MATERIALS AND METHODS
Ethics
Patient reports from
the electronic hospital database over a 3-year period (2019 - 2021) were
analyzed. This study was registered by the Institutional ethics committee,
Royal Medical Services (IRB: 15/9/2022) on the 18th of October, 2022. As this
study was a retrospective analysis, the requirement for patient consent was
waived. Patients’ records and data processing has been accomplished according
to the Declaration of Helsinki (2013) and the Health Insurance Portability and
Accountability (HIPAA) actions.
Patients
As the protocol of
management in our Centre, all patients were initially evaluated clinically,
followed by radiological evaluation, after which a trial of conservative
treatment is given, in absence of sensorimotor deficits or intractable
radiculopathy. In these cases, included in our study, surgical decision based
on clinical and radiological evaluations was made. All patient data were
documented, including the extensive comprehensive history including demographic
features (age, gender, body mass index [BMI]), co-morbidities and the clinical picture. A
meticulous neurological evaluation and examination was then performed. Several
confirmatory investigations were performed: magnetic resonance imaging (MRI),
computed tomographic scan, dynamic x-ray, to confirm the diagnosis and exclude
secondary causes leading to neck and arm pain (Fig. 1).
Figure. I: Shows the pre-operative
radiological evaluation for patients presented with signs and symptoms of
cervical disc disease. A) X-rays (antero-posterior & dynamic, B) Ct scan
(sagittal & axial), C) MRI scan (sagittal and axial).
Study Design
This retrospective
chart analysis was conducted by revising all consecutive patients and their
medical files for whom intervention for treating
cervical disc herniation was conducted.
Inclusion/exclusion criteria
Inclusion criteria:
- Adult age > 18
years.
- One or more
cervical disc herniation.
- A minimum
follow-up period of 3- months.
Exclusion criteria:
- Oncology cases
scheme.
- Age < 18 years
- Patients with
spinal infection.
- Lack of
radiological evaluation, or clinical data.
- Previous cervical
spine surgery.
- Ossification of
posterior longitudinal ligament.
- Patients with
posterior instrumentation.
Surgical technique
The microsurgical
procedure of ACDF is a surgery to remove a herniated or degenerative disc in
the neck. Procedure was performed in a standardized manner following certain
surgical steps. Patient under general endotracheal anesthesia was placed in
supine position, and the damaged level was marked with X-ray control. The
region was prepped with alcohol, betadine scrub, and betadine paint prior to
incision and draped in a sterile fashion in all patients. The skin incision is
one to two inches on right hand side of the neck. The incision is made
horizontally within a natural skin crease, although occasionally a more
vertical incision is used for multilevel cases. The platysma is then split in
line with the skin incision, and the plane between the sternocleidomastoid
muscle and the strap muscles is then entered. Next, a plane between the
trachea/esophagus and the carotid sheath is entered. The pre-vertebral fascia
is then dissected away from the disc space. Fluoroscopy was then used to
reconfirm the level. After the correct disc space has been identified, the disc
is then removed by first cutting the outer annulus fibrosis and removing the
nucleus pulposus.
With an anterior
cervical discectomy, the entire disc is removed. The cartilage endplates on the
vertebral bones are also removed to reveal the hard cortical bone underneath. Dissection is conducted
from the front to back of the posterior longitudinal ligament, then the
ligament is gently removed to allow access to the spinal canal to remove any
disc material that may have extruded through the ligament, which may be
contributing to spinal stenosis. The uncinate processes partially removed as
well. Cervical fusion is done following the cervical discectomy. The insertion
of a cage into the evacuated disc space prevents disc space collapse and
promotes a growing together of the two vertebrae into a single unit. Plate is
used for all patients with three levels and more ACDF and some of patients with
2- levels, attached with screws into each of the vertebral bones. An operating
microscope was used in all the cases.
Statistical analysis
Data were registered
into the Microsoft Excel sheet, and analysis was performed using statistical
software SPSS Statistics Version 28.0. The categorical data were demonstrated
in frequency and percentages, while the scale data were stated employing
illustrative statistics such as mean and standard deviation for continuous
variables. An Independent sample t-test was used to evaluate mean differences
between scale data. Moreover, the chi-square test was used for the association
between categorical data, a binomial test was used to assess sample proportion
with hypothetical proportion, Alpha level set at 0.05 deemed statistically
significant.
RESULTS
This study was
conducted at KHMC and included 165 patients who had been diagnosed initially
with degenerative disc disease and admitted for ACDF. Patients were included if
they met the established diagnostic criteria for CDD. Of those, four patients
were disqualified due to additional posterior
instrumentation, six patients underwent corpectomy,
and three patients were eliminated due to incomplete data. The final study
group therefore contained 152 patients to be considered for the final analysis,
with 193 cervical levels operated (Fig. II). Of the final cohort, 57.24% of the
patients were males (87/152), with a mean age at diagnosis of 45.31 ± 10.89 years (range 25–69
years). The females had a mean age at diagnosis of 48.67 ± 9.93 years (range 23–73
years) as shown in Table 1. Statistical analysis of
the data revealed significant differences in terms of the number of levels
operated between the two groups and the peak age. On the other hand, our study had
several complications; our overall morbidity rate was 16.58% (P = 0194).
Figure. II: Study flowchart
Table 1 Demographic
and surgery data of the patients.
p value
|
Female group
|
Male
group
|
Parameters
|
0.074
|
65
|
87
|
Number of cases
|
0.001*
|
81
|
112
|
Number of levels
|
0.053
|
48.67±9.93
|
45.31± 10.89
|
Age (years)
|
0.643
|
28.6 ± 5.9
|
29.0 ± 4.7
|
Body mass index (kg/m2)
|
0.749
|
32.30%
|
29.88%
|
Diabetes
|
0.655
|
27.69%
|
31.03%
|
Smoker
|
0.002*
|
40-49
|
30-39
|
Peak age group
|
0.580
|
126 ± 77
|
119 ± 73
|
Surgery duration (min)
|
0.033
|
146 ± 105
|
198 ± 172
|
Blood loss (ml)
|
0.311
|
2.4 ± 0.6
|
2.3 ± 0.6
|
Duration of drainage (days)
|
0.980
|
1.276 ± 0.43
|
1.278
± 0.51
|
Number of levels operated
|
0.006*
|
15.14±4.6
|
13.44±2.88
|
Mean
follow up (months)
|
DISCUSSION
CDD is a universal
disabling medical condition in modern society and the estimated
prevalence reaches 95% by the age of 65 years (11, 12). Patients with cervical disc degeneration commonly
present with neck pain, radiculopathy resulting from nerve root compression,
which is mainly attributed to degeneration from natural aging, trauma, or occupational
hazards (13). Degenerative CDD is
most frequently reported in the age group between 35 and 55 years, and the
estimated incidence is around 5.5 patients per 100,000 of the population; it
leads to a surgical intervention in 26% of these individuals (14, 15). According to many publications, females are
less susceptible to developing this condition (16-23), while a higher incidence
of spondylotic changes in the population are correlated with increasing age and
with gender (17). In national studies of the Indian population, the main risk
factors that precipitate for cervical spondylosis are age and gender (19, 20).
In our review, 87 of our patients were male, a slight predominance; the
male-to-female ratio was 1.34 : 1. In the male group, predominantly the
patients were in the age group of 30–39 years (36.8%) followed by the age group
40–49 years (28.7%), while in the female group in most instances the patients
were in the age group 40–49 years (44.6%), followed by the age group 50–59
years (27.7%) (Fig. III). The most reported cervical disc herniation
levels are C4/5, followed by C5/6, and lastly C6/7 (24). Nevertheless, our
results showed that almost half of the study population (49.74%) presented with
degenerative disc disease at the C5–C6 disc level, followed by C6–C7 level
(22.79%) (Fig. IV).
Figure. III: Shows the age distribution between the two
groups
Figure. IV: Shows the cervical disc distribution between the two groups.
Clinical presentation
in patients with CDD is still ambiguous. Although neck pain is the cardinal
symptom, its source is still a matter of debate and uncertainty (25, 26). Discogenic pain is also another issue that has no
clear definition and evidence to provoke neck pain, although in most cases of
cervical disc herniation there is associated neck pain
(27-30). In our review, a tingling sensation was the cardinal symptom,
followed by neck pain, while sphincteric dysfunction was the least reported complaint
reported by our patients (Fig. V).
Figure. V: Shows the clinical presentation among the two groups.
In the diagnosis of
degenerative disc disease, there is a correlation between the clinical picture
and radiological imaging.
In our
day-to-day practice it might be challenging to discriminate between the pain
resulting from joint and muscle (mechanical pain) and cervical radicular pain,
but differentiation between the two entities is of great value. For cases of
cervical radiculopathy, established guidelines recommend earlier neurosurgical
referral, imaging study, and the use of neuropathic medications (31). Crucial
tools are a dedicated musculoskeletal examination and neurological evaluation
to distinguish between referred pain, radicular pain, and myelopathy.
Supplementary shoulder joint evaluation will help to rule out a principal
shoulder problem (32). Patients presenting
with radicular symptoms, upper limb myotomes, and dermatomes should be examined
(33). In our practice, we apply these guidelines. If the clinical presentation
is suggestive of persistent cervical radicular pain for a period of more than 4
to 6 weeks, imaging evaluation should be ordered (31).
Imaging modalities of
the cervical segment of the spine have dramatically evolved in the last
decades, especially with the development of technologies, and play an essential
role in the process of identification and lateralization of cervical radicular
pain. The primary examination that is normally done is a plain X-ray.
Antero-posterior and lateral exposures are beneficial for gaining an idea about
the global alignment of the cervical spine including the existence of any
recognizable spondylotic alterations of the facet joints. Lateral dynamic
(flexion and extension) exposures are effective to analyze any instability that
might not be identifiable on a static radiographic image. A thin slice computed
tomography (CT) scan providing high-resolution sagittal and coronal reformats
allows for a comprehensive assessment of the vertebral column degenerative
process. A CT scan is used to detect bone details in terms of bony lesions,
abnormal bone formation, or any osteophyte development in addition to any
deceptive process that may cause nerve root impingement (Fig. VI). MRI has become the procedure of choice for evaluation
of the spinal cord and surrounding soft tissues when a reliable neurologic
examination cannot be performed, or further evaluation is needed (34). MRI has
the highest capability to demonstrate the detailed soft tissue configurations
besides the nerve root course from cord to its exit from the foramen (35).
Electrophysiologic testing is an additional diagnostic tool that can be
utilized to assist in diagnosis of radicular pain (36).
Figure. VI: A
CT scan evaluation (sagittal and axial cuts) of C5/C6 degenerative cervical
disc disease, shows osteophyte formation
Once the diagnosis is
established and in the absence of sensorimotor deficit, physiotherapy for 6
weeks is recommended, although the mechanism of pain reduction is still unclear. Non-operative
management will improve pain in 75%–90% of patients presented and diagnosed
with cervical radicular pain (37, 38). Thus, physiotherapy substantially
reduces neck and arm pain, its cardinal aim being to reestablish neck
musculature range of motion and strengthening (39, 40). The National Institute
for Health and Care Excellence (NICE) has established a series of
recommendations: analgesic agents (ibuprofen, paracetamol, or codeine) added to
a provisional course of neuropathic drugs (amitriptyline, pregabalin, or
gabapentin) for patients developing minor neurological signs or for patients
with symptoms lasting more than 4 weeks (31).
It has also been
recommended that patients with non-specific neck pain lasting more than 12
weeks are referred to a pain management clinic, with or without a trial of
neuropathic agents (31).
For patients with a
failed trial of conservative management course or who develop reasons for
surgery, such as a major neurological deficit or interactable pain, several valid
options are available for the surgical intervention of cervical radicular pain
(41).
Some factors, such as
spinal alignment, stability, and balance, play a role in a surgeon’s decision
to use a preferred technique. Surgical approaches can be allocated into two
large categories: anterior and posterior approaches to the spine.
Anterior approach with graft
provides the capability to reestablish cervical segmental lordosis, stabilize
the vertebral spine, enhance
bone fusion, works as weight shearing device, and certainly decompress the
nerve roots directly and indirectly (42, 43). This procedure achieves removal of the whole
intervertebral disc along with any osteophytes formed at the posterior element
of the vertebral body. Historically, the removed intervertebral disc was then
replaced by either autologous bone graft material or even left with nothing (44-49). In recent times, restoration of
normal intervertebral disc height with bone grafts or cages has gained ground (50-52). The ACDF procedure was one of the most performed spinal techniques in the
U.S.A. in the period between 2006 and 2013, with a median of 137,000 cases of
ACDF per year (total cases in 7 years 1,059,403) (53).
In our daily practice, we adopted the ACDF
technique as the procedure of choice. Following this technique and with the
introduction of an allograft, we aim to enhance the rate of fusion and to
increase the degree of postoperative lordosis (54-57). Additionally, introduction of a graft
permits indirect decompression of neural
elements by increasing the cephalocaudal height of the intervertebral space (58).
Although ACDF has a huge success rate in
achieving fusion, restoration of disc space height and lordosis, and indirect
decompression of nerve roots, still have their complications. We carried out a
dedicated analysis of the ACDF cases performed in our center and assessed the
complications encountered and registered (Table 2).
Table
2 Overall
complications encountered.
Complication
|
Percentage
|
Literature percentage
|
P Value
|
Dural penetration
|
1.55%
|
1.7%
|
0.584
|
Superficial wound infection
|
2.07%
|
1.6%
|
0.373
|
Cage mechanical failure
|
2.07%
|
3.21%
|
0.255
|
Horner's syndrome
|
1.04%
|
1.1%
|
0.581
|
Isolated postoperative dysphagia
|
3.63%
|
9.5%
|
0.002*
|
Postoperative hematoma required surgical intervention
|
1.04%
|
5.6%
|
0.001*
|
Symptomatic recurrent laryngeal nerve palsy
|
1.55%
|
3.1%
|
0.001*
|
Esophageal perforation
|
0%
|
00.9%
|
---
|
Adjacent intervertebral disc
|
2.59%
|
9.0%
|
0.001*
|
Pseudoarthrosis
|
1.04%
|
9.1%
|
0.001*
|
Overall morbidity
|
16.58%
|
19.3%
|
0.194
|
* Statistically significant
|
Several analyses have documented the
morbidity/complication rates of the ACDF procedure; they range from 13.2% to
19.3% (59-61). In our review, the overall morbidity
encountered was 16.58%, which was statistically comparable to the
literature (P = 0.194). Morbidity rates are demonstrated in Table 2.
We compared each complication we encountered
with those reported in the literature to evaluate our efficacy and safeness.
Some of these complications might be encountered perioperatively, while others
may evolve later.
Esophageal perforation, one of the major and
fatal complications that might be faced, has been reported in literature in
0.3%–0.9% of cases (61-63). Luckily, we have not had any.
Unintended dural breach, a rare but still serious
complication, occurred in three of our patients (1.55%). In none of our cases
did a cerebrospinal fluid (CSF) fistula develop postoperatively. None of our
patients needed further actions other than the primary closure or applying a fibrin sealant patch with glue. Patients had
no additional consequences. Our results are in line with the literature which
shows 0.5%–1.7% incidence of dural breach (59, 61, 64) (P = 0.584).
Dysphagia, one of the most frequent
postoperative complications, was reported in seven patients (3.63%) and was
resolved spontaneously within 2 weeks. Worldwide reports show a wide range of
dysphagia rates (1.7%–9.5%) (65-67). Our study showed a statistically
significantly lower rate (P = 0.002).
Another common complication is recurrent laryngeal
nerve (RLN) palsy. Previous studies have revealed that RLN palsy incidence is
understated (68, 69). Unilateral vocal paralysis results in dysphonia and/or
hoarseness, which are the most common clinical manifestations, while
respiratory insufficiency might develop due to bilateral RLN palsy (69, 70). In
our analysis, symptomatic RLN palsy was reported in 1.55% of our cases. The
incidence of spontaneous, asymptomatic, preoperative RLN palsy in the
literature is about 1.6% (71, 72). However, around 1.1%–3.1% of patients
undergoing anterior cervical spine surgery develop symptomatic RLN palsy (59,
73). Our study a showed significantly lower rate (P
= 0.001).
Both superficial and deep surgical site
infections exist among the complications of anterior cervical surgery. Reported
rates of surgical site infection are around 0.9%–1.6% (64-66, 74). Our review
identified four cases of superficial wound infections (2.07%), which were
treated with simple dressing and empirical antibiotics, with no significant difference
compared with the literature (P = 0.373).
Although postoperative hematoma arises rarely
in ACDF, it might be a possibly life-threatening complication. Its immediate
detection and surgical evacuation are vital in order to avoid any potential
airway compromise. The reported incidence in previously published reviews is
around 0.2%–2.4% (59, 61, 75, 76). Postoperative hematoma might develop in an
acute or delayed fashion; the majority develop in a delayed fashion, at an
average of 6 days postoperatively (76, 77). Meticulous intraoperative
hemostasis and drain insertion play a cardinal role in preventing a
postoperative hematoma (76). Postoperative wound hematoma that required
surgical evacuation occurred in two cases (1.04%) in our series, which was significantly
lower than in reports in the literature (P < 0.001).
Degeneration of adjacent intervertebral discs
develops due to alteration of the regional biomechanics, increased stress, and
instability of loads to the adjacent intervertebral discs (78-82). Although not
considered a complication of ACDF, there is still a strong correlation.
Recently stated data demonstrate that the incidence of adjacent segment
degeneration after ACDF is around 12.2%, and consequently grows to 25% after a
second ACDF (83, 84). Other studies concluded that 9% of adjacent level disease
develops within 6 years after ACDF, and 7.4% of cases require a reoperation.
The annual incidence of degeneration is around 2.9% per year (85, 86). Our
review revealed five cases (2.59%) with adjacent level disease within 3 years
of the primary surgery, a statistically significant lower rate that in the
literature (P < 0.001).
A well-documented but rare complication
encountered in anterior approaches to the subaxial cervical spine is Horner’s syndrome (87). Horner’s syndrome is
characterized by ipsilateral pupillary miosis, facial anhydrosis, and ptosis,
resulting from damage to the cervical sympathetic trunk. Horner’s syndrome
rarely manifests with significant clinical impairment, but the cosmetic effect
may cause considerable concern (88). Several studies have shown very low
incidence, with rates between 0.02% and 4.0%. Our analysis showed two cases
(1.04%). Symptoms totally resolved in one patient using steroids and speech
therapy, while one female patient suffered from incomplete resolution.
The main aim after decompression of the spine
and nerve roots via ACDF is to achieve fusion. Fusion rates stated in the literature for one- to two-level ACDF were higher
following one-level vs. two-level ACDF and were also higher when using an
autograft (89, 90). The criteria to support bone fusion are the presence of a
trabecular bridging bone formation between the cage and vertebral endplate
documented by CT scan, and a lack of motion confirmed by dynamic cervical X-ray
of the fused levels (91). Studies show fusion rates of 90.1%–100% (92-95). We
achieved a fusion rate of 97.93%, while that for pseudoarthrosis was
significantly lower at 2.07%, confirmed in four cases (P < 0.001).
The accumulative
complication rate encountered in our analysis was 16.58%, with no mortality
occurring. The complications developed were more prominent with increased age,
smoking, and multilevel cases. However, good diagnosis and preoperative
evaluation in addition to good technique would improve outcome.
Although this study
shows good results, it still carries substantial limitations. First, the
present analysis is a retrospective study, hence holding possible biases of
retrospective studies that could
compromise the analysis. Moreover, the small sample size of our cohort may
weaken the statistical power of the conclusions. Nevertheless, the intention of
our analysis was to evaluate treatment of a degenerative cervical disc via the
ACDF procedure, in addition to the associated complications, as many of them
are correlated with the anterior approach per se. Nonetheless, supplementary
studies are still needed to optimize the necessary management approaches and
treatment and to avoid or minimize these complications.
.
CONCLUSION
This study to evaluate
the ACDF procedure for degenerative disk herniation has revealed good or
excellent outcomes in most cases. However, the existence of disruptive
complications, although rare, requires consideration. The study failed to
distinguish possible changeable and modifiable preoperative risk factors that
can minimize or eliminate any complications. The cardinal factors for enhancing
the good result for these patients and their quality of life are a high
awareness level, early identification, and appropriate direct management, which
have vital consequences.
Conflicts of interest: The author certifies
that he has no affiliation with or any direct or indirect involvement in any
organization or entity with any financial interest, or non-financial interest
in the subject matter or materials discussed in this manuscript.
Future work: We need a
prospective, study and a larger population.
Availability
of data and materials: All data generated or analyzed during this study are
included in this published article.
Authors’
contributions: all authors contributed substantially to different article
milestones.
AR:
acquisition of data, writing manuscript, approving final manuscript,
acquisition of data, analysis and interpretation of data. AD: acquisition of
data, analysis and interpretation of data. AI: acquisition of data, analysis
and interpretation of data, HS: analysis and interpretation of data, writing
manuscript, QR: analysis and interpretation of data, drafting manuscript,
conception and design, writing manuscript, approving final manuscript, tables,
diagrams.
Final approval of manuscript: All authors
Agree to be
accountable for all aspects of the work: All authors.
Acknowledgement: We
would like to express our special thanks to Mr. Hijazeen Anis for his time and
efforts he provided throughout this article. His useful advice and highly
professional suggestions were helpful to us during the project's completion.
Ethical Approval
We declare that the
Ethics Committee of Royal Medical Services (No. 9/7/2022) have approved this
study
Informed Consent
Patient's informed
consent was waived as this is a retrospective study.
Funding
The authors had no
relevant funding to disclose.
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