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LONG-TERM CLINICAL AND RADIOLOGICAL OUTCOMES OF ANTERIOR
CERVICAL DISCECTOMY AND FUSION USING A ZERO-PROFILE ANCHORED
CAGE
Azimov Ulugbek Mehriddinovich
Neurosurgeon at the Bukhara Regional Multidisciplinary Hospital
Email: neuro1086@gmail.com
https://doi.org/10.5281/zenodo.13923611
INTRODUCTION
. Cervical discectomy is one of the most common and rapidly growing
procedures performed to quickly relieve radicular and spinal cord compression. As fusion
procedures have gained widespread acceptance, efforts in research and development have
focused on improving and simplifying aspects of these surgeries to enhance patient outcomes.
Various devices, including allograft bone with anterior plating, polyether ether ketone (PEEK)
cages with anterior plating, and other interdiv fusion devices, have been utilized, yielding
mixed results. Despite the numerous technical and biomechanical advancements offering
diverse fusion options, the combination of cages and anterior cervical plates has increased the
risk of complications such as dysphagia.
Technological advances and the discovery of new materials have led to the development
of zero-profile anchored cage systems designed for stand-alone fusion, eliminating the
disadvantages associated with anterior plating. The ROI-C cage (Zimmer Biomet, Austin, TX,
USA) is a cervical interdiv cage with integrated fixation that provides stability to the cervical
spine from the early postoperative period. These implants not only offer immediate
stabilization but also negate the need for anterior plating and iliac crest bone grafting.
Following an initial short-term outcome study, the purpose of this study is to assess the long-
term efficacy and safety of anterior cervical discectomy and fusion (ACDF) using the ROI-C, with
a follow-up period of up to 9 years post-surgery.
Keywords
: Anterior cervical discectomy fusion, cervical disc herniation, cervical
spondylosis functional scores.
METHODS
This was a prospective, multicenter study involving patients who underwent single- or
multi-level anterior cervical discectomy and fusion (ACDF) using ROI-C cages. From January
2018 to January 2023,100 consecutive patients with cervical disc herniation or spondylosis
causing radiculopathy were enrolled. None of the patients had undergone prior cervical spine
surgery before this procedure. All patients had attempted conservative therapy, including rest,
physical therapy, and/or medication, for at least six weeks before surgery. Diagnosis was made
based on preoperative radiographs, computed tomography (CT) scans, and magnetic resonance
imaging (MRI). All participants were deemed suitable candidates for ACDF.
Patients were eligible for enrollment if they were diagnosed with degenerative disc
disease accompanied by symptomatic radiculopathy or myeloradiculopathy at one or two
levels between C-3 and C-7, which corresponded with neural compression at the appropriate
level and side, as confirmed by MRI or CT. Patients with other spinal degenerative conditions,
such as stenosis or arthritis, were included, provided the primary cause of symptoms was nerve
root compression. No exclusions were made based on age, sex, compensation claims, diabetes,
obesity, or other medical conditions that did not contraindicate surgery in general.
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Exclusion criteria included prior spine surgery at the operative levels, ossification of the
posterior longitudinal ligament, significant degenerative or traumatic instability, cervical canal
narrowing requiring posterior decompression in addition to anterior fusion, fractures,
infections, or tumors. Each patient was fully informed about the data collection process and the
objectives of the study.
Outcomes
Each patient was prospectively followed with both preoperative and postoperative
assessments. Data collected included patient demographics (age and gender), intraoperative
details (such as operation duration, levels operated on, types and sizes of implants, and
complications), and postoperative details (length of hospital stay and time to return to work).
Postoperative functional scores, radiological findings, and surgery-related complications were
also documented. Clinical and radiographic evaluations were conducted at hospital discharge,
at 1 and 6 months, and then annually. All patients were included in the evaluations at each
follow-up point.
During follow-up, clinical and radiographic data were gathered at hospital discharge, at 6
weeks, and at 3, 6, and 12 months, with annual follow-ups thereafter. Complications were
classified as implant-related, surgery-related, or general (not directly related to the implant or
surgery). All patients were consistently evaluated at each time point, with a minimum follow-
up period of 4 years (mean follow-up of 7.05 years, ranging from 4 to 9 years).
The primary outcome measures included the Medical Outcomes Study 36-item Short
Form Health Survey (SF-36), Neck Disability Index (NDI), and Visual Analog Scale (VAS) scores
for neck and arm pain. Patients completed questionnaires, either independently or through
interviews, before surgery and at each follow-up visit. Both NDI and VAS scores were measured
on a scale of 0 to 100. Odom’s grading system (poor, fair, good, or excellent) was used to assess
patient satisfaction with the surgery, while myelopathy was graded using the Japanese
Orthopedic Association (JOA) score.
Dysphagia symptoms were evaluated by a physician, based on the patient’s condition, and
graded as none (no swallowing difficulties), mild (rare episodes), moderate (occasional
difficulty with specific foods), or severe (frequent swallowing difficulties with most foods). The
severity of pain (VAS 0–100) and the duration of dysphagia-related symptoms were also
recorded.
RESULTS
A total of 100 patients (54 men and 46 women; mean age of 40.30 years, ranging from 31
to 78 years) were included in this study, and they received a total of 127 ROI-C devices. Among
the patients, 65 (65%) presented with radicular pain, 15 (15%) had myelopathy, and 20 (20%)
experienced both radiculopathy and myelopathy. Most patients had a history of debilitating
neck and arm pain lasting more than 6 weeks that did not respond to physical therapy or anti-
inflammatory medications, or they had developed new neurological deficits due to myelopathy.
All patients had a minimum follow-up of 4 years and a maximum of 9 years, with a mean follow-
up period of 7.05 years.
The mean surgery duration was 77.4 minutes (range: 32 to 160 minutes). Seventy-three
patients (73%) were treated at one spinal level, while 27 (27%) underwent surgery at two
levels.
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Postoperatively, cervical collars were generally not used, except for a few patients who
requested external devices for comfort. Patients were typically permitted to resume normal
daily activities, including driving, 4 weeks after surgery. By 5 weeks post-surgery, they were
allowed to return to all regular activities, with the exception of contact sports, on a permanent
basis. Pain medications were provided as needed after surgery, but anti-inflammatory
medications were avoided during the first 8 weeks. The average length of hospital stay was 1.95
days (range: 1 to 4 days).
Outcomes
Postoperative outcomes showed significant improvement immediately after surgery (P <
0.001) compared to preoperative baseline measures. At 4 years post-surgery, patients
exhibited substantial reductions in VAS, SF-36, JOA, and NDI scores (P < 0.05), indicating
significant improvements in pain and function [Figure 2]. According to Odom's criteria, 94% of
patients rated their satisfaction with the surgery as either excellent or good, with no significant
changes over the follow-up period (P > 0.05). Only two patients reported minor dysphagia (VAS
scores of 2 and 3), which resolved within 1 and 3 months, respectively.
DISCUSSION
In this study, we prospectively assessed the safety and efficacy of the ROI-C cervical cage,
an integrated fixation system, for anterior cervical discectomy and fusion (ACDF). These results
extend a previous study by presenting outcomes at 4 years post-surgery. The average
hospitalization was 1.95 days, and the mean surgery duration was 77.4 minutes. Patients
experienced significant improvements in outcome measures immediately after surgery (P <
0.001), and at 4 years, they showed substantial reductions in VAS, SF-36, JOA, and NDI scores
(P < 0.05). Using Odom's criteria, 94% of patients rated their satisfaction as excellent or good,
with no significant changes throughout the follow-up period (P > 0.05). Minor dysphagia
occurred in two patients, but it resolved quickly. By the 4-year mark, 97% of patients
demonstrated successful fusion at all operated segments. Overall, clinical outcomes
significantly improved at every follow-up point, showing a high interdiv fusion rate and a low
complication rate. These findings align with other studies evaluating the clinical efficacy of
ACDF using cages with integrated fixation systems.
This is the first prospective study to objectively analyze the use of a cervical cage with an
integrated fixation system for ACDF with follow-up extending up to 9 years. The results indicate
that the use of this PEEK cage in ACDF is safe, supporting its use for long-term treatment. These
integrated fixation systems offer a safe alternative, even over extended follow-ups.
The development of alternative stabilization devices in ACDF aims to avoid complications
associated with autologous or allogenic bone grafts, such as donor site pain, infection,
hematoma, iliac crest fracture, and meralgia paresthetica. Cages have been explored as
potential substitutes for autografts in interdiv fusion to prevent these complications. While
titanium or carbon fiber cages have been widely used for cervical fusion, issues like subsidence,
migration, and structural failure have been reported. PEEK, a nonabsorbable biopolymer, has
been utilized in various industries, including medical devices. PEEK cages are biocompatible,
radiolucent, and have an elasticity similar to bone, showing satisfactory fusion rates, although
fusion may be slightly delayed compared to autograft-containing cages.
The ROI-C cage is made of PEEK Optima (radiolucent) and uses a double anchoring system
to achieve intervertebral fusion. This cage is specifically designed for implantation into the
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cervical disc space post-discectomy, allowing the grafting of either autologous bone or bone
substitutes. The cage's curved, self-guided plating is inserted through a direct anterior
approach, requiring less surgical exposure compared to traditional cervical plates or stand-
alone systems with oblique-angled screws. The system is simple to use, with a minimal learning
curve, and offers immediate stabilization post-implant. The double anchoring system negates
the need for a postoperative collar, with the wings firmly securing the vertebral bodies and
providing stability until fusion occurs.
In this study, the intervertebral height increased significantly from 5.8 ± 0.5 mm pre-
surgery to 7.2 ± 0.3 mm at 1 week post-surgery and 7.5 ± 0.2 mm at 4 years (P > 0.05).
Additionally, the cervical Cobb angle improved from 11.6° ± 3.7° pre-surgery to 22.4° ± 3.4° at
24 months, with no significant changes at subsequent follow-ups (P > 0.05).
CONCLUSIONS
Cervical arthrodesis using a cervical interdiv cage with integrated fixation has proven
to be a safe and effective approach for treating cervical degenerative disc disease. This system
offers a unique insertion technique while ensuring successful fusion and a low incidence of
postoperative complications. Larger randomized controlled trials are needed to further
validate these findings.
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