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Back to Journal »Medical Devices: Evidence and Research» Volume 10

Author: Bucci MN, Oh D, Cowan RS, Davis RJ, Jackson RJ, Tyndall DS, Nehls D

Published on April 18, 2017 2017 Volume: 10 pages 61-69

DOI https://doi.org/10.2147/MDER.S127133

Single anonymous peer review

Editor approved for publication: Dr. Scott Fraser

Michael N Bucci,1 Dennis Oh,2 R Scott Cowan,3 Reginald J Davis,4 Robert Jackson,5 Dwight S Tyndall,6 Daniel Nehls7 1Piedmont Spine and Neurosurgical Group, PA, Greenville, SC, USA; 2Spur, Massachusetts, USA Bestate Medical Center, Linfield; 3New England Orthopedic Surgeons, Inc., Springfield, Massachusetts, USA; 4Greater Baltimore Medical Center, Baltimore, Maryland, USA; 5 Orange County Neurosurgery Association, California, USA Guna Hill; 6 Orthopedics Specialist in Northwest Indiana, Minster, Indiana, USA; 7 The Francis Neurosurgery Association of St. Joseph Medical Center, Tacoma, Washington, USA, introduced: Anterior Cervical Discectomy and Fusion (ACDF) has become a treatment The gold standard for cervical degenerative disc disease (cDDD). The use of anterior plates in ACDF increases the risk of complications, such as screw or plate displacement, soft tissue injury, perforation of the esophagus, and dysphagia. The ROI-C™ implant system consists of a zero-profile intervertebral fusion cage and a self-locking plate. It is designed for independent fusion without external plates or screws. Objective: The purpose of this report is to describe the ROI-C™ implant system with VerteBRIDGE™ anchor plate, including indications for use, surgical techniques, preclinical testing and clinical research results. The purpose of the clinical study is to evaluate the incidence of fusion status, dysphagia, and other device-related complications, as well as patient-reported results. Methods: This is a retrospective, multicenter cohort study that included 110 patients receiving ACDF and ROI-C at seven research centers. The patient chart and X-rays were reviewed to determine if there were any complications or equipment malfunctions. The final follow-up was conducted prospectively and included the collection of neck disability index and visual analog scale (VAS) neck and arm pain scores. Results: The average operation time was 73 minutes, and the average blood loss was 25 mL (range 0-75 mL). The average follow-up time was 20.7 months (range 9.5-42.2). Two patients (1.8%) reported dysphagia, and 99.1% achieved fusion. One patient was radiologically confirmed to have a false joint at 12 months, was asymptomatic and did not require surgery. One patient underwent follow-up surgery due to degeneration of adjacent segments. The average neck disability index, VAS neck pain, and VAS left and right arm pain scores at the final follow-up were 19, 26.5, 12.5, and 15.3, respectively. Conclusion: The ROI-C interbody fusion cage with VerteBRIDGE anchor plate achieves a high fusion rate and a low incidence of dysphagia. These patients had similar or better results compared with ACDF treated with anterior teeth plates reported in the peer-reviewed literature. Keywords: ROI-C, zero-profile gasket, ACDF, independent cage, cervical disc degeneration

Cervical degenerative disorders (such as degenerative disc disease or cervical spondylotic myelopathy) are characterized by disc degeneration of the cervical spine. Cervical disc degeneration is a common cause of neck pain. Disc damage caused by degenerative disc disease can cause discogenic pain; however, not all degenerated discs cause pain. In addition to the mild pain of neck stiffness or stiffness, many patients with cervical disc degeneration will also cause numbness, tingling, or even weakness in the neck, arms, or shoulders due to nerve stimulation or discomfort in the cervical spine area. pinch. Aging, genetics, metabolic disorders and mechanical stress are known risk factors for cDDD. 1 The progression of cDDD can lead to intervertebral space collapse, intervertebral disc herniation, spinal stenosis, and radicular arm pain, with or without neurological deficits. If conservative treatment fails, patients often undergo anterior cervical discectomy and fusion (ACDF). Since Smith and Robinson and Cloward first described ACDF, 1, 2 many technical modifications have been reported.

Currently, surgeons can use autologous bone grafts, allogeneic bone grafts, synthetic materials and/or intervertebral fusion cages as insert grafts. For decades, the use of anterior iliac bone grafts for anterior interbody fusion has been the gold standard. Although autologous iliac bone grafts have achieved very successful fusion, the use of such grafts has been greatly reduced due to the morbidity of the donor site. 3-7

The middle bone graft is usually combined with the front locking plate to increase the immediate postoperative stability after the intervertebral bone graft. The front plate increases the rigidity of the fixation and reduces the risk of nonunion, which can lead to kyphosis and false joints, especially in multi-segment cases. 8-12 In addition, the front steel plate can also reduce the risk of graft compression. 13 However, the anterior cervical plate implantation in the pelvis increases the risk of hardware-related complications, such as screw or plate displacement, soft tissue injury, esophageal perforation, nerve palsy and dysphagia, and may lead to degeneration of adjacent segments and osteophytes form. 14-19

To prevent these complications, cages have been studied and applied to humans as potential bone substitutes for autografts in intervertebral fusion. ROI-C™ implant system (ROI-C, Zimmer Biomet, Austin, TX, USA) is composed of ROI-C zero-profile interbody fusion cage and VerteBRIDGE™ self-locking plate, designed for independent fusion. The first clinical use of ROI-C occurred in 2008. In February 2009, the US Food and Drug Administration approved the ROI-C system for single-stage treatment of degenerative cervical spondylosis. The purpose of the clinical study is to evaluate the occurrence of fusion, dysphagia, and other short-term complications, as well as the postoperative efficacy of patients receiving ACDF using the ROI-C system.

The ROI-C implant system consists of "D"-shaped blocks with various footprints and heights (Figure 1). The ROI-C implant system consists of a radiolucent polyether ether ketone (PEEK) Optima® LT1 cage with radiographic location markers in a tantalum alloy. PEEK is a non-absorbable biopolymer that has been used in various industries, including medical devices. The PEEK cage is biocompatible, radiolucent, and has an elastic modulus similar to bone. ROI-C titanium-coated implants provide a porous plasma titanium coating, made of non-alloy non-ferromagnetic titanium (Ti), sprayed on the upper and lower surfaces of the implant.

Figure 1 ROI-C cervical cage using VerteBRIDGE plating technology.

Note: (A) side view; (B) front view; (C) superior vision.

The curved shape of the ROI-C anatomical implant allows contact with the optimal surface area of ​​the vertebrae that embody the curved surface morphology. The ROI-C and ROI-C titanium-coated implant systems also include a lordotic shape, which allows contact with the optimal surface area of ​​the vertebrae that embody a flat surface morphology. In order to promote a faster fusion rate, the ROI-C cage has a closed chamber that can be filled with autologous or allogeneic bone grafts. To prevent the device from moving and provide greater joint stability, both the upper and lower surfaces of the implant have tooth patterns.

The ROI-C implant system is designed to be inserted using the anterior approach. To provide the stability required for successful fusion, the cage is implanted with two VerteBRIDGE anchor plates. The VerteBRIDGE bone plate is made of surgical titanium (Ti6Al4V) and is used to fix the ROI-C implant to the upper and lower vertebrae at the index level. The VerteBRIDGE anchor plate technology allows the ROI-C implant to be used as a stand-alone structure, but can be supplemented with fixation according to the needs of the patient.

The ROI-C implant system is suitable for mature bone patients with cervical degenerative disc disease (cDDD), accompanied by radiculopathy and/or myelopathy at the level of a single disc from C2 to T1. These patients should have 6 weeks of non-surgical treatment unless they have severe or progressive neurological dysfunction. ROI-C implants are designed to be used with autologous or allogeneic bone grafts composed of cancellous bone and/or cortical cancellous bone grafts.

The ROI-C implant system is implanted through an open anterior approach. Two VerteBRIDGE anchor plates are required for supplementary internal fixation to use the system correctly. The ROI-C implant system is designed to be compatible with the optional supplementary fixation device. It is specifically used to fix the ROI-C cage to the lower vertebra using the VerteBRIDGE anchor plate, and specifically allows the choice of independent configurations. Depending on the needs of the patient, additional or other supplementary fixation can be used.

ROI-C is designed for anterior implantation as an intervertebral spacer. The patient takes the supine position and obtains radiographic imaging in the anteroposterior (AP) and lateral planes to determine the level of the diseased intervertebral disc, the size and placement of the implant, and the insertion of the plate. After successful general anesthesia, the basic techniques of exposure, discectomy, and decompression are performed using standard right or left methods. When necessary, the posterior longitudinal ligament is removed to remove the extruded disc material and/or to determine the appropriate disc height. The cartilage tissue is removed from the endplate by using the surgeon's preferred tool (such as a rongeur, curette, or razor), and the endplate is ground before fusion. Only remove the cartilage part of the vertebral endplate, and retain the bone endplate as much as possible to prevent the cage from sinking.

After the midline is determined, a cage test is used. The ROI-C test has the same dimensions as the implant and provides the best endplate coverage, height recovery and stability. Place the test piece in front of the space, determine the width visually, and insert the selected test piece into the space. Under lateral radiography, confirm the following:

Releasing the traction to evaluate the height that can best restore the anatomical shape of the surgical space and the best stability of the implant. The specimen should not protrude from the edges of the vertebrae.

Then take out the test piece, and insert the final cage end plate of the appropriate size to a sufficient depth under the guidance of lateral fluoroscopy. The central space of ROI-C can be filled with autologous bone to promote osseointegration. Then use the impactor to insert the cage into the intervertebral disc space. If necessary, insert the implant by gently tapping the end of the implant holder. If the implant position is too far forward, you can adjust the AP positioning by turning the adjustable stop from 0 to 5 mm. For every millimeter of advancement of the depth stop, the implant moves backward by 1 millimeter.

Under radiographic imaging, the implant is inserted, and the depth of the implant and the coverage of the endplate are evaluated. The tantalum mark is located 1 mm away from the posterior edge of the implant for positioning reference. The surgeon should confirm that the marker is located at least 1 or 2 mm in front of the root canal to avoid compression of the dura mater. After this, perform AP and lateral fluoroscopy to confirm the proper location and size of the device.

After the fusion cage is implanted, the two cervical spine fixation clips are respectively placed into the upper and lower vertebrae through the front of the fusion cage, and the self-locking function of the fixation clips ensures initial stability. The VerteBRIDGE plates are inserted one by one because the plate path crosses the plate shell part of the implant bracket (ie, the plate inserted into the skull groove will be anchored in the caudal vertebral body and the plate will be inserted into the coccyx) groove Will be anchored in the cranial vertebral body). The second board can only be inserted after the first board is locked. After confirming the position of the plate by radiography, the implant stent was removed, and the surgical incision was flushed and closed in a standard manner.

Post-implantation postoperative care should follow standard surgeon practices, including normal preventive measures for cervical fusion. Since many of these operations are performed in an outpatient setting, most patients can move around on the day of the operation.

Biomechanical evaluation of ROI-C

The ROI-C system undergoes pre-clinical biomechanical testing to evaluate stability and pull-out force. The purpose of this study was to biomechanically evaluate the ROI-C structure compared with traditional bone grafts with front plates and independent PEEK cages with integrated screws.

The cadaver motion segments from the two cervical vertebrae (C2-C3, C4-C5 and C6-C7) were installed in epoxy resin and hydraulically driven spine loading system (MTS 810, MTS Systems, Eden Prairie, MN, USA) )carry out testing. Choose to use the flexibility protocol of pure moment application to provide direct comparison with complete specimens and published data. In flexion and extension, bilateral lateral bending and axial torsion, a pure moment of 2.5 Nm is applied, and an axial preload of 20 N is applied to the machine to maintain the compression of the segment. The pull-out test is used to compare resistance to expulsion. A force is applied at a speed of 10 mm/min under an axial preload of 50 N to measure the peak extraction load. The vertebrae are allowed to rotate during the extraction test.

The average flexion and extension of the complete structure is 12.9±3.6°, the lateral bending is 9.7±2.6°, and the axial torsion is 10.3±1.3°. Compared with the complete structure, the range of motion (ROM) of ROI-C with VerteBRIDGE steel plate is 39%–53%, the average flexion and extension is 6.6±3.3°, the lateral bending is 3.8±2.4°, and the axial torsion is 5.5 ±2.5 °. In each test direction, compared with the complete sample, the range of motion of ROI-C is significantly reduced (p≤0.01). Compared with a separate PEEK cage with two screws and a traditional PEEK cage with a cervical lamina structure, the range of motion (percentage of complete ROM) of ROI-C in all directions is also smaller (Figure 2). The average pull-out load of ROI-C is greater than the reported pull-out load of traditional cervical lamina (232.7 N and 202 N, respectively), which is much higher than the expected physiological load. 20 The failure of ROI-C extraction was only due to ploughing and the opening of the device through the bone and the segment (lordosis).

Figure 2 The range of motion of the ROI-C with a VerteBRIDGE anchor plate, a polyetheretherketone (PEEK) cage with a front steel plate, and a PEEK cage with screws.

Note: The range of motion is expressed as a percentage of the complete sample ROM. PEEK cage data from Freeman et al. 21

Abbreviations: ROM, range of motion; belt, belt; belt 2, belt 2

In flexion and extension, lateral bending and axial torsion, the ROI-C with VerteBRIDGE anchor plate showed lower ROM than the published data plate. The extraction resistance of ROI-C with VerteBRIDGE plate is comparable to the published bone graft data with cervical plate and screw22. When additional rejection resistance is required instead of a separate cage, ROI-C with VerteBRIDGE plating proved to be a viable option.

This is a retrospective, multi-center study of patients receiving single-segment ACDF. The patient used an independently configured ROI-C cage with a VerteBRIDGE anchor plate and autologous bone graft (Figure 3). Collect surgical data and patient demographic information from 110 patients in seven research centers in the United States (registration number NCT02104167; ClinicalTrials.gov). All patients signed a written informed consent to participate in the study. The Western Institutional Review Board (IRB) approved the research protocols of the five centers, and the local hospital IRB approved the approval of two centers (Baystate Medical Center, Springfield, Massachusetts, USA; St. Joseph Medical Center, Tacoma, Washington, USA). The inclusion criteria included a diagnosis of DDD at a level between C2 and T1, radiographically confirmed radiculopathy and/or myelopathy, and corresponding pain and/or neurological deficits. The implantation took place between January 2011 and November 2013. All patients had agreed before data collection. Data were collected retrospectively before and during the operation, as well as the 2nd and 6th months. The last follow-up was conducted prospectively between December 2013 and January 2015. The fusion state was determined using AP, lateral, and flexion/extension radiographs at each time point, and was defined as the presence of segmental bridging bone flexion/extension movements of less than 2° and AP translation of less than 3 mm. Equipment integrity is assessed radiologically for subsidence, false joints, and equipment-related complications. The clinical examination at the last follow-up includes measuring the neck disability index (NDI), using the visual analog scale (VAS) 0-100 to measure neck and nerve root pain, 0 means no pain, and 100 means severe pain. Adverse events and dysphagia were also collected. The results of the study were compared with the results of recent ACDF publications. Literature comparisons are derived from peer-reviewed publications of randomized studies by the US Food and Drug Administration that report 2-year results of single-layer ACDF with steel plates and screws.

Figure 3 Postoperative X-ray of ROI-C using VerteBRIDGE anchor plate at C4-C5 level.

Note: (A) Front and rear view; (B) Side view.

The study cohort included 64 women and 46 men. The average age is 51.9±10.2 years (Table 1). 28 patients (25.5%) had undergone cervical spine surgery. All patients developed radiculopathy and/or myelopathy, accompanied by pain and paresthesias. All procedures are single-stage ACDF with ROI-C. Operation levels include C3–C4 to C7–T1. In each case, the autograft was added to the cage and no supplemental fixation was used. The average operation time is 73 minutes. The average estimated blood loss is 25 mL (range 0-75 mL). Patients were discharged after an average hospitalization of 0.7 days (range 0-2 days).

Table 1 Preoperative and surgical details

Abbreviations: BMI, body mass index.

The average follow-up time was 20.7±8.8 months. The average NDI, VAS neck pain, VAS right arm pain, and VAS left arm pain scores at the last follow-up were 19, 26.5, 12.5, and 15.3, respectively (Table 2). The incidence of dysphagia at 2, 6, and 12 months were 8.2%, 2.3%, and 1.8%, respectively (Table 3). 29.2% of patients at 2 months, 85.7% at 6 months, and 99.1% of patients achieved fusion at the last follow-up.

Table 2 Final follow-up results of the ROI-C study

Abbreviations: ACDF, anterior cervical discectomy and fusion; NDI, cervical disability index; VAS, visual analog scale.

Table 3 Comparison of ROI-C dysphagia and fusion rate with literature

Note: a The average follow-up was 20.8 months.

Abbreviations: ACDF, anterior cervical discectomy and fusion.

There was 1 case of false joint (0.9%) and 1 case of secondary operation (0.9%). One patient confirmed the false joint by imaging at 12 months. The patient was asymptomatic (NDI score = 4; neck and arm pain score = 0) and did not receive surgical treatment. The second patient initially underwent ROI-C C3-C4 surgery and was diagnosed with cervical spinal canal stenosis with multiple adjacent segments of myelopathy (C4-C6). Although ROI-C has been successfully fused, the patient underwent C3-C6 fusion 8 months after the initial surgery.

In the current study, we have demonstrated that the zero-section ROI-C cage has similar or better clinical and radiological results compared to ACDF with a front plate. During the postoperative follow-up, no internal fixation loosening, detachment, fracture, instability, or sinking occurred in our study. The sinking of the intervertebral fusion cage can cause a variety of complications, including foramen and disc height reduction, segmental spinal instability, and loss of lordosis. 23 Retaining the cortical endplate is a key factor in preventing the sinking of the intervertebral fusion cage. It has been proven that the preparation of the endplate reduces the strength and rigidity of the vertebral body. 24,25 The surgical technique of the ROI-C implant system requires minimal endplate preparation. Clinical evidence suggests that ROI-C and other intervertebral fusion cages should have a low sinking rate. twenty four

Compared with ACDF using steel plates and screws, ROI-C implants leave less hardware in the patient's body. In addition, although the use of a ROI-C cage does not always mean a smaller skin incision compared to the ACDF that uses a plate; it does involve less anatomy and smaller exposure of the prevertebral space. The related benefit is less trauma to surrounding soft tissues. It also has obvious advantages when performing C7-T1 fusion. In this fusion, it does not need to be exposed farther than the intervertebral disc space itself. The implantation of ROI-C is particularly valuable when existing boards exist at adjacent levels. This situation requires a larger exposure to extend to the other end of the board to remove it in order to place the new board on the new target level. With ROI-C, there is no need to remove the existing adjacent board, and in fact there is no need to expose it at all because it can be placed separately. In situations where the anchor occasionally encounters an existing screw in the shared vertebral body, only the screw can be removed instead of the entire plate, which requires minimal exposure expansion.

Because nonunion is associated with poor prognosis, the main goal of 10 ACDF is to achieve solid bone fusion, thereby preventing delayed kyphosis with stenosis of the intervertebral foramina that may cause root compression and neck pain. 26,27 We found that ROI-C is associated with a high bone fusion rate (99.1%). Grasso et al. 28 and Wang et al. 29 reported 100% fusion of ROI-C patients and followed up for 2 years. Hoffstetter et al. 30 reported the fusion of ROI-C (95.2%) and ACDF (96%) after average follow-up The rate is similar to 13.9 months. It is reported that the fusion rate of ACDF with anterior steel plate is increased compared with ACDF without steel plate. 13,31–33 The fusion rate of ACDF and cervical plate for single-segment surgery is estimated to be 97.1%. 33 In contrast, randomized controlled clinical trials involving patients treated with ACDF front plate and allogeneic bone had a fusion rate of 89% to 96.6% at 24 months. 34-38

The zero-profile ROI-C anchor cage combines intervertebral support and supplementary fixation into one device. An integral part of the ROI-C system are two VerteBRIDGE anchor plates, which eliminate the basic shortcomings of independent cages. These unique structures provide a fixing mechanism similar to the function of steel plates and screws. We believe that the self-locking VerteBRIDGE bone plate can ensure excellent initial stability of the implant and promote early fusion. In addition, the elastic modulus of the anchor cage is similar to that of bone, which theoretically helps reduce stress shielding and increase bone fusion. The anatomical shape of the anchoring cage (its upper protruding part is located in the frontal and sagittal planes) allows a wide graft space and close contact between the endplate bone and the implant.

In our study, the ROI-C implant system with VerteBRIDGE anchor plate showed a lower rate of dysphagia at 6 (2.3%) and 12 months (1.8%), respectively. Other studies on ROI-C have reported the same low rate of dysphagia (0%–3.1%). 28-30 In contrast, it has been reported that the rate of dysphagia after the use of the front plate ACDF is as high as 35.1%. 39 Some studies have shown a higher incidence of postoperative dysphagia after using the pre-locking plate. 13,40,41 Bazaz et al.40 observed that patients who did not use the front plate had a lower incidence of dysphagia (14.1%) compared with those who received front plate fixation (21.1%). The structure includes a front locking plate. Mobbs et al.13 observed a similar trend. The dysphagia rate (4.5%) of patients who received the front locking plate was significantly higher than that of the structure without the front plate (0.8%).

Although the cause of dysphagia after ACDF surgery is unclear, several physiological mechanisms have been proposed. The occurrence of dysphagia and dysphonia is related to the following reasons, such as damage to the trachea or esophagus soft tissue by the anterior steel plate or compression 41, 42 or scar tissue at the incision. 43 Due to the locking plate of the anterior cervical spine, irritation or impact may occur 13,40,41,44 The design and thickness of the front locking plate are also related to postoperative swallowing difficulties. 41 Front locking plate Another possible mechanism for dysphagia after ACDF may be the need for additional traction to place the front locking plate. Lock the board. It is believed that the increase in esophageal pressure during anterior plate implantation can cause difficulty in swallowing in patients receiving anterior plate ACDF. 45 In contrast, the ROI-C implant system does not require a front plate to stabilize the joint. This zero-profile design reduces the possibility of dysphagia and dysphonia by avoiding compression of soft tissues, and the use of curved anchor plates instead of screws can achieve a smaller surgical incision without exceeding the size of the cage.

There is a growing consensus that ACDF changes the natural course of cervical spondylosis and accelerates the development of degenerative changes at the level directly above and below the fusion area. In this retrospective study, one patient (0.9%) had adjacent segment degeneration and required subsequent fixation in the adjacent segment. Hofstetter et al30 reported that two ROI-C patients (5.7%) required repeated surgery for adjacent segment disease. Schwab et al46 found that cervical fusion reduces the number of vertebrae with mobility and causes biomechanical changes. In order to maintain the function of the entire cervical spine, the body will increase the activity of the adjacent fused vertebral segments to compensate, causing the adjacent segments to degenerate. The presence of plates and screws may also accelerate the degenerative changes of adjacent segments.47 Anterior interbody fusion may also lead to the degeneration of adjacent segments.48 However, the exact pathophysiological mechanism of adjacent segment degeneration is unclear. .

The design of the ROI-C implant system utilizes the core principles of previous intervertebral fusion devices to take advantage of the safety and successful clinical history of anterior intervertebral fusion devices, while addressing some of the shortcomings of previous intervertebral implants. The clinical results of the ROI-C implant system showed positive clinical results with high fusion rate and low sinking rate, dysphagia, reoperation and degeneration rate of adjacent segments. The elegant design and ease of use of the ROI-C with VerteBRIDGE locking plate represents an improved surgical option that can achieve stable anterior interbody fusion without the need for anterior plate or posterior fixation. The possible advantages of ROI-C for spinal fusion surgery include shorter operation time, less anatomy and less exposure of prevertebral space, as well as less implanted hardware, and related benefits of less trauma to surrounding soft tissues.

Dr. Reginald J Davis is currently affiliated with Tampa Laser Spine Institute, Tampa, FL 33607. WB Dolman (Zimmer Biomet) is responsible for data analysis and preparation of drafts, tables and figures.

This research was supported by LDR Spine USA, Inc. (now Zimmer Biomet). Each author is an investigator of the ROI-C retrospective study and received research support during the study period. MNB and RJJ served as consultants to LDR and Zimmer Biomet. The authors report no other conflicts of interest in this work.

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