Introduction: Infected non-union of bones shows problems in providing stability and controlling the infection. The treatment comprises debridement with or without the use of antibiotic cement and achieving stability by either external or internal fixation with or without bone grafting. The use of antibiotic-impregnated cement-coated intramedullary nailing gives stability and treats the infection, thereby permitting early mobilization. External fixation is a definitive mode of fracture stabilization indicated in cases of infected non-unions of the humerus, tibia, and juxta-articular bone. The present study was conducted to compare the results of management of infected non-union long bones treated with an external fixator (Ilizarov and Limb Reconstruction System (LRS)) and vancomycin-coated intramedullary nail. Materials and method: The present prospective study was conducted on 40 study subjects aged >18 years, and were randomly divided using the alternative method into two groups. Group A: 20 Patients were treated with antibiotic-coated intramedullary interlocking nail (ACIIN). Group B: 20 patients were treated with the external fixator (LRS/Ilizarov). All patients were then evaluated post-operatively using laboratory investigations, and for any sign of inflammation or infection. Results were evaluated using association for the study and application of methods of Ilizarov (ASAMI) scoring system. Data were analyzed using the Statistical Package for Social Sciences (SPSS) version 20 (IBM Corp., Armonk, NY, USA). Results: It was observed that 80.0% of patients in Group A, and 70% of subjects in Group B showed bony union, revealing a statistically significant (p-value<0.05) difference. Infection control, limb length discrepancy, and deformity were also assessed in both groups. Bone and functional outcomes were assessed using the ASAMI score in both groups. In LRS/Ilizarov, it was observed that 55% of subjects had no infection, 15% showed loosening, and 30% had an infection. Conclusion: The ACIIN should not be used for bone defects more than 4 cm as it does not achieve stability and for these cases, procedures like external fixators (Ilizarov and LRS) should be used. Antibiotic-coated nail eliminated the complications of the external fixators like pin loosening, and pin infections and was technically less demanding. In our study, stiffness of adjacent joints was more in external fixators (LRS/Ilizarov) than ACIIN.
Both acute and long-term injuries have a substantial impact on morbidity and a lower standard of living. A significant risk of hospitalisation, amputation, sepsis, and even death, they affect at least 1% of the population. Large wounds continue to be difficult for medical personnel to manage, causing patients' agony and anguish in addition to financial hardship.
[1-3] A major worry is delayed wound healing, particularly in complex wounds and in older people with comorbidities. It puts a significant social and financial burden on patients by causing pain, requiring extensive reconstructive surgery, increasing morbidity, and prolonging treatment. When using traditional dressing approaches to treat open wounds, there can be serious consequences. Based on a study using a porcine model, Morykwas and Argenta introduced vacuum-assisted closure (VAC) in 1997. Extensive clinical and experimental research has assessed this technology over the last 20 years, showing that it is successful in treating both acute and chronic wounds. In order to reduce wound size, VAC therapy draws the borders of the wound together. It also promotes the production of granulation tissue for skin grafting, improves microcirculation, lowers oedema, and gets rid of infectious tissues.
[4-7] Despite the fact that wound dressings have been used for more than two millennia, there is currently no universally accepted optimal dressing. Tradition, clinical experience, and the surgeon's own style all play a significant role in the choice of surgical dressings for both open and closed wounds. Only a small number of moist dressings and topical medications used in modern wound-healing techniques have been shown to considerably increase wound closure rates when compared to conventional wet gauze dressings. Many novel dressings have been developed throughout the last 20 years. One method that has shown promise in promoting quicker healing and accelerating the production of granulation tissue is negative pressure wound therapy. In big wounds, this method efficiently shortens the interval between debridement and final surgical closure. [8-10] The purpose of this study was to assess the efficacy of VAC dressings to conventional wound dressings in the healing of chronic wounds. If, after 4–12 weeks of treatment, a wound has not begun to heal, it is deemed chronic. Usually, poor blood circulation, diabetes, or a weakened immune system cause these kinds of wounds. [11]
Study setting
A Hospital-based comparative, observational study was conducted in the department of Orthopedics of Amaltas Institute of Medical Sciences (AIMS), Dewas.
The current prospective study involved 20 study participants, all over the age of 18, who had non-union, infected long bones with a fracture at the diaphysis and normal neurological and vascular status. The participants were seen in the department of orthopaedics at the Amaltas Institute of Medical Sciences in Dewas, Madhya Pradesh, India. The study excluded patients who were skeletally immature, on immunosuppressive medication therapy, had neoplasia, mental health problems, auto-immune illnesses, or were unwilling to engage in extended post-operative rehabilitation. All patients provided written informed consent, and the trial was carried out with institutional ethics committee approval.
After completing a pre-operative evaluation, all subjects were split into two groups at random using the alternate approach. Group A: Ten patients received intramedullary interlocking nails (ACIIN) coated with antibiotics. Group B: LRS external fixators were used to treat 10 patients.
Since gentamycin, vancomycin, and combined vancomycin coated intramedullary interlocking nails have good elution qualities, heat stability, and broad spectrum activity, they were employed. Patients in the external fixator group had Ilizarov or LRS fixators installed based on the needs of the surgical procedure. Using a lot of lavage, the contaminated bone and soft tissue were thoroughly debrided. Following that, the intramedullary canal was suitably cleansed and ready to accept the larger diameter nail using conventional technique.
On a different sterile surface, an adequate size of the interlocking nail impregnated with antibiotic was manufactured. Up to one millimetre less bone cement was applied to the intramedullary interlocking nail than the final reamer. A doughy mixture of cement and antibiotics was then poured into a plastic tube whose internal diameter matched the desired diameter of the cement-coated nail. After that, the nail was forced into the tube and let ten to fifteen minutes to set. After that, a surgical knife was used to cut up the plastic tube and remove the intramedullary interlocking nail that had been evenly covered in antimicrobial cement. The locking wall's holes remained unplugged.
After that, the nail was put in an antegrade manner. By giving the cement insufficient time to solidify and form a bond with the nail and by creating tiny serrations on the nail's surface, nail cement debonding during insertion was prevented.
Laboratory studies were used to assess all patients for signs of infection or inflammation following surgery. Depending on how well the fracture was mending, physiotherapy was initiated and systemic antibiotics were provided. Every patient underwent follow-up for a year, or until bony union, whichever came first.
The ASAMI rating system from their previous visit was used to assess the findings. According to Paley et al., the ASAMI scoring system yielded results ranging from excellent (bony union free of infection and joint stiffness) to bad (non-union with infection and deformity).[16]
Every piece of information was gathered using a pre-made proforma. Using the Statistical Package for Social Sciences (SPSS) version 20 (IBM Corp., Armonk, NY, USA), data were analysed using the necessary statistical tests. P-values less than 0.05 were regarded as significant. The mean, standard deviation, and frequencies were computed using descriptive analysis.
The largest number of patients (50%) in Group A were between the ages of 41 and 60, while the maximum number of patients (50%) in Group B were between the ages of 21 and 40, with a preponderance of men in both groups. It was shown that the majority of patients in Groups A and B (70–80%) had tibia involvement, with a predominance of the right side. Road traffic accidents were the most frequent cause of injury, occurring in 80% and 65% of patients in Groups A and B, respectively.
Seventy percent of patients in Group A had had one surgical procedure, while eighty percent of patients in Group B had had two surgical procedures. In both groups, the mean length of infection, bone union, bony defect, and shortening were assessed.
TABLE 1: Mean of various parameters in both the groups
Parameters |
Group A (ACIIN)<br>Mean ± SD |
Group B (LRS)<br>Mean ± SD |
t-test |
P-Value |
Duration of infection (months) |
7.2 ± 2.1 |
8.0 ± 1.9 |
1.54 |
0.13 |
Duration of bony union (weeks) |
24.5 ± 3.2 |
30.1 ± 4.0 |
5.87 |
<0.001 |
Bone defect (cm) |
3.6 ± 1.0 |
4.2 ± 1.2 |
2.01 |
0.048 |
Shortening (cm) |
1.2 ± 0.5 |
1.6 ± 0.7 |
2.52 |
0.014 |
TABLE 2: Distribution of study subjects according to the type of previous surgery done in both groups
Previous surgery done |
Group A (ACIIN) |
Group B (LRS) |
Closed reduction with Intra-medullary nail |
01 |
01 |
Closed reduction with External fixato |
01 |
02 |
Debridement with Plating |
02 |
01 |
Debridement with Intra-medullary nai |
02 |
02 |
Debridement with External fixator |
02 |
03 |
ORIF with Intra-medullary nail |
01 |
00 |
ORIF with Plating |
01 |
01 |
Total |
10 |
10 |
TABLE 3: Distribution of study subjects according to treatment done in both the group
Treatment |
Bony Defect (cm) |
Number of Cases Treated |
Number of Cases Showing Bony Union |
Percentage (%) |
ACIIN |
< 3 cm |
05 |
05 |
100% |
ACIIN |
3–5 cm |
04 |
03 |
75% |
ACIIN |
> 5 cm |
01 |
00 |
0% |
Total (ACIIN) |
— |
10 |
08 |
80% |
LRS |
< 3 cm |
02 |
02 |
100% |
LRS |
3–5 cm |
05 |
04 |
80% |
LRS |
> 5 cm |
03 |
02 |
66.7% |
Total (LRS) |
— |
10 |
08 |
80% |
TABLE 4: Distribution of study subjects according to ankle and knee mobility in both groups
|
Knee mobility |
Ankle mobility |
||
|
Group A (ACIIN) |
Group B (LRS) |
Group A (ACIIN) |
Group B (LRS) |
|
Frequency (%) |
Frequency (%) |
Frequency (%) |
Frequency (%) |
Normal |
8 (80%) |
5 (50%) |
9 (90%) |
6 (60%) |
Stiff |
2 (20%) |
5 (50%) |
1 (10%) |
4 (40%) |
Total |
100 |
100 |
100 |
100 |
P-value |
0.20 |
0.143 |
It was observed that 80% of patients in Group A and 70% of subjects in Group B showed a bony union, revealing a statistically significant (p-value <0.05) difference. Infection control, limb length discrepancy, and deformity were also assessed in both groups (Table 5)
It was observed that 80% of patients in Group A and 70% of subjects in Group B showed a bony union, revealing a statistically significant (p-value <0.05) difference. Infection control, limb length discrepancy, and deformity were also assessed in both groups (Table 5)
It was observed that 80% of patients in Group A and 70% of subjects in Group B showed a bony union, revealing a statistically significant (p-value <0.05) difference. Infection control, limb length discrepancy, and deformity were also assessed in both groups (Table 5)
TABLE 5: Distribution of study subjects according to post-operative assessment parameters in both the group
Infection Control |
Group A (ACIIN) |
Group B (LRS) |
Frequency (%) |
Frequency (%) |
|
Controlled |
9 (90%) |
8 (80%) |
Not Controlled |
1 (10%) |
2 (20%) |
Total |
10 (100%) |
10 (100%) |
P-value |
0.531 |
LLD Range |
Group A (ACIIN) |
Group B (LRS) |
< 1 cm |
6 (60%) |
4 (40%) |
1–2 cm |
3 (30%) |
4 (40%) |
> 2 cm |
1 (10%) |
2 (20%) |
Total |
10 (100%) |
10 (100%) |
TABLE 6: Distribution of study subjects according to the ASAMI score on bone and functional outcomes in both groups
ASAMI Score |
Bone Outcome – Group A (ACIIN) Frequency (%) |
Bone Outcome – Group B (LRS) Frequency (%) |
Functional Outcome – Group A (ACIIN) Frequency (%) |
Functional Outcome – Group B (LRS) Frequency (%) |
Excellent |
5 (50%) |
3 (30%) |
4 (40%) |
2 (20%) |
Good |
3 (30%) |
4 (40%) |
4 (40%) |
4 (40%) |
Fair |
1 (10%) |
2 (20%) |
1 (10%) |
2 (20%) |
Poor |
1 (10%) |
1 (10%) |
1 (10%) |
2 (20%) |
Total |
10 (100%) |
10 (100%) |
10 (100%) |
10 (100%) |
P-value |
0.56 |
0.47 |
TABLE 7: Distribution of infective organisms in both groups
Infective Organism |
Group A (ACIIN) |
Group B (LRS) |
Staphylococcus aureus |
5 |
4 |
Pseudomonas aeruginosa |
2 |
3 |
Klebsiella |
1 |
1 |
Escherichia coli |
1 |
1 |
Mixed flora |
1 |
1 |
Total |
10 |
10 |
Radical debridement of the sinus tracts, deadbone, and fibrous tissue is necessary for treating infected non-union of the long bones until the paprika sign develops and firm fixation is accomplished. When it comes to minimising adverse effects, local antibiotics are preferable to systemic ones.[17]
According to the findings of Bhatia et al.'s research, Staphylococcus aureus was the primary source of infection in long bones, as we saw in this study. [18] and Thonse et al. [6]. Antibiotics with a broad spectrum of action should be administered to eradicate these illnesses. Due to its heat-stable physical qualities, vancomycin is an excellent choice for loading bone cement in the current work, where it was combined with gentamicin. Bacteriocidal in nature, vancomycin works by preventing the creation of the cell wall. Numerous trials that were similar to ours combined vancomycin with either gentamicin or teicoplanin.[8] [19].
Shyam et al. carried out a trial that was comparable to ours in which they treated infected non-union long bones with the ACIIN. They came to the conclusion that in cases of infected non-union with a bone defect <6 cm, ACIINs are helpful for infection management and bone union. They promoted the employment of other options in cases where faults measured more than 6 cm.[20]. In a similar vein, Bhatia et al. investigated the function of antibiotic cement-coated nailing in tibia infections that did not heal. Sixty percent of patients with bone abnormalities less than two centimetres were able to achieve bony union; the average union duration was thirty-two weeks.[18] Procedures like bone grafting or exchange nailing were necessary for the remaining patients whose bone lesions measured more than 2 cm. They noticed several consequences, such as twisted, broken, or difficult-to-remove nails, as well as infection recurrence. Maini et al. successfully united bone lesions ranging from 4 to 15 cm by using Ilizarov. Antibiotic-coated intramedullary interlocking nails (ACIIN) had an 80% success rate in preventing infections.[21] Infection control was likewise accomplished in 84% of the cases by Thonse et al.[6]
According to a number of studies, using external fixators is linked to problems such a high risk of pin infections, pin loosening, patient noncompliance, joint stiffness, and muscle contractures. [22,23]. Our current study found that 15% of patients experienced pin loosening, 30% had pin infections, and 25% had joint stiffness. These findings are consistent with previous research. It was shown that the average length of a bony union was 31 weeks.
In the aforementioned investigations, the bone and functional results were assessed using the ASAMI grading system. Our study's findings were similar to those of the previous research. [24-27]
According to a study by Hernigou et al., smoking significantly affects bone non-union and is predictive of a poor prognosis for diaphyseal fracture healing.[28] According to Gortler et al., diabetes significantly affects soft tissue repair and bone metabolism, increasing the risk of poor fracture healing and other issues. They found that across a wide range of surgically treated lower extremity fractures, diabetes can considerably raise the chances of infection, malunion, non-union, and re-operation. [29] Clinicians can use this study's prognostic data to help guide the treatment of the study population.
Due to the small sample size in our investigation, we were unable to fully eliminate all confounding variables. We were unable to obtain a higher number of cases due to the relative rarity of cases involving infected non-unions. These examples came together to form a diverse group. Furthermore, the ACIIN group employed varying amounts of antibiotic in bone cement, contingent on the bone's canal diameter where the nail was being placed.
For bone defects smaller than 4 cm, the antibiotic nail is a single-stage surgery that achieves both infection control and union. According to our research. For bone defects larger than 4 cm, ACIIN should not be used because it does not provide stability in these circumstances. Instead, external fixators (LRS/Ilizarov) should be employed.An antibiotic-coated nail proved technically less demanding and prevented pin infections and loosening that can occur with external fixators.
In our investigation, external fixators (LRS/Ilizarov) had higher stiffness in nearby joints than did ACIIN. Compared to external fixators, infection management in ACIIN was only slightly improved. According to our research, ACIIN led to bone union earlier than external fixators (LRS/Ilizarov). Long bone non-union and delayed growth appear to be significantly impacted by diabetes and smoking. immobilization and non-union of fractures.