Comparative Analysis of Secondary Outcomes in Treatment of Charcot Neuropathy: A Systematic Review

Abstract

Background:

Charcot neuroarthropathy (CN) is commonly associated with diabetic neuropathy and can predispose patients to amputations. Management remains a challenge, with no definitive treatment. This study examines major postoperative complications associated with open reduction with internal (intramedullary) nails, fixation, external fixation, or combined internal and external fixation for correction of the deformity.

Methods:

We reviewed available literature using PubMed, OvidSP, Scopus, and Cochrane and searched bibliographies of the included studies to identify additional pertinent references. After review and agreement among 4 raters, a total of 15 studies were included in this analysis.

Results:

Hardware removal rates were 0.133 for intramedullary nails, 0.007 for external fixators, and 0.050 for combined fixation. Rates of hardware complication were 0.182 for intramedullary nails and 0.007 for external fixators. Wound dehiscence occurred at rates of 0.059 for intramedullary nails and 0.216 for combined fixation. The rate of deep infections was 0.031 for intramedullary nails, 0.032 for external fixators, and 0.113 for combined fixation. The rate of irrigation and debridement was 0.007 for external fixators.

Conclusion:

Rates of hardware removal (13.3%) and complications (18.2%) were high with intramedullary nails. Dehiscence (21.6%) and deep infection (11.3%) were high in combined fixation. Other complications occurred relatively rarely.

Level of Evidence:

Level III

Keywords

Charcot’s joint diabetic foot diabetic neuropathy external and internal fixators postoperative complications

“We compare rates of hardware removal, deep infection, hardware complications, and wound dehiscence among the following 3 techniques for correction of deformity: open reduction with internal (intramedullary [IM] nail) fixation, external fixation, and combined internal and external fixation.

Introduction

According to 2018 statistics released by the U.S. Centers for Disease Control, 34.2 million Americans (10.5% of the population) have diabetes.¹ Due to complications such as Charcot neuropathy of the foot (CN), a condition commonly associated with diabetic neuropathy, diabetes is now the primary cause of lower extremity amputation in the United States.¹ CN affects the bones, joints, and soft tissues, causing pathological architecture changes which include deformity, subluxation, and ulceration.² The true prevalence of CN is unknown, but is estimated as being between 0.8% and 8% of the diabetic population.³ While the pathophysiology of CN is still being studied, one theory suggests that initial microtrauma in a lower extremity that has lost protective sensation can result in an abnormal distribution of forces on the bone and joints. This leads to an unregulated immune response and dysregulated osteoclastic activity, ultimately resulting in destruction of the articulation.^4–6

Management of CN remains a challenge. Conservative, nonoperative treatment of CN consists of total contact casting, which attempts to achieve stability and is modified according to the patient’s Eichenholtz classification.⁷ Total contact casting helps to reduce mechanical forces, inflammation, and edema, and redistributes the plantigrade pressure on the deformity.⁸ Surgical treatment options include exostectomy, arthrodesis, and amputation of the affected extremity.⁷ This review focuses on surgical stabilization techniques used to achieve arthrodesis in CN.^9–13 This data can serve as a guide to choosing an optimal procedure and suggest further research into elucidating risk factors for these complications.

Methods

We undertook a systematic review of the literature using PubMed, OvidSP, Scopus, and Cochrane online databases. An inclusive search using the terms “Diabetic Neuropathies,” “Foot Deformities Acquired,” “Fracture Fixation,” “Internal Fixators,” “Bone Nails,” “Intramedullary Fracture Fixation,” “External Fixators,” and “Ilizarov Technique” was performed. A manual bibliographic search of the studies chosen for inclusion was also completed to identify any additional pertinent references. The inclusion criteria were as follows: reports published in English or translated into English in peer-reviewed medical journals between 2002 and 2020, clearly indicated complication rates for each method of Charcot foot fixation studied, a specific description of the fixation methods used, and a specific description of a patient subpopulation who all had CN.

The initial abstract review was completed by 4 raters (T.N, S.A, B.B, and A.A), with agreement by all required for final inclusion of an article in the review. The selected studies were then reviewed in detail by the 4 raters, using the same criteria as above. A total of 15 papers were included in this study (Figure 1). A description of references included in our study can be seen in Table 1.

Table 1.

Summary of the 15 Studies Reviewed.

Studies	Patients	Mean age (years)			Percentage with diabetes mellitus			Average length of follow-up
Studies	Patients	IM	EF	Combined	IM	EF	Combined	IM	EF	Combined
DeVries et al.¹³	45	59.4 ± 10.38	51.6 ± 9.8	N/A	86.70%	85.70%	N/A	101.24 ± 80.96 weeks	62.30 ± 42.10 weeks	N/A
Vitiello et al.¹¹	4	56.8	N/A	N/A	100%	N/A	N/A	59.5 months	N/A	N/A
Rogers et al.⁵	14	N/A	55.3 ± 11.9	N/A	N/A	87%	N/A	N/A	12 months	N/A
Finkler et al.¹⁴	283	N/A	55.8	N/A	N/A	100%	N/A	N/A	11 years	N/A
Hegewald et al.⁹	22	N/A	N/A	54 ± 11.4	N/A	N/A	100%	N/A	N/A	58.60 ± 42.37 weeks
Richman et al.¹⁰	26	56	57.6	N/A	94%	100%	N/A	3.6 years	2.2 years	N/A
El-Gafary et al.¹⁵	18	N/A	30	N/A	N/A	90%	N/A	N/A	20 months	N/A
Fabrin et al.¹⁶	11	N/A	61	N/A	N/A	100%	N/A	N/A	48 months	N/A
Pinzur and Norman¹⁷	9	52. 3	N/A	N/A	100%	N/A	N/A	32 months	N/A	N/A
Zarutsky et al.¹⁸	11	N/A	57.4	N/A	N/A	100%	N/A	N/A	27 months	N/A
Caravaggi et al.¹⁹	45	56 ± 11	N/A	N/A	100%	N/A	N/A	5.25 ± 2.85 years	N/A	N/A
Siebachmeyer et al.²⁰	19	62.6	N/A	N/A	95%	N/A	N/A	26 months	N/A	N/A

Abbreviations: EF, external fixation; IM, intramedullary nail.

After review, data was collected and detailed for each paper, including author, year, study design, and complication rates for subjects treated with external fixation, intramedullary nail, or combined fixation. Our primary outcomes were hardware removal and deep infections. The external fixator group consisted of external fixator removal only, whereas the combined fixation group included removal of an external fixator along with the internal fixation. Secondary complications reviewed were wound dehiscence, irrigation and debridement, and pin tract infections. Meta-analysis was carried out to synthesize results across papers using random effects models. Funnel plots were used to assess for publication bias, and forest plots were used to summarize results. All analyses were carried out using the “metafor” package within R, R Core Team (2020). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/.)

Results

Table 2 displays the rates of postsurgical complications for the 3 surgical techniques reviewed in this study.

Table 2.

Rates of Postsurgical Complications, Calculated Using Random Effects Models for Meta-Analysis.

Complications	Intramedullary nail	External fixator	Combined
Hardware removal	0.133 (0.012-0.253)	0.007 (0.000-0.025)	0.050 (0.000-0.129)
Hardware complications	0.182 (0.008-0.357)	0.007 (0.000-0.025)	0.218 (0.000-0.679)
Deep infection	0.031 (0.001-0.061)	0.032 (0.000-0.075)	0.113 (0.000-0.228)
Wound dehiscence	0.059 (0.000-0.123)	0.108 (0.000-0.270)	0.216 (0.000-0.502)
Irrigation and debridement	0.135 (0.000-0.306)	0.007 (0.000-0.025)	0.218 (0.000-0.679)
Pin tract infections	-	0.340 (0.108-0.571)	0.261 (0.000-0.636)

Intramedullary Nail

Hardware removal

The rate of hardware removal was calculated to be 0.133 (95% confidence interval [CI]; range, 0.012-0.253) for intramedullary nail, based on the data from 6 studies which examined IM. Caravaggi et al.¹⁹ had a rate of 0.16 (0.05-0.26) for hardware removal among IM nail patients. In this study, 45 patients who underwent salvage ankle arthrodesis were reviewed for their postsurgical complications over a 9-year period.

The rate of hardware removal for IM-treated patients in DeVries et al.¹³ was 0.01 (0.00-0.05). The study compared the rates of irrigation and debridement in 45 patients with an IM nail placement and 6 patients with the simultaneous implementation of an IM nail and external fixator. Twenty-two (48.89%) of the 45 patients with an IM nail placement and 3 (50%) of the 6 patients with both intramedullary nail and external fixation had to undergo irrigation and debridement. There was no significant difference in the rates of irrigation and debridement.

In their study, Pinzur and Norman¹⁷ examined 9 diabetic patients treated with a retrograde femoral intramedullary nail to determine whether the risk of a stress fracture postoperatively would decrease in patients with Charcot-related osteopenia. The rate of hardware removal was 0.05 (0.00-0.19).

Richman et al.¹⁰ observed a rate of 0.53 (0.28-0.79) for hardware removal among intramedullary nail patients. This study compared limb salvage rates in patients with either retrograde intramedullary nail or ring external fixation. Seven out of the 15 patients (47%) treated with intramedullary nail required removal of the implant, compared to 1 out of 11 patients (9%) treated with ring fixator only. Complications occurred at an average of 117 weeks postoperatively. Limb salvage rate was comparable between the 2 groups, with 10 out of 16 (63%) in the intramedullary nail group and 7 out of 11 (64%) in the external ring fixator group achieving limb salvage.

In Siebachmeyer et al.,²⁰ 2 hardware removals were noted in 19 Charcot foot patients who were treated with an intramedullary nail. One of the patients developed an ulcer on the sole at the site of nail insertion. Another patient had a broken nail that required surgical removal. This yielded a rate of 0.11 (0.03-0.24) for hardware removal.

Vitiello et al.¹¹ conducted a retrospective study of intramedullary nailing in 12 diabetic patients and found a rate of 0.10 (0.00-0.36) for hardware removal. Of these patients, 4 had CN (33.33%), and out of these 4 patients, 1 exhibited wound dehiscence (25%).

Hardware complications

The rate of hardware complications was 0.182 (0.008-0.357) for intramedullary nails. Caravaggi et al.¹⁹ had a rate of 0.01 (0.00-0.04) for hardware complications in intramedullary nail patients. DeVries et al.¹³ had a rate of 0.59 (0.44-0.74), Pinzur and Noonan¹⁷ had a rate of 0.05 (0.00-0.19), Richman et al.¹⁰ had a rate of 0.20 (0.00-0.40), Siebachmeyer et al.²⁰ had a rate of 0.16 (0.01-0.32), and Vitiello et al.¹¹ had a rate of 0.10 (0.00-0.36).

Wound dehiscence

The rate of wound dehiscence was 0.059 (0.000-0.123) for intramedullary nails. Caravaggi et al.¹⁹ had a rate of 0.22 (0.10-0.34) for wound dehiscence in intramedullary nail patients. Devries had a rate of 0.01 (0.00-0.05), Pinzur and Noonan^14,17 had a rate of 0.05 (0.00-0.19), Richman et al.¹⁰ had a rate of 0.03 (0.00-0.12), Siebachmeyer et al.²⁰ had a rate of 0.03 (0.00-0.09), and Vitiello et al.¹¹ had a rate of 0.25 (0.00-0.67).

Deep infections

The rate of deep infections was 0.031 (0.001-0.061) for intramedullary nail. For deep infections, Caravaggi et al.¹⁹ had a rate of 0.04 (0.02-0.10) for intramedullary nail patients. Devries had a rate of 0.01 (0.00-0.05), Pinzur and Noonan¹⁷ had a rate of 0.11 (0.00-0.32), Richman et al.¹⁰ had a rate of 0.40 (0.15-0.65), Siebachmeyer et al.²⁰ had a rate of 0.03 (0.00-0.09), and Vitiello et al.¹¹ had a rate of 0.10 (0.00-0.36).

External Fixator

Hardware removal

The rate of hardware removal was calculated to be 0.007 (0.000-0.025) for the external fixator, based on the data from 6 studies.

Rogers et al.⁵ had a rate of 0.03 (0.00-0.12) for hardware removal among external fixator patients. This study reviewed 15 patients (16 limbs) with Charcot foot deformity for postoperative complications after they underwent Ilizarov external ring fixator correction. Five pin tract infections (31%) were noted, along with 4 pin fractures (25%) and 9 cases of wound dehiscence (56%).

Finkler et al.¹⁴ carried out a retrospective case series that assessed the risk of pin tract infections in diabetic patients treated with static circular external fixation for Charcot deformity, with minimal pin care. Two hundred eighty-three consecutive diabetic patients who underwent single-stage correction of Charcot foot or ankle were identified, of which 59 patients (20.8%) developed a pin-site infection in at least 1 pin site. A rate of 0.00 (0.00-0.01) for hardware removal was observed. Richman et al.¹⁰ had a rate of 0.04 (0.00-0.15) for hardware removal among external fixator patients.

El-Gafary et al.¹⁵ observed a rate of 0.03 (0.00-0.01) for hardware removal among 20 patients with stage II Charcot osteopathy of the foot and ankle who were treated with an Ilizarov external fixator. Eighteen of the patients treated were diabetic. Fifteen patients developed a pin tract infection.

Fabrin et al.¹⁶ had a rate of 0.04 (0.00-0.15) for hardware removal among external fixator patients. This study was a case series of 11 patients (12 limbs) with unstable Charcot deformity, with or without the presence of chronic pressure ulcers, over a 12-year period. Complications occurred in 1 patient who underwent limb amputation, while 5 had a pin site infection, and 1 acquired a superficial infection.

Zarutsky et al.¹⁸ had a rate of 0.04 (0.00-0.15) for hardware removal among external fixator patients in a cohort study reviewing postsurgical complications after a unilateral ankle arthrodesis in 11 Charcot foot deformity patients. Four of the 11 subjects in this study experienced severe deep infections at the surgical site, 2 of the patients underwent below-knee amputation, and a rate of 0.04 (0.00-0.15) for hardware removal was observed.

Hardware complications

The rate of hardware complications was calculated to be 0.007 (0.000-0.025) for the external fixator. For hardware complications, Rogers et al.⁵ had a rate of 0.03 (0.00-0.12) for the external fixator patients, Finkler et al.¹⁴ had a rate of 0.00 (0.00-0.01), Richman et al.¹⁰ had a rate of 0.04 (0.00-0.15), El-Gafary et al.¹⁵ had a rate of 0.03 (0.00-0.10), Fabrin et al.¹⁶ had a rate of 0.04 (0.00-0.15), and Zarutsky et al.¹⁸ had a rate of 0.04 (0.00-0.15).

Irrigation and debridement

The rate of irrigation and debridement was calculated to be 0.007 (0.000-0.025) for the external fixator. For irrigation and debridement, Rogers et al.⁵ had a rate of 0.03 (0.00-0.12) for the external fixator patients, Finkler et al.¹⁴ had a rate of 0.00 (0.00-0.01), Richman et al.¹⁰ had a rate of 0.04 (0.00-0.15), El-Gafary et al.¹⁵ had a rate of 0.03 (0.00-0.10), Fabrin et al.¹⁶ had a rate of 0.04 (0.00-0.15), and Zarutsky et al.¹⁸ had a rate of 0.04 (0.00-0.15).

Deep infections

The rate of deep infections was calculated to be 0.032 (0.000-0.075) for the external fixator. Rogers et al.⁵ had a rate of 0.03 (0.00-0.12) for the external fixator patients, Finkler et al.¹⁴ had a rate of 0.00 (0.00-0.01), Richman et al.¹⁰ had a rate of 0.18 (0.00-0.41), El-Gafary et al.¹⁵ had a rate of 0.03 (0.00-0.10), Fabrin et al.¹⁶ had a rate of 0.09 (0.00-0.26), and Zarutsky et al.¹⁸ had a rate of 0.36 (0.08-0.65).

Combined Fixation

Hardware removal

The rate of hardware removal was calculated to be 0.050 (0.000-0.129) for combined fixation, based on the data from 2 studies. DeVries et al.¹³ had a rate of 0.07 (0.00-0.26) for hardware removal among combined fixation patients. This study compared the rates of irrigation and debridement between 45 patients with an intramedullary nail placement and 7 patients with the simultaneous implementation of an intramedullary nail and external fixator. The study found that 22 of the 45 patients (48.89%) with an intramedullary nail placement, and 3 of the 7 patients (42.86%) with the implementation of both intramedullary nail and external fixation, had to undergo irrigation and debridement. There was no significant difference in the rates of irrigation and debridement.

Hegewald et al.⁹ observed a rate of 0.05 (0.00-0.13) for hardware removal among combined fixation patients in a retrospective case series that assessed the clinical and radiographic outcomes of diabetic Charcot reconstruction using combined internal and external fixation. A total of 22 patients were reviewed. Pin tract infections were reported in 10 patients (45.45%) 4 to 8 weeks postoperatively. Deep space infection developed in 3 patients (13.64%), 2 (66.67%) at the surgical site and 1 along a pin tract. All cases of deep infection required reoperation. Additionally, there was wound dehiscence in 8 patients (36.36%), 4 (50%) of which occurred at sites of wound excision and flap closure.

Pin tract infections

The rate of pin tract infections was calculated to be 0.261 (0.000-0.636) for combined fixation. DeVries et al.¹³ had a rate of 0.07 (0.00-0.26) and Hegewald et al.⁹ had a rate of 0.45 (0.25-0.66).

Wound dehiscence

The rate of wound dehiscence was calculated to be 0.216 (0.000-0.502) for combined fixation. DeVries et al.¹³ had a rate of 0.07 (0.00-0.26) and Hegewald et al.⁹ had a rate of 0.36 (0.16-0.56).

Deep infections

The rate of deep infections was calculated to be 0.113 (0.000-0.228) for combined fixation. DeVries et al.¹³ had a rate of 0.07 (0.00-0.26) and Hegewald et al.⁹ had a rate of 0.14 (0.00-0.28) for the combined fixation patients.

Discussion

Many studies report fusion and limb salvage rates as the primary surgical outcomes for Charcot foot deformity patients. Other outcomes, including hardware removal, hardware complications, wound dehiscence, deep infections, irrigation and debridement, and pin tract infection, were viewed as secondary. Hardware removal rate of 13.3% was noted in intramedullary nail patients, compared to 0.7% in external fixation patients and 5.0% in combined fixation patients. Intramedullary nail is a more invasive procedure for the bone, as the hardware is placed in the medullary cavity. In the event of error or infection, complete removal is usually required. In the context of external fixation, minor corrections may be possible, and complete hardware removal will likely occur less commonly than with intramedullary nail. Thus, external fixation may potentially provide a better alternative, with less risk of complete hardware removal than Intramedullary nails in certain patient populations, for which both might be appropriate.

A hardware complication rate of 18.2% was noted in intramedullary nail patients, compared to 0.7% in external fixation patients and 21.8% in combined fixation patients. Therefore, it may be more favorable for a patient with Charcot foot to undergo external fixation rather than internal or combined fixation to decrease the risk of hardware complications. However, this difference between techniques does not account for differences in patient presentation, thus warranting further study.

A deep infection rate of 3.1% was noted in intramedullary nail patients compared to 3.2% in external fixation patients and 11.3% in combined fixation patients. Similar rates are seen in intramedullary nailing and external fixation; thus, deep infections are likely not to be a determining factor when choosing between the 2 procedures. Combined fixation, however, carries a higher risk of deep infection, and use of either an intramedullary nail or external fixation may be a safer alternative. Again, however, we were unable to account for patient differences that might preferentially dispose clinicians to using combined fixation, while also predisposing to infection.

A wound dehiscence rate of 5.9% was noted in intramedullary nail patients, compared to 10.8% in external fixation patients and 21.6% in combined fixation patients. An irrigation and debridement rate of 13.5% was noted in intramedullary nail patients, compared to 0.7% in external fixation patients and 21.8% in combined fixation patients. As above, these differences may warrant further study.

A pin tract infection rate of 34% was noted in external fixation patients and 26.1% in combined fixation patients. Therefore, combined fixation may provide a better alternative in patients at risk for pin tract infections.

Given the differences observed in this review, there is a need for future studies that compare complications between all 3 types of surgeries for the management of Charcot foot: intramedullary nail fixation, external fixation, and combined fixation. None of the studies compared outcomes between all 3 surgical types, whether primary or secondary outcomes, or the more commonly studied fusion and limb salvage. Conducting a large clinical study on CN patients presents many challenges, not least of which is the relative rarity of the condition. Future studies, even if focusing only on single surgical methods, could also attempt to elucidate risk factors for the complications reviewed here.

Of note, this study only reports published results, which could come from more skilled surgeons with higher contributions to the literature and fewer complication rates. This may lead to a bias in our reported results. However, there was also a great deal of heterogeneity in the studies; this is evident in reading the results, but also manifested in high I2 values in the analysis of the intramedullary nail and combined outcomes, and pin tract and dehiscence for external fixator.

Conclusion

The ideal treatment for CN remains unclear. Our study was able to examine secondary outcomes of 3 surgical techniques. Based on secondary complications, each technique has its own limitations: minimal hardware removal or complication with external fixator and minimal wound dehiscence in intramedullary nail. We recommend that orthopaedic surgeons choose an optimal fixation based on the likeliest complication and clinical judgment. Our hope is that these findings can help build guidelines for orthopaedic surgeons to follow in choosing which surgical intervention is best for CN patients.

Footnotes

Acknowledgements

The authors thank Anne Howard and Julie Trumble, Library Liaisons, University of Texas Medical Branch Moody Medical Library, for their assistance with the literature review.

Declaration of Conflicting Interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Vinod Panchbhavi is a consultant for Stryker Orthopedics as well as an editor for Lippincott Williams and Wilkins Publishing. The other authors have nothing to disclose.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Ethical Approval

Not applicable, because this article does not contain any studies with human or animal subjects.

Informed Consent

Not applicable, because this article does not contain any studies with human or animal subjects.

Trial Registration

Not applicable, because this article does not contain any clinical trials.

ORCID iDs

Atish S. Amin

Vinod Panchbhavi

Daniel C. Jupiter

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