Orbital Fractures Treated in a University Hospital of Southern Italy: Epidemiology, Outcomes and Prognostic Factors Resulting From 538 Retrospectively Analyzed Cases.

doi:10.21203/rs.3.rs-3117168/v1

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Orbital Fractures Treated in a University Hospital of Southern Italy: Epidemiology, Outcomes and Prognostic Factors Resulting From 538 Retrospectively Analyzed Cases.

https://doi.org/10.21203/rs.3.rs-3117168/v1

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published 01 Apr, 2024

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Purpose: Orbital fractures are common injuries and represent an interesting chapter in maxillofacial surgery. This retrospective study analyses data collected from 528 patients surgically treated at the University Hospital "Magna Graecia", Catanzaro, Italy, from 1^st January 2007 to 31^st January 2021.

Methods: The inclusion criteria were diagnosis of orbital bone fracture, complete clinical and radiological records, and a minimum follow-up of 12 months. Gender, age, aetiology, fracture type, treatment, surgery timing, and associated complications were analysed.

Results: The most frequent cause of trauma was road accidents (37.88%), followed by domestic accidents (25.95%). The manifestation of diplopia (72.35%), infraorbital nerve hypoesthesia (53.41%), extrinsic eye movement limitation (51.70%), and enophthalmos (41.29%), determined the indication for surgery. The sub-eyelid approach was preferred (79.36%). The study shows a statistical significance in the correlation between the severity of the herniation of the lower rectus muscle and the presence of preoperative diplopia (p-value = 0.00416); the same statistical significance has been found for the post-postoperative diplopia (p-value = 0.00385). Patients treated after two weeks after the trauma show a higher rate of diplopia and a greater limitation of long-term post-operative eye movements than those treated within two weeks (diplopia 23.08% vs. 15.56%; eye movements limitation 13.33% vs. 7.69%). Early surgical treatment (>14 days) appears to reduce the likelihood of functional and structural damage to the lower rectus muscle.

Conclusion: Our data will support future maxillofacial traumatology studies and the education and prevention measures taken will reduce the incidence of orbital trauma.

Orbital Fractures

Maxillofacial surgery

Epidemiology

Traumatology

Outcomes and prognostic factors

Orbital fractures (OF) have an incidence of 40–70% of all facial bone fractures and the orbital floor is the most involved as it represents the thinnest wall [1–6]. They are more common in males between 21–30 years [2, 7]. The most common aetiology is road accidents and accidental falls [7–11]. According to Cramer et al classification, we distinguish OF into pure (confined to orbital walls) and impure (involving adjacent bones) [1–6]. Often associated signs and symptoms are diplopia, eye movement limitation (entrapment of the inferior rectus muscle), hypo-anaesthesia (infraorbital nerve involvement), and enophthalmos. To date, surgical timing is still controversial; the literature suggests surgery within two weeks in case of ocular and/or nervous involvement or increased orbital volume (as in the case of retrobulbar hematoma with progressive loss of visual acuity). The main objective of the surgery is to restore the continuity of the bone walls to reestablish the orbital volume; the reconstructive approaches used are various. This study aims to retrospectively analyse the orbital fractures surgically treated at the University Hospital “Magna Graecia” Department of Maxillofacial Surgery, one of the largest reference Centers for maxillofacial traumatology in southern Italy. We focused on the associations between age, sex, aetiology, fracture location and surgical timing, and the collected data showed that late surgery and pre-operative inferior rectus herniation are negative prognostic factors for the permanence of diplopia and enophthalmos in the long-term follow-up.

This retrospective study includes patients with OF surgically treated at the Maxillofacial Traumatology Center of the "Magna Grecia" University Hospital of Catanzaro, from January 1^st, 2007, to January 31^st, 2021. The study was carried out according to the guidelines set out in the Helsinki Declaration and was approved by the Ethics Committee of the "Magna Grecia" University. Age, sex, fracture aetiology, pattern and severity of the fracture, symptoms, comorbidity, timing of surgery, surgical approach, reconstruction materials, and short-term and long-term complications were collected.

2.1 Inclusion and Exclusion Criteria

The inclusion and exclusion criteria of the study are summarized in Table 1.

Table 1: Inclusion and exclusion criteria of the study.

*Inclusion Criteria*	*Exclusion Criteria*
Diagnosis of pure/impure orbital fracture.	History of surgery for orbital floor fractures.
Patients with complete clinical and/or radiological documentation.	Prior eye surgery.
12-month follow-up.	Non-cooperative patients.

2.2 Procedure

All patients arrived, hemodynamically stable, from the Emergency Departments of other local Hospitals with radiological exams and urgent specialist visits. After clinical and radiological consultation, patients were hospitalized in case of surgical indication. During the Covid-19 period (2020-2021-2022 years) patients were screened by nasopharyngeal swab for SARS-CoV-2. Moreover, before hospital admission, a second triage (questioning about symptoms, and contacts with COVID-19-positive people) and a second nasopharyngeal swab were performed (patients were placed in isolation pending the swab result). Each patient underwent:

An experienced team collected medical records and carried out a careful objective examination. The patient underwent a comprehensive physical examination, including weight, height, and vital signs. They were also classified according to the Harris classification.
Thin layer CT (1 mm) with axial, coronal, sagittal acquisitions and 3D reconstructions. The severity of the fracture was assessed on the following radiological parameters: (1) herniation of the orbital fat into the maxillary sinus below; (2) herniation of the lower rectus muscle into the maxillary sinus below; (3) involvement of the infraorbital canal in the fracture rhyme; (4) involvement in the CT coronal projections of the lateral wall, medial wall, or entire orbital floor; (5) participation in the CT sagittal projections of the lateral wall, medial wall, or entire orbital floor. The main orbital floor fracture sites were classified into both sagittal and coronal planes in three portions: medial, lateral, or complete on the sagittal plane; anterior, posterior, or complete on the coronal plane.
Specialist evaluations (ophthalmologist, orthoptist, and neurosurgeon in case of neurocranial involvement), Hess-Lancaster screens, and Hertel exophthalometry (in case of clinically evident enophthalmos).

All patients were treated under general anaesthesia. Two types of transcutaneous surgical access were used, subciliar or sub-eyelid. Four different materials were used for the reconstruction of the orbital floor: (1) intraoperative bending of titanium mesh; (2) preformed titanium mesh; (3) absorbable membrane (Tutopatch®, the connective tissue of pure collagen preserved and dehydrated with organic solvents according to the patented process of preservation and sterilization Tutoplast®); (4) Patient-specific titanium mesh, modelled before surgery on a stereolithographic model obtained by 3D printing patient’s CT. Based on the time between trauma and surgery, patients were divided into two groups:

Group A: early treatment, surgery performed within 2 weeks from the trauma.
Group B: late treatment, surgery performed 2 weeks after trauma. This group includes inveterate OF.

From this retrospective analysis, it emerged that the two groups were fairly homogeneous according to the demographic characteristics of the patients treated surgically (age, sex, type of injury etc.).

2.3 Follow-up

All patients underwent both clinical and instrumental follow-ups for one year. Clinical checks were thus carried out:

About 1 week after surgery: clinical check and removal of sutures (usually endodermal suture).
After 15 days: clinical check.
After 30 days: clinical check.
After 3 months: clinical check and CT.
After 6 months: clinical check, orthoptic evaluation, and execution of both Hess- Lancaster screens and Hertel exophthalometry (only in case of persistence of enophthalmos). Other possible orthoptic revaluation only in case of specific indication by the specialist.

At each clinical check, we evaluated the epicritic tactile sensitivity of the innervation region of the second branch of the trigeminal nerve (smear and/or pinch test and subjective evaluation questionnaire), extrinsic eye motility, the presence of diplopia and/or enophthalmos, and the presence of post-surgical complications. Post-surgical complications were evaluated in the short term, within 15 days of surgery, and at a distance, more than 3 months after surgery. The presence of infection, hematoma, palpebral retraction, ectropion, scars, and ptosis was investigated.

In addition, postoperative CTs were prescribed after 3 months and 1 year from surgery in axial, coronal, and sagittal projections; 3D reconstructions were made.

2.4 Statistical Analysis

Both descriptive and regressive statistical analyses were performed on the recorded data.

Descriptive statistical analysis was performed using central tendency indices (such as mean and range) and absolute and relative frequencies for categorical data. Regressive statistical analysis was performed using the student’s t-test, calculated using the GraphPad program (GraphPad Company, San Diego, CA, USA).

In the timeframe analysed, 1227 patients were evaluated for orbital trauma and only 528 fulfilled the study’s inclusion criteria. The sample examined included 352 males (66.67%) and 176 females (33.33%), with an average age of 41.5 years and a range of 13-88 years. The most frequent cause of trauma was road accident (n.200, 37.88%), followed by domestic accidents (n.137, 25.95%), interpersonal violence (n.91, 17.23%), sports injuries (n.55, 10.42%) and work accidents (n.18, 3.41%). In a few cases, it was not possible to trace the aetiology of the trauma (27 cases, 5.11%). Analyzing the correlation between gender and the mechanism of injury, road accidents were the most common cause of fracture in men (n.116, 32.95%), while domestic accidents were in women (n.80, 45.45%). The other mechanisms of injury based on gender are specified in Image 1.

In most cases patients presented pure orbital fractures, in 401 cases (75.95%); only in 127 cases (24.05%) patients presented impure orbital fractures. Of all pure orbital fractures (401 cases, 75.95%), 276 patients were affected by pure blow-out fractures (68.83%), 114 patients were affected by both blow-out and medial orbit wall fractures (28.68%), and 11 patients were affected by trap-door fractures (2.74%). Of all impure orbital fractures (127 cases, 24.05%), 18 cases (13.79%) were associated with Orbito-Maxillo-Zygomatic (OMZ) complex fractures and 11 cases (8.62%) were associated with the pan facial fracas. Data relating to the type of orbital fractures are summarized in Table 2.

Table 2: Orbital fracture pattern

*Pure Orbital Fractures*			*Impure Orbital Fractures*
Blow-out Fractures	Fractures of the floor and medial wall of the orbit	Trap-door Fractures	Orbital Fractures + OMZ complex fractures	Orbital Fractures in Pan Facial Fracas
276 patients (69.83%)	114 patients (28.68%)	11 patients (2.74%)	78 patients (61.42%)	49 patients (38.58%)
214 (%): Moderate grade according to Harris classification 176 (%): Severe grade according to Harris classification
401 patients			127 patients

The main signs and symptoms at diagnosis were periorbital oedema (n.464, 87.88%), diplopia (n.382, 72.35%), enophthalmos (n.218, 41.29%), hypoaesthesia of the infraorbital nerve (n.282, 53.41%), extrinsic eye movement limitation (n.273, 51.70%). The presence of diplopia, enophthalmos, hypoaesthesia, and/or extrinsic eye movement limitation determined the indication for surgical treatment. Considering the CT morphologic parameters, the anterior-medial portion of the orbital floor was the most affected, followed by the posterior-lateral portion.

On the coronal sections, the medial portion of the orbital floor was the most affected (144 cases, 52%), followed by the lateral portion (99 cases, 36%) and the whole floor (33 cases, 12%).

On the sagittal sections, the anterior portion of the orbital floor was the most affected (182 cases, 66%), followed by the rear portion (66 cases, 24%) and the whole floor (28 cases, 10%).

Considering the severity of the orbital floor fracture: 509 patients (96.55%) presented herniation of orbital fat into the below maxillary sinus, 273 patients (51.72%) presented herniation of the lower rectus muscle into the below maxillary sinus below, 237 patients (44.83%) presented an involvement of the infraorbital canal by the fracture rhyme, and 18 patients (3.45%) presented a lower rectus muscle entrapment.

Regarding the surgical approach, sub-ciliary access is the most employed (419 cases, 79.36%), followed by sub-eyelid access (109 cases, 20.64%). Thirty-six patients operated through sub-ciliary access (8.59%) have reported retraction of the lower eyelid while none of the patients operated through sub-eyelid access has gone through this type of complication. The orbital wall was reconstructed using different implants (Image 2), including intraoperative bending of titanium mesh (n.291 55.11%), preformed titanium mesh (n.164, 31.06%), patient-specific titanium mesh (n.38, 7.20%), absorbable membrane type Tutopatch® (n.34, 6.63%).

Postoperative complications occurred mainly in impure blow-out fractures (where the orbit's floor and medial wall are associated). In the first two weeks after surgery, a low degree of resolution of short-term diplopia was found, regardless of the severity of the fracture pattern. Two weeks after surgery, 124 patients with pure blow-out fractures (44.93%) had diplopia, and 39 patients with impure blow-out fractures (34.21%). Three months after surgery, diplopia was persistent in 52 patients with pure blow-out fractures (18.84%) and 24 patients with impure blow-out fractures (21.05%). This reversal has increased over time, in fact,6 months after surgery, long-term postoperative diplopia was recorded in 36 patients with pure blow-out fractures (13.04%) and 18 patients with impure blow-out fractures (15.79%).

Data on pre-operative and post-operative diplopia are explained in Table 3.

Table 3: Pre- and post-operative diplopia depending on the type of Blow-out fractures.

Preoperative entrapment of the lower rectus muscle

Preoperative Diplopia

Postoperative Diplopia: 2 weeks after surgery

Postoperative Diplopia:

3 months after surgery

Postoperative Diplopia:

6 months after surgery

Pure Blow-out

249

290

124

Impure Blow-out

A statistically significant correlation was found between the amount of lower rectus muscle herniation, visible at CT scans, and the presence of pre-operative (p-value = 0.00416) and postoperative (p-value = 0.00385) diplopia. Moreover, in the impure blow-out fractures, a statistically significant correlation has been observed between the presence of short-term diplopia and its long-term persistence (p-value = 0.00513).

Long-term postoperative enophthalmos was recorded in 9 patients (3.23%) with isolated blow-out fractures and 18 (15.38%) with concurrent floor and medial wall orbit fractures.

Other long-term postoperative complications were less frequently detected: eyelid retraction (n.5; 8.62%), ectropion (n.2; 3.45%), lagophthalmos (n.2; 3.45%), ptosis (n.1; 1.72%), exophthalmos (n.1; 1.72%). Postoperative diplopia, restriction of extrinsic long-term eye movements, hypoesthesia and enophthalmos were also evaluated about the timing of the surgery. These data are shown in Table 4.

Table 4: Post-operative complications of surgical timing.

*Timing of surgery*	*Group A: Patients treated within 15 days* *409 (77.46 %)*	*Group B: Patients treated after 15 days* *119 (22.54%)*
Diplopia	63 patients (15.40 %)	27 patients (22.68 %)
Extrinsic eye movements limitation	31 patients (7.58 %)	16 patients (13.20 %)
Hypoesthesia	99 patients (24.20 %)	27 patients (22.69 %)
Enophthalmos	54 patients (13.20 %)	9 patients (7.56 %)
*Total*	247 patients (60.39 %)	79 patients (66.39 %)

In the literature, there are many studies on the epidemiological characteristics of OF: clinical, surgical approach, timing etc. There are, however, very different opinions, with controversial operational indications that vary between professionals [12–15]. The incidence of OF is constantly increasing, with an incidence range of up to 70%, especially isolated/pure blow-out fractures. This figure is linked to the increase in road accidents, assaults, and domestic accidents, as attested also by our epidemiological study that attests a clear prevalence of road accidents (37.88%); although the mandatory use of appropriate personal protective equipment has proved effective in reducing the severity of facial injuries [16]. These data are related to two important considerations: our department is the only reference Centre for maxillofacial traumatology; Calabria is a region that hosts thousands of tourists a year, as shown by the monitoring of traffic flows on the road network (mountain tourism, both summer and winter and seaside tourism). However, in 2019–2020 there was a reversal of the etiological trend with 31.8% of trauma due to aggression compared to 6% recorded in previous years. During the 2020 lockdown, most traumas occurred in a domestic environment (75% in 2020 vs. 23.33% in 2019), particularly interpersonal violence in women (31.58% in 2020 vs. 14.28% in 2019) [17]. This reversal of the etiological trend was also highlighted in the Campania and Umbria regions [18–19]. Regarding the aggressions, were involved in a percentage above all the foreigners, surely due to an increase in the clandestine landings.

The primary objective of surgery is to remedy functional and aesthetic damage. This is done by restoring normal orbital volume: repositioning soft tissues and freeing imprisoned muscles. However, surgery is not always indicated. In the present study, only patients with a medium to high grade according to the Harris classification [20] were treated: patients with moderate and/or severe orbital floor breakdown; patients with functional and/or sensorineural deficits (restriction of eye movements, diplopia, enophthalmos, infraorbital nerve hypoesthesia, etc.).

Examining the fracture pattern, pure blow-outs represent the predominant pattern (401 cases): 69.83% of pure fractures and 52.27% of all fractures). When impure, blowouts are more often associated with OMZ complex fractures (14.77%). Regarding the fracture site, greater involvement of the anterior-medial portion was found (34.48%) which is associated with an increased risk of herniation of the orbital structures, especially the lower rectus muscle. The present study shows that there is statistical significance in the correlation between the severity of the lower rectus muscle herniation and the presence of pre-operative (p-value = 0.00416) and post-postoperative (p-value = 0.00385) diplopia. Thus, muscle herniation can be considered a negative prognostic factor for the recovery of diplopia. Our study supports the evidence of Ordon et al. [21] that the presence of diplopia by muscle herniation indicates surgery, regardless of the degree of herniation. There are, however, confounding factors such as the presence of oedema and haematomas of peri-orbital tissues (in our study present in 464 patients; 87.88%). They could mask or accentuate diplopia in case of minor breakdowns of OF. For this reason, in our experience, we tend to wait at least 5–7 days before surgery. Regarding the surgical approach: 419 patients were treated with the sub-ciliary approach (79.36%), and 109 patients were treated with the sub-palpebral approach (20.64%). The first caused more complications than the second. Thirty-six patients operated through sub-ciliary access (8.59%) reported the retraction of the lower eyelid while none of the patients operated through sub-eyelid access suffered this type of complication. The choice of reconstruction material is dictated by the type of fracture: in the most severe cases were used non-resorbable material, was precisely intraoperative bending of titanium mesh (291 patients, 55.11%), preformed titanium mesh (164 patients, 31.06%), and patient-specific titanium mesh shaped on 3D printed (38 patients, 7.20%). These materials allow for an optimal aesthetic and functional result if correctly positioned. By comparing the use of various non-absorbable materials, our study found no statistically significant difference in long-term complications such as diplopia and enophthalmos. The same result was proposed by Strong et al [22]. The long-term complications related to the timing of the surgery have shown different results depending on the symptom considered. Considering long-term post-operative enophthalmos (after 3 months from surgery), patients treated after 2 weeks showed a lower rate than those treated within two weeks (7,56% vs. 13,20%). This figure is related to the reabsorption of oedema of periorbital soft tissues. Dal Canto et al, in a similar study, demonstrated how effective repair (with optimal functional and aesthetic recovery) can be achieved up to 29 days from trauma [23]. Other studies show how the early treatment of orbital fractures is associated with better results (both at functional and aesthetic levels) at a distance [13, 24–26]. Dal Canto et al also highlight how a conservative approach in the first 15 days can help prevent unnecessary surgery when oedema resolution does not show changes in visual function. Considering long-term post-operative diplopia and eye movements: patients treated two weeks after trauma have a higher rate of diplopia and limitation of eye movements than those treated within two weeks (respectively, diplopia 22.68% vs. 15.40%, and eye movements limitation 13.44% vs. 7.58%). These figures are consistent with the evidence of Prior et al [27–28]. Early surgical treatment appears to reduce the likelihood of functional and structural damage to the lower rectus muscle [20, 23].

Fractures with orbital material herniation should be treated within 1–3 days after the trauma. Unfortunately, operating within this timeframe is not always logistically possible. However, you should not wait more than two weeks. In addition, in impure blow-out fractures, a statistically significant correlation was observed between the presence of short-term diplopia (immediately after surgery) and long-term diplopia (3 months after surgery), with a p-value of 0,00385. So, postoperative diplopia is a negative prognostic factor for long-term diplopia.

Displaced fractures of the orbital walls when associated with other fractures of the maxillofacial area, require more complex surgical treatment and are often subject to the persistence of clinical-functional deficits in the long term (diplopia and enophthalmos).

OF surgery involves the restoration of normal anatomy and orbital volume, avoiding aesthetic and functional damage, and is still much debated in the literature (approach, material used and surgery timing). Their epidemiology varies widely between populations due to socioeconomic differences, laws, and individual behaviour. Determining the specific etiopathogenesis of such traumas is important for devising prevention and treatment strategies. The proposed study highlighted the role of herniation of the lower rectus muscle as an important negative prognostic factor for long-term diplopia recovery. Long-term complications related to the timing of surgery have shown different results depending on the symptom considered: diplopia and limitation of eye movements have a higher rate in patients treated after two weeks of trauma; enophthalmos has a higher rate in patients treated within two weeks of trauma. Descriptive research such as that proposed by us is therefore fundamental. Our data can be considered reliable, as they come from one of the major reference centres for maxillofacial trauma in southern Italy.

Funding: This research received no external funding.

Institutional Review Board Statement: The study was conducted following the Declaration of Helsinki. The Magna Graecia University of Catanzaro, Italy's Ethics Committee approved the study (protocol number 003589_15).

Informed Consent Statement: Informed consent was obtained from all subjects involved in the study. Subjects gave their consent to the publication of clinical photos.

Data Availability Statement: The data presented in this study are available upon request from the corresponding author.

Conflicts of Interest: The authors declare that they have no conflict of interest.

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No competing interests reported.

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Reviews received at journal
29 Aug, 2023
Reviewers agreed at journal
29 Aug, 2023
Reviewers invited by journal
29 Aug, 2023
Editor assigned by journal
30 Jun, 2023
Submission checks completed at journal
30 Jun, 2023
First submitted to journal
27 Jun, 2023

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Orbital Fractures Treated in a University Hospital of Southern Italy: Epidemiology, Outcomes and Prognostic Factors Resulting From 538 Retrospectively Analyzed Cases.

Status:

Journal Publication

Version 1

Abstract

Figures

1. INTRODUCTION

2. MATERIALS AND METHODS

3. RESULTS

4. DISCUSSION

5. CONCLUSION

Declarations

References

Additional Declarations

Status:

Journal Publication

Version 1