Bryan Cervical Disc Prosthesis Research Articles

Biomechanics of the C5-C6 Spinal Unit Before and After Placement of a disc prosthesis

The study consists of a biomechanical comparison between the intact C5-C6 spinal segment and the same segment implanted with the Bryan artificial disc prosthesis (Medtronic Ltd., Memphis, TN, USA), by the use of the finite element (FE) method. Our target is the prediction of the influence of prosthesis placement on the resulting mechanics of the C5-C6 spine unit. A FE model of the intact C5-C6 segment was built, employing realistic models of the vertebrae, disc and ligaments. Simulations were conducted imposing a compression preload combined to a flexion/extension moment, a pure lateral bending moment and a pure torsion moment, and the calculated results were compared to data from literature. The model was then modified to include the Bryan cervical disc prosthesis, and the simulations were repeated. The location of the instantaneous center of rotation (ICR) of C5 with respect to C6 throughout flexion/extension was calculated in both models. In general, the moment-rotation curves obtained from the disc prosthesis-implanted model were comparable to the curves obtained from the intact model, except for a slightly greater stiffness induced by the artificial disc. The position of the calculated ICRs was rather stable throughout flexion-extension and was generally confined to a small area, qualitatively matching the corresponding physiological region, in both models. These results imply that the Bryan disc prosthesis allows to correctly reproduce a physiological flexion/extension at the implanted level. The results of this study have quantified aspects that may assist in optimizing cervical disc replacement primarily from a biomechanical point of view.

Complications with cervical arthroplasty

Spinal arthroplasty is becoming more widely performed in the treatment of degenerative cervical disc disease. Although this new technology may offer benefits over arthrodesis, it also requires that the surgeon acquire new operative techniques, and new potential complications are introduced. To determine the incidence and distribution of perioperative complications, the authors analyzed their early data obtained in a series of patients treated with the Bryan Cervical Disc prosthesis. The authors prospectively recorded operative data, complications, and clinical and radiographic outcome data in all patients treated with Bryan prosthesis-based arthroplasty at two tertiary care centers since 2001. Patients underwent standard anterior cervical discectomy followed by one- to three-level arthroplasty. Ninety-six discs were implanted in 74 patients. The perioperative complication rate was 6.2% per treated level. In one patient a retropharyngeal hematoma developed, requiring evacuation. Neurological worsening occurred in three patients. Intraoperative migration of the prosthesis was observed in one two-level case, whereas delayed migration occurred in one patient with postoperative segmental kyphosis. In another patient with severe postoperative segmental kyphosis, revision was required with a customized lordotic prosthesis. Heterotopic ossification and spontaneous fusion occurred in two cases; motion was preserved in the remaining 94 prostheses. Partial dislocation of the prosthesis in extension occurred in one patient with preoperative segmental hypermobility, the first reported failure of a Bryan prosthesis. Twenty-five percent of patients reported neck and shoulder pain during the late follow-up period. There was a trend toward increased kyphosis of the C2-7 curvature postoperatively. The Bryan prosthesis was effective in maintaining spinal motion. Major perioperative and device-related complications were infrequent.

The Bryan cervical disc prosthesis as an alternative to arthrodesis in the treatment of cervical spondylosis

We present data relating to the Bryan disc arthroplasty for the treatment of cervical spondylosis in 46 patients. Patients with either radiculopathy or myelopathy had a cervical discectomy followed by implantation of a cervical disc prosthesis. Patients were reviewed at six weeks, six months and one year and assessment included three outcome measures, a visual analogue scale (VAS), the short form 36 (SF-36) and the neck disability index (NDI). The results were categorised according to a modification of Odom's criteria. Radiological evaluation, by an independent radiologist, sought evidence of movement, stability and subsidence of the prosthesis.A highly significant difference was found for all three outcome measurements, comparing the pre-operative with the post-operative values: VAS (Z = 6.42, p < 0.0001), SF-36 (mental component) (Z = -5.02, p < 0.0001), SF-36 (physical component) (Z = -5.00, p < 0.0001) and NDI (Z = 7.03, p < 0.0001). The Bryan cervical disc prosthesis seems reliable and safe in the treatment of patients with cervical spondylosis.

Cervicothoracic Junction Arthroplasty after Previous Fusion Surgery for Adjacent Segment Degeneration: Case Report

This is the first reported case of cervical arthroplasty using the Bryan Cervical Disc Prosthesis System (Medtronic Sofamor Danek, Inc., Memphis, TN) in the management of adjacent segment degeneration associated with previous fusion surgery and surgery at the cervicothoracic junction. This case report describes a 25-year-old woman who initially underwent a two-level anterior cervical fusion in 1998, 2 years after being involved in a motor vehicle accident. She was well until 18 months before presentation, when she developed bilateral shoulder pain, mechanical neck pain worse on flexion, and bilateral C8 distribution arm pain and paresthesia. On clinical examination, no focal deficits were found, although the range of motion was reduced. Preoperative cervical spine x-rays and magnetic resonance scanning confirmed accelerated degeneration of the C4-C5 and C7-T1 disc spaces, with evidence of neural compression at those levels. After careful consideration of various treatment options and failure of all conservative measures, the patient underwent an anterior C4-C5 and C7-T1 decompression with removal of the anterior cervical plate and placement of two artificial disc prostheses. After surgery, her course was uncomplicated and she was discharged from hospital well. There was complete resolution of the arm symptoms and reduction of the neck pain, with a reduction in the amount of analgesia she was taking. Seven months after surgery, she remains well with repeat x-rays confirming motion at the operated levels. This case demonstrates that cervical arthroplasty is a reasonable treatment option for patients who have had previous surgery in which interbody fusion has been performed and who have developed degeneration of adjacent levels. Despite the altered biomechanics at the cervicothoracic junction, no adverse features were noted with arthroplasty at this level.

Sagittal alignment and the Bryan cervical artificial disc

The authors evaluated cervical spine radiographs to determine sagittal alignment in patients who underwent one- or two-level arthroplasty with the Bryan cervical artificial disc prosthesis. The curvature of the surgically treated spinal segments and the overall curvature of the cervical spine were evaluated in 13 patients who underwent 16 cervical arthroplasty device placements. Preoperative and postoperative lateral radiographs were reviewed and compared using standardized techniques for measuring spinal curvature. Patients who underwent a single-level cervical arthroplasty had a 4.7 degrees mean reduction (p < 0.05) in lordosis after cervical artificial disc replacement. The three patients who underwent two-level cervical arthroplasty had no significant changes in the sagittal alignment. Patients who underwent arthroplasty with a Bryan cervical artificial disc had a focal loss of lordosis (that is, kyphosis) at the treated levels after single-level procedures. Nevertheless, there was no significant change in the overall sagittal curvature of the cervical spine after single-level artificial disc replacements. The patients who underwent two-level artificial disc placement had no significant changes in lordosis at the treated levels or in the overall curvature. The likely source of this outcome appears to be the endplate milling procedures that reorient the vertebral endplates.

La prothèse cervicale de bryan ® dans le traitement des affections cervicales dégénératives : À propos d’une expérience préliminaire de 9 implants

After an anterior cervical discectomy, immobility at the fused level may increase stress on adjacent disc spaces and causes disc degeneration in 92% of the cases with clinical manifestations in 25.6% of the patients within 10 years. The cervical disk prosthesis may help to prevent this problem. The Bryan prosthesis (Medtronic Sofamor Danek) is currently available in France after a European pilot study.Since January 2002, 8 patients (9 implants) (mean age: 35 years) were operated on with a prosthesis implantation for disc degeneration after an adjacent previous interbody fusion in 2 patients and for disc herniation or spondylosis in 6 patients. The prosthesis were implanted at the C4-C5 level (one patient), C5-C6 (four patients), and C6-C7 (four patients). Post-operative radiological evaluations with dynamic X-rays and clinical status (Odom questionnaire) were analyzed.Surgical procedures, which were longer than the classical technique, were uneventful. Radicular pain resolved after surgery with excellent results with the Odom's score. With a mean follow-up of 12 months, the prosthesis mobility was 8.9 degrees . But one fusion of an implant was encountered 6 months after implantation.The general follow-up for the Bryan(R) cervical disc prosthesis implantation is still too short (2 years) for a definitive evaluation. If clinical results on pain are as good as expected, long-term mobility of the prosthesis has to be checked, as it is the main advantage over classical anterior cervical discectomy with fusion. Patient selection has to be considered.

Effects of a cervical disc prosthesis on segmental and cervical spine alignment

Cervical arthroplasty offers the promise of maintaining motion of the functional spinal unit (FSU) after anterior cervical discectomy. The impact of cervical arthroplasty on sagittal alignment of the FSU needs to be addressed, together with its effect on overall sagittal balance of the cervical spine. The authors prospectively reviewed radiographic and clinical outcomes in 14 patients who received the Bryan Cervical Disc prosthesis (Medtronic Sofamor Danek, Memphis, TN), for whom early (< 6 months) and late (6-24 months) follow-up data were available. Static and dynamic radiographs were measured by hand and computer to determine the angles formed by the endplates of the natural disc preoperatively, those formed by the shells of the implanted prosthesis, the angle of the FSU, and the C2-7 Cobb angle. The range of motion (ROM) was also determined radiographically, whereas clinical outcomes were assessed using the Neck Disability Index (NDI), and Short Form-36 (SF-36) questionnaires. The ROM was preserved following surgery, with a mean preoperative sagittal rotation angle of 8.96 degrees , which was not significantly different from the late postoperative value of 8.25 degrees . When compared with the preoperative disc space angle, the shell endplate angle in the neutral position became kyphotic in the early and late postoperative periods (mean change -3.8 degrees in the late follow-up period; p = 0.0035). The FSU angles also became significantly more kyphotic postoperatively, with a mean change of -6 degrees (p = 0.0006). The Cobb angles varied widely preoperatively and did not change significantly after surgery. There was no statistical correlation between the NDI and SF-36 outcomes and cervical kyphosis. Cervical arthroplasty preserves motion of the FSU. Both the endplate angle of the treated disc space and the angle of the FSU became kyphotic after insertion of the Bryan prosthesis. The overall sagittal balance of the cervical spine, however, was preserved.

Early clinical and biomechanical results following cervical arthroplasty

Spinal arthroplasty may become the next gold standard for the treatment of degenerative cervical spine disease. This new modality must be studied rigorously to ensure in vivo efficacy and safety. The authors review the preliminary clinical experience and radiographic outcomes following insertion of the Bryan Cervical Disc Prosthesis (Medtronic Sofamor Danek, Memphis, TN). This prospective cohort study included 26 patients undergoing single- or two-level implantation of the Bryan artificial cervical disc for treatment of cervical degenerative disc disease resulting in radiculopathy and/or myelopathy. Radiographic and clinical assessments were made preoperatively 1.5, 3 months, and at 6, 12, and up to 24 months postoperatively. The Neck Disability Index (NDI) and Short Form-36 (SF-36) questionnaires were used to assess pain and functional outcomes. Segmental sagittal rotation from C2-3 to C6-7 was measured using quantitative motion analysis software. A total of 30 Bryan discs were placed in 26 patients. A single-level procedure was performed in 22 patients and a two-level procedure in the other four. Follow-up duration ranged from 1.5 to 27 months, with a mean duration of 12.3 months. A statistically significant improvement in the mean NDI scores was seen between pre- and late postoperative follow-up evaluations. A trend toward improvement in the SF-36 physical component was also found. Motion was preserved in the treated spinal segments (mean range of motion 7.8 degrees ) for up to 24 months postsurgery. The relative contribution of each segment to overall spinal sagittal rotation differed depending on whether the disc was placed at C5-6 or C6-7. Overall cervical motion (C2-7) was moderately increased on late follow-up evaluations. The Bryan artificial cervical disc provided in vivo functional spinal motion at the treated level. Overall cervical spinal motion was not significantly altered. Sagittal rotation did not change significantly at any level after surgery.

Wear Analysis of the Bryan Cervical Disc Prosthesis

In vitro wear testing of the Bryan Cervical Disc prosthesis was performed in a cervical spine simulator. The biologic response was assessed in chimpanzee and goat animal models. Determine the wear characteristics of the Bryan disc. Large joint arthroplasties fail most commonly by wear and consequent formation of particulate material, which induces an inflammatory response. Therefore, measuring the wear characteristics of the new spinal disc replacements is important. Six prosthetic assembles were tested to 10 or 40 million cycles by load and motion and 3 additional assemblies were tested by load only in a cervical spine simulator. Any debris was examined using ASTM standards. The local biologic response to the prosthesis was examined in two chimpanzees. Nine goats were used to assess the biologic response in both local and distant tissues. Arthrodesis was performed on three additional control goats that received an allograft and an anterior cervical plate. Wear results: cervical spine simulators that applied the loads and motions associated with activities of daily living produced wear particulate at a rate of 1.2 mg per million cycles. Device height decreased 0.02 mm per million cycles with approximately 77% of this decrease due to gradual creep of the nucleus under the constant compressive load. Particles generated were granular in shape with a mean feret diameter of 3.9 microm. All animals tolerated placement of the Bryan disc. Wear debris was present in the periprosthetic and epidural spaces in some animals. However, no significant inflammatory response was observed. No wear material was found distant from the implant in draining lymph tissue, the liver, or the spleen. The Bryan disc has satisfactory wear characteristics and does not produce a significant inflammatory response.

Preliminary Clinical Experience with the Bryan Cervical Disc Prosthesis

The concept of accelerated degeneration of adjacent disc levels as a consequence of increased stress caused by interbody fusion of the cervical spine has been widely postulated. Therefore, reconstruction of a failed intervertebral disc with a functional disc prosthesis should offer the same benefits as fusion while simultaneously providing motion and thereby protecting the adjacent level discs from the abnormal stresses associated with fusion. This study was designed to determine whether a new, functional intervertebral cervical disc prosthesis can provide relief from objective neurological symptoms and signs, improve the patient's ability to perform activities of daily living, decrease pain, and provide stability and normal range of motion. We conducted a prospective, concurrently enrolled, multicenter trial of the Bryan Cervical Disc Prosthesis (Spinal Dynamics Corp., Mercer Island, WA) for the treatment of patients with single-level degenerative disc disease of the cervical spine. Patients with symptomatic cervical radiculopathy and/or myelopathy underwent implantation with the Bryan prosthesis after a standard anterior cervical discectomy. At scheduled follow-up periods, the effectiveness of the device was characterized by evaluating each patient's pain, neurological function, and range of motion at the implanted level. Analysis included data regarding 60 patients at 6 months with 30 of those patients at 1 year. Clinical success at 6 months and 1 year after implantation was 86 and 90%, respectively, exceeding the study's acceptance criteria of 85%. These results compare favorably with the short-term clinical outcomes associated with anterior cervical discectomy and fusion reported in the literature. At 1 year, there was no measurable subsidence of the devices (based on a measurement detection threshold of 2 mm). Evidence of anterior and/or posterior device migration was detected in one patient and suspected in a second patient. There was no evidence of spondylotic bridging at the implanted disc space. The measured range of motion in flexion-extension, as determined by an independent radiologist, ranged from 1 to 21 degrees (mean range of motion, 9 +/- 5 degrees). No devices have been explanted or surgically revised. Discectomy and implantation of the device alleviates neurological symptoms and signs similar to anterior cervical discectomy and fusion. Radiographic evidence supports normal range of motion. The procedure is safe and the patients recover quickly. Restrictive postoperative management is not necessary. However, only after long-term follow-up of at least 5 years will it become clear whether the device remains functional, thus confirming these early favorable results. In addition, the influence on adjacent motion segments can be assessed after at least 5 years of follow-up.

Preliminary Clinical Experience with the Bryan Cervical Disc Prosthesis

Preliminary Clinical Experience with the Bryan Cervical Disc Prosthesis