Are foot and ankle corticosteroid injections safe during the COVID-19 pandemic? A single center prospective observational study

Abstract

Background

Intra-articular corticosteroid injections (ICSI) are commonly used in orthopedic practice. Due to concerns about their immunosuppressive effects, we conducted a prospective observational audit, to monitor for COVID-19 infection amongst a group of foot and ankle patients who received an ICSI during the pandemic.

Patients and methods

Included were 68 patients (25 males - 43 females, mean age 59.1 years, SD 15.0, range 19 – 90 years) who received a fluoroscopy-guided ICSI within a two-month period during the pandemic. The American Society of Anaesthesiologists (ASA) grade was I in 35 % of patients, II in 58 % and III in 7 %. 16 % of patients had black, Asian or minority ethnic (BAME) background. The dose of methylprednisolone injected was 20 mg for 28 % of the patients, 40 mg for 29 % and 80 mg for 43 %.

Results

All patients were available for follow up at one and four weeks post-injection. None reported COVID-19 infection symptoms within this period. The only complication was a flare-up of joint pain.

Conclusion

Our study showed that the risk of COVID-19 infection to patients receiving foot or ankle ICSI is low. The limitations of this work must be considered, but our findings support the judicious use of corticosteroid injections during the current crisis

1. Introduction

Intra-articular corticosteroid injections (ICSI) are commonly used for the treatment of a range of musculoskeletal pathologies. They have a diagnostic, therapeutic, and prognostic role in the management of patients with musculoskeletal pain and are a widely recognized bridge to definitive orthopedic surgical treatment [1]. The systemic effects of ICSI may be significant, as studies have shown that they suppress the hypothalamic-pituitary-adrenal axis, potentially impairing the body’s response to stress 2, 3. There have been concerns that they may increase the risk of contracting COVID-19 infection [4], as an observational cohort study from the Mayo Clinic identified a relative risk of 1.52 (95 % CI, 1.20–1.93) contracting influenza infection following a single ICSI [5]. Further, there is also concern that mortality in patients contracting COVID may increase, as systemic steroids have been shown to increase mortality in patients with influenza pneumonia [6].

Systemic corticosteroids have also been found to impair the clearance of coronavirus RNA from the respiratory tract and blood 7, 8, increase the risk of requiring mechanical ventilation and renal replacement therapy in Middle East Respiratory Syndrome (MERS) [9] and are linked with complications such as diabetes mellitus and avascular necrosis in patients with Severe Acute Respiratory Syndrome (SARS) 10, 11.

At the onset of the COVID-19 pandemic, uncertainty about the safety of ICSI prompted publication of national guidelines discouraging their use 12, 13, 14. Reduced hospital capacity, as a result of COVID-19, has resulted in an ever-increasing number of patients waiting for interventional pain management. This has further compounded the issue of long waiting lists [15]. As cases of COVID-19 infections have risen again, a growing need for guidance on the safe resumption of intra-articular corticosteroid injections has emerged [16], but little evidence exists around the safety of ICSI in the context of the current COVID-19 pandemic [17]. Retrospective observational studies have found very low incidence of COVID-19 infection, or COVID-19 related adverse clinical outcomes, following corticosteroid injections [18]. There have therefore been attempts to revise national guidelines to reflect the emerging evidence [19]. This has led to guidance being published from the British Orthopedic Association (BOA) [20].

We were interested in determining if the administration of a foot or ankle ICSI during the COVID-19 pandemic is a safe practice. Our primary aim was to measure the COVID-19 incidence rate in this group of patients, and we hypothesized that this would not be raised. Our secondary aim was to monitor those patients for other complications following their injection. To document the above, we undertook a prospective case series study.

The management pathway adopted is akin to that described by the British Orthopedic Association. We therefore also aim to validate the safety of the current national guidance on intra-articular ICSI use during the COVID-19 pandemic.

2. Patients and methods

2.1. Study population

Data was collected prospectively from all foot and ankle patients undergoing fluoroscopy guided ICSI over a two-month period (17/07/2020–17/09/2020) at our institution. Data collection was undertaken as an audit, in line with our Trust Audit Policy and following approval from the Clinical Governance Committee, and all patients provided written informed consent. All patients who had a ICSI within this period were included consecutively, without exclusions. All procedures were performed in an operating theater setting, using a mini C-arm (Fluoroscan InSight, Hologic™, Marlborough, USA) for fluoroscopic guidance. Lignocaine 1 % was utilized for local anesthesia of the skin and 0.5–1 ml of contrast medium (Omnipaque, GE Healthcare, Marlborough, USA) was used to perform an arthrogram. Twenty to eighty milligrams of methylprednisolone mixed with bupivacaine 0.25 % w/v was used for the ICSI. The strength of methylprednisolone and the quantity of bupivacaine varied, depending on the joint injected and the surgeon’s preference.

2.2. Intervention

All foot and ankle patients who were listed for a corticosteroid injection between the first and second COVID-19 pandemic wave were contacted by their responsible consultant, and the need for performing the injection during this second wave of the pandemic was discussed. Fig. 1 demonstrates the sites of corticosteroid injections. Information was provided regarding the potential COVID-19 specific risks, and informed consent was obtained prior to re-listing them for ICSI. Fig. 2 demonstrates the pandemic-specific consent form which was developed and utilized within our institution. Patients were graded as low, medium, or high risk with regards to COVID-19, as per BOA guidance [21].

Fig. 1.

Site of corticosteroid injections performed from 17 July to 17 September 2020.

Fig. 2.

The consent form used in our institution for patients due to have an intra-articular corticosteroid injection during the COVID-19 pandemic.

Patients were then contacted with a proposed date for their injection and were advised about self-isolation prior to and after the procedure. A screening questionnaire was used to ensure that they had no symptoms suggestive of COVID-19. Patient pathway is summarized in Fig. 3. Patients underwent a SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) nose and throat swab test three days prior to their procedure. Those found to have a positive test were contacted and their procedure was canceled. The rest of them, on the day of their procedure, underwent temperature check and another screening questionnaire for COVID-19 symptoms on admission. The “green” (i.e., free of COVID-19 patients) site of the hospital, where these procedures were performed, operated a one-way flow system, as patients moved from reception to the admission and waiting area, to theaters and then to the recovery area. Patients were followed-up telephonically at one- and four-weeks post-injection.

Fig. 3.

Diagram demonstrating the patient’s pathway for foot and ankle corticosteroid injections during the COVID-19 pandemic.

3. Results

68 patients had a foot or ankle ICSI within the study period ( Table 1). Male to female ratio was 25:43. Mean age at time of ICSI was 59.1 years (SD 15.0, range 19–90 years). In terms of ethnicity, 57 patients (84 %) were white, 6 patients (9 %) were Asian, 4 patients (6 %) were classified as “Other” and 1 patient (1 %) was of mixed ethnicity. The American Society of Anesthesiologists (ASA) grade was I in 24 (35 %) patients, II in 39 (58 %) patients and III in 7 % of patients. Using our institution’s grading system, 20 (29 %) patients were graded as low risk, 22 (32 %) as moderate risk, and 26 (39 %) as high risk. Out of the 68 patients, 16 (24 %) had a background of respiratory disease, 15 (22 %) had chronic cardiovascular disease, 8 (12 %) had diabetic mellitus, 2 (3 %) had a malignancy that was in remission and 1 (1 %) had chronic kidney disease. Two patients (3 %) had 2 of the above comorbidities and 6 patients (9 %) had 3. Eleven patients (16 %) were classed as obese (BMI >35), 3 patients (4 %) were smokers and 9 patients (13 %) had other comorbidities.

Table 1.

Patient characteristics (N = 68).

Patient characteristic (N = 68)	Number of patients (n)	%
Male	25	37 %
Female	43	63 %
Age in years (mean ± SD)	59.1 ± 15.0
Current smoker	3	4 %
Ethnic background
White	57	84 %
Asian	6	9 %
Mixed	1	1 %
Other	4	6 %
ASA score
I	24	35 %
II	39	57 %
III	5	8 %
Risk
Low	20	29 %
Medium	22	32 %
High	26	39 %
Comorbidities
Respiratory disease	16	24 %
Chronic cardiovascular disease	15	22 %
Obesity	11	16 %
Diabetes	8	12 %
Malignancy in remission	2	3 %
Chronic kidney disease	1	1 %
Other	9	13 %

ASA: American Society of Anaesthesiologists

All patients were available for follow up at one week and four weeks post-injection. No one reported symptoms that would raise concerns regarding a COVID-19 infection within this period. One patient had a flare up of ankle joint pain the night following their injection and attended A&E but left without waiting to be examined. Their symptoms subsequently improved after one day.

4. Discussion

This prospective, single center case series study of 68 foot and ankle patients, who received fluoroscopy-guided ICSI within a two-month period during the COVID-19 pandemic, describes no incidence of COVID-19 infection in this cohort. In contrast, the FAlCoN audit demonstrated a 0.60 % percentage of COVID-19 infection in our hospital’s region, for foot and ankle patients who underwent trauma or elective surgery just before, during and after the first lockdown in the UK [22] Our findings suggest that, when used in conjunction with an appropriate pathway to minimize risk, intraarticular foot and ankle corticosteroid injections can be a safe treatment, even in high-risk patients.

The onset of the pandemic was sudden and spread at an alarming rate. Very little was known about the potential risks that could arise from corticosteroid-mediated immunosuppression, and guidance against corticosteroid injections in the early months of the pandemic was perhaps justified. Since then, our knowledge of COVID-19 has expanded greatly, but there is still an absence of reliable evidence from large-scale randomized clinical trials on local corticosteroid therapy in the context of COVID-19. Preliminary results of the RECOVERY trial using systemic corticosteroids showed a significantly reduced 28-day mortality rate in patients who received a dose of 6 mg of dexamethasone daily for up to 10 days, compared to those who received usual care [23]. The incidence of death was also lower in patients who required invasive mechanical ventilation and were treated with dexamethasone, than in those treated with usual care, even after being adjusted for age. However, these patients received systemic corticosteroid therapy rather than a local corticosteroid injection, therefore these results should be interpreted with caution.

Similar to our findings, a previous retrospective observational study of 443 patients, who received image-guided steroid injections between 1 February and 30 June 2020, described a low incidence of symptomatic COVID-19 in this cohort [18]. Nine of those patients (2 %) went on to receive a SARS-CoV-2 RT-PCR test, all of which were negative. Similarly, Chang et al. conducted a prospective study of 71 patients in Massachusetts, who underwent image-guided corticosteroid injections between 15 April and 22 May 2020 [24]. Of the 66 patients available for follow-up, only 1 patient (1.52 %, [95 % CI, 0.04–8.2 %]) developed a symptomatic COVID-19 infection. The prevalence of COVID-19 cases in Massachusetts at the time of the study was 0.91 %, therefore no significant difference was identified between the rate of new COVID-19 infection cases in the study cohort and the general population.

One limitation of our study is that the true COVID-19 status of the patients was unknown. It is estimated that up to 87.9 % of COVID-19 infected individuals could be asymptomatic [25] and, at the time of the study, mass testing of the population was not in place. RT-PCR testing was carried out on all patients prior to their procedure, and no patient was given a corticosteroid injection if they tested positive for COVID-19.

Our study is one of the earliest prospective study during the pandemic which, demonstrated that the risk of COVID-19 infection to patients who receive intra-articular corticosteroid injections can be minimized by implementing a carefully designed pathway [14]. Appropriate information must be accompanied by a specifically designed consent form, which should be produced at the center where the surgery is to be performed [26].

Clinical pathways ensure a coordinated and efficient protocol for care, ultimately helping to provide safe provision of care and improve patient outcomes [27]. The results of our study support the introduction of similar treatment pathways, as part of the safe resumption of intraarticular corticosteroid injections.

In conclusion, our prospective study showed that the risk of COVID-19 infection to patients receiving foot and ankle fluoroscopy-guided intraarticular corticosteroid injections is low. As the incidence of COVID-19 cases has increased again, our findings support both the advocacy for judicious use of corticosteroid injections during the current crisis and the recommendation for the implementation of treatment pathways to minimize risk of COVID-19 adverse outcomes, especially as higher risk treatment options continue to be limited.

Conflict of interest

All authors declare that they have no conflicts of interest.