (10.00)1 (6.25)2 (14.28)0.63B1 (3.33)1 (6.25)–0.9ATB nail (metal core) n (%) Ender10 (33.33)10 (62.50)–Locking nail20 (66.66)6 (37.50)14 (100)ATB in PMMA n (%) Vancomycin + gentamicin16 (53.33)16 (100)Gentamicin14 (46.66)14 (100)Soft tissue coverage13 (43.33)6 (37.50)7 (50.00)0.7Surgical time median (IQR)123130.5100.5<0.001(110.3–131.8)(122.8–138)(94.2–121)Intraoperative culture n (%) MRSA7 (23.33)5 (31.25)2 (14.28)0.4MSSA7 (23.33)5 (31.25)2 (14.28)0.4Polymicrobial6 (20.00)2 (12.50)4 (28.57)0.3Culture-negativeP1-2P3-62 (6.66)1 (6.25)1 (7.15)0.9Others8 (26.66)3 (18.75)5 (37.71)0.4Infection control n (%)29 (96.60)15 (93.7)14 (100)0.9Reoperation n (%)8 (26.66)4 (25.00)4 (28.57)0.9Failure n (%)1 (3.33)1 (6.25)–0.9Follow-up months, median (IQR)6560.564.50.8(45–96)(42.7–105.5)(44.2–91.7)
CRD: chronic renal disease. *: ATB nail. IMN:
intramedullary nail. EF: external fixation. Gent:
gentamicin. Van: vancomycin. MRSA: methicillin-resistent
Staphylococcus aureus. MSSA: methicillin-sensitive Staphylococcus aureus. P1: MSSA +Enterococcus cloacae.
P2: MRSA +Proteus mirabilis+Klebsiella blee. P3: P. aeruginosa+ CoNS + MSSA.
P4: CoNS +Proteus mirabilis.
P5: P. aeruginosa+Enterococcus cloacae.
P6: MRSA +Klebsiella blee. The p value
corresponds to the comparative analysis between custom-made and industrial
nails.
We found no significant differences between nail types in terms of infection
control (p=0.99), reoperation rates (p=0.99), or failure rates (p=0.99).
Discussion
The main study finding is that infection control in CPTO was achieved in
96.66 % of the patients using antibiotic cement-coated nails.
The use of antibiotic-loaded cement or PMMA has proven effective to
administer local antimicrobials, fill voids, and achieve >90 %
healing rates in infected joint replacements (Hanseen, 2005).
Antibiotic-coated nails present an alternative to extend this concept and
represent a successful therapeutic option widely supported by the literature
(Beals and Bryant, 2005; Qiang et al., 2007; Thonse and Conway, 2007).
Several manufacturing techniques have been described for these devices, like
using pins, rods, and flexible or locking nails (Patzakis and Zalavras, 2005;
Gosselin et al., 2004; Paley and Herzenberg, 2002). These techniques offer
the advantage of delivering high doses of antibiotics locally, with few or
no systemic adverse effects (Zalavras et al., 2004). The peak of antibiotic
elution is reached 24 h after placement and remains stable until day 10.
This elution is maintained at high doses until week 10 and may persist in
lower concentrations for up to 36 weeks (Nelson et al., 1994). In addition,
interlocking nailing also provides mechanical stability, if needed (Thonse
and Conway, 2007).
Conway et al. (2014) published a series of 43 patients with infected
long-bone non-unions (Cierny–Mader type IV) treated with custom-made
antibiotic-coated nails. They reported 100 % consolidation and infection
control with a reoperation rate of 40 %, mostly related to SBDs. The fact
that we excluded type IV osteomyelitis – which requires a greater number of
surgeries for bone reconstruction – may account for the difference in
reoperation rates.
Jorge-Mora et al. (2019) analyzed a series of 10 PTO patients treated with
commercially available antibiotic-coated nails (the same used for our
series). They reported infection control in all cases, with only one
reoperation. Even though we observed no failures with this type of
antibiotic-coated nail, we found a higher reoperation rate.
Shyam et al. (2009) reported on 25 patients with infected non-union of the
femur and tibia treated with antibiotic-coated Ender nails. They described
100 % infection control and a need for subsequent nail replacement in 10
(40 %) patients. In our series, we used 10 Ender nails in consolidated
fractures and observed a 20 % (2 out of 10) need for additional procedures
because of lack of infection control.
In more than 83 % of the cases in our series, CPTO occurred after nailing.
In these cases, infection control results were similar to those described by
Qiang et al., 2007), who reported a success rate of 94.7 % (19 patients)
using antibiotic cement-coated pins. These authors recommend the use of
external fixation in case of non-union with this type of metal core. We
agree with these authors that the use of an Ender nail or a non-locking nail
in cases of infected long bone non-union or SBDs requires another device to
provide stability, which represents a limitation in this indication.
Another treatment option with recently reported good results for medullar
cavity reaming and lavage is the combined use of the
reamer–irrigator–aspirator (RIA) system and antibiotic-coated nails
(Kanakaris et al., 2014; Finelli et al., 2019). By using the RIA system,
surgeons do not need to create a bone window, and, therefore, the procedure
morbidity is reduced. Still, we found no such complication in our series.
Eight (26.66 %) patients in our series required a new intervention to
control an infection. Reoperations were more frequent (though not
significantly) when the affected bone was the tibia (n=5; 62.50 %), the
original injury was an open fracture (n=6; 75.00 %), soft tissue defects
were present (n=5; 62.50 %), and the isolated germ was S. aureus (n=5;
62.50 %). Our reoperation rate was similar or even lower than the
20 %–40 % reported by previous series (Shyam et al., 2009; Garcia et al.,
2018).
We understand that surgical debridement is essential to treat osteomyelitis
successfully. Therefore, insufficient debridement could account for our
reoperation rates. Simpson et al. (2001) demonstrated that a vital bone
resection margin reduces the possibility of recurrence. Although we found no
significant differences between reoperated and non-reoperated patients in
terms of isolated microorganism, this could have an effect on reoperation
rates. In our analysis, 50 % (1 out of 2) P. aeruginosa and 35.71 % (5
out of 14) S. aureus infections recurred, which is consistent with the
findings of Tice et al. (2003), who reported P. aeruginosa infections are
associated with a higher risk of recurrence than S. aureus. On the other hand,
Jorge et al. (2018) reported that polymicrobial PTO is associated with worse
outcomes. In our series, 33.33 % (2 out of 6) polymicrobial infections
needed reoperation.
The population analyzed in this series and treated either with custom-made
or commercial antibiotic-coated nails obtained similar results, and we
observed no significant differences in their preoperative characteristics.
In our analysis, devices manufactured in the OR were associated with longer
operating times and some difficulties at the time of nail removal due to
nail–cement debonding. While other authors have reported a 20 % incidence
of this complication (Wasko and Borens, 2013; Thonse and Conway, 2007; Shyam
et al., 2009), it was more than 3 times higher in our series, as
fragment extraction added to the complexity of the procedure and the need
for an extra bone window. On the other hand, commercially available nails
were easier to remove and did not show nail–cement debonding, possibly due
to the greater strength of the cement used in their manufacturing process.
Finally, we found no significant differences between the two types of nails
in terms of infection control and need for reoperation.
The limitations of this study are those inherent to retrospective studies
with a small sample. This might account for the lack of statistical
significance of some of the variables analyzed producing a type 2 error.
This number was limited as we excluded Cierny–Mader type IV osteomyelitis
cases to obtain a more homogeneous population – especially with regard to
procedures related to SBD reconstruction. Another limitation is the lack of
a control group or functional analysis. On the other hand, the strengths of
this study include the detailed characterization of patients with a complex
and difficult to treat condition such as CPTO using antibiotic-coated nails.
The literature does not include many comparative studies on the results of
patients treated with commercial nails versus those treated with custom-made
nails. Finally, our study presents an acceptable follow-up (minimum of 24 months) considering most recurrences occur during the first postoperative
year.
Conclusion
Along with the classic treatment pillars for chronic osteomyelitis, the use
of antibiotic cement-coated nails proved useful in the challenging treatment
of post-traumatic chronic osteomyelitis. Our comparative analysis of
custom-made and commercial antibiotic-coated nails did not show significant
differences in terms of infection control and reoperation rates for
patients without non-union or segmental bone defects. However, the use of
custom-made nails made in the operating room was associated with longer
operating times and nail–cement debonding at the time of extraction. In
order to determine the external validity of this study, it is necessary to
conduct properly designed studies in a larger population.
Ethical statement
This retrospective chart review study, involving
human participants, was in accordance with the ethical standards of the
institutional and national research committee and with the 1964 Helsinki
Declaration and its later amendments. The Bioethics Committee of British
Hospital of Buenos Aires approved this study (protocol number 853). Personal
information was removed from any published material, in agreement with the
guidelines of the European General Data Protection Regulation, so as to
protect the privacy of patients.
Data availability
All data generated and analyzed during this
study are included in this published article and are available from the
corresponding author on reasonable request.
Author contributions
All authors contributed to the study
conception and design. Material preparation, data collection, and analysis
were performed by GG, LPA, JAR, HdS, and CAP. The first draft of the
manuscript was written by GG, and all authors commented on previous versions
of the manuscript. All authors read and approved the final paper.
Competing interests
The contact author has declared that neither they nor their co-authors have any competing interests.
Disclaimer
Publisher's note: Copernicus Publications remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Review statement
This paper was edited by Parham Sendi and reviewed by two anonymous referees.
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