Sagittal alignment after Bryan cervical arthroplasty.

STUDY DESIGN: Prospective, randomized, Food and Drug Administration Investigational Device Exemption trial from one study site. OBJECTIVE: Examine the radiographic sagittal alignment of the Bryan cervical disc for one-level disease. SUMMARY OF BACKGROUND DATA: Prospective, randomized studies demonstrate Bryan arthroplasty provides statistically better functional outcomes than anterior cervical discectomy and fusion. Uncontrolled case reports describe kyphosis after disc replacement. No prospective study has critically assessed sagittal alignment after cervical arthroplasty. METHODS: Forty-eight patients reviewed with a minimum follow-up of 2 years. Quantitative motion analysis determined the change in overall (C2-C7) and treatment-level sagittal alignment, disc space heights, and range of motion. RESULTS: Preoperatively, overall sagittal alignment was equivalent in the two groups. At 24-month follow-up, overall lordosis for the cohorts was not statistically different from preoperative values for each group. In addition, overall lordosis was not significantly different at 24 months when comparing Bryan patients with the fusion patients. The average change in disc angle from preoperative to immediate postoperative at the treated level in the Bryan disc group was a nonsignificant increase in lordosis of 0.92°. The anterior disc height was the same at all time points, but the posterior disc height was slightly (0.7 mm) more in the Bryan than in the fusion patients (P = 0.04). The angular range of motion in the Bryan group was statistically equivalent at all time points. At the fused levels, average range of motion decreased from 6.4° to 0.9° at 24 months (P < 0.0001). CONCLUSION: With the Bryan disc, there was an insignificant increase in lordosis of 0.9° at immediate postoperative time point. Overall cervical sagittal alignment is not different between the experimental and control populations. This prospective study does not demonstrate a clinically significant increase in segmental kyphosis after Bryan disc arthroplasty. Global cervical lordosis is statistically equivalent between arthroplasty and fusion groups at 2 years follow-up.

A comparison of the shock-absorbing properties of cervical disc prosthesis bearing materials.

BACKGROUND DATA: Cervical arthroplasty offers theoretical advantages over traditional spinal fusion, including elimination of adjacent segment disease and elimination of the risk of pseudoarthrosis formation. Initial studies of cervical arthroplasty have shown promising results, however, the ideal design characteristics for disc replacement constructs have not been determined. The current study seeks to quantify the differences in the shock absorption characteristics of three commonly used materials in cervical disc arthroplasty. METHODS: Three different nucleus materials, polyurethane (PU), polyethylene (PE) and a titanium-alloy (Ti) were tested in a humidity- and temperature-controlled chamber. Ten of each nucleus type underwent three separate mechanical testing protocols to measure 1) dynamic stiffness, 2) quasi-static stiffness, 3) energy absorption, and 4) energy dissipation. The results were compared using analysis of variance. RESULTS: PU had the lowest mean dynamic stiffness (435 ± 13 N/mm, P < .0001) and highest energy absorption (19.4 ± 0.1 N/mm, P < .0001) of all three nucleus materials tested. PU was found to have significantly higher energy dissipation (viscous damping ratio 0.017 ± 0,001, P < .0001) than the PE or TI nuclei. PU had the lowest quasi-static stiffness (598 ± 23 N/mm, P < .0001) of the nucleus materials tested. A biphasic response curve was observed for all of the PU nuclei tests. CONCLUSIONS: Polyurethane absorbs and dissipates more energy and is less stiff than either polyethylene or titanium. LEVEL OF EVIDENCE: Basic Science/Biomechanical Study. CLINICAL RELEVANCE: This study characterizes important differences in biomechanical properties of materials that are currently being used for different cervical disc prostheses.

Quality of spinal motion with cervical disk arthroplasty: computer-aided radiographic analysis.

STUDY DESIGN: Kinematic study of a single site in an investigational device exemption trial. OBJECTIVE: Evaluate the center of rotation (COR) after Bryan cervical arthroplasty and compare adjacent segment motion after cervical disk arthroplasty and fusion using validated radiographic analysis. SUMMARY OF BACKGROUND DATA: The goal of cervical arthroplasty is to reestablish spinal kinematics after anterior decompression. Excellent maintenance of range of motion has been reported for a variety of the prostheses; however, the manner the prostheses perform this task is different. A parameter that may be as important as range of motion is restoring the quality of motion. One of the important components is the COR that is easily studied biomechanically but has not been reported from in vivo studies. Furthermore, the effects on the quality of motion at adjacent levels have not been studied. The purpose of this study is to determine the quality of motion after Bryan cervical disk arthroplasty at the target level and the adjacent segments. METHODS: The first 48 patients diagnosed with single level cervical disk degenerative disease and associated myelopathy or radiculopathy from a single institution enrolled in the Bryan disk investigational device exemption trial were selected for inclusion. Twenty-two investigational patients and 26 anterior cervical discectomy and fusion controls were evaluated radiographically preoperatively and 3, 6, 12, and 24 months postoperatively. These results were analyzed using Quantitative Motion Analysis software manufactured by Medical Metrics Inc. Kinematic parameters included translation, sagittal rotation, anterior/posterior disk height, and the calculation of the COR both in the sagittal and coronal planes. RESULTS: At the arthroplasty level, the COR shifted more posterior (0.3 mm, 1% end plate width) and cephalad (4.9 mm, 20% end plate width) compared with the preoperative position, however, this change was not statistically significant (P=0.06). The variability of the COR, however, was less after arthroplasty compared with preoperative values. There was no significant difference in the short term between the adjacent levels after fusion compared with the prosthesis. At later time points (12 and 24 mo), however, the COR was significantly posterior at the level above arthroplasty compared with fusion (P<0.01). COR X was not significantly (P>0.3) different below fusions compared with arthroplasty. Sagittal rotation significantly increased at the level above for both the fusion and prosthesis groups. A trend was noted for increased translation (2.5% end plate width) at the level above a fusion compared with the Bryan disk at 24 months postoperatively, but this did not reach statistical significance. CONCLUSIONS: Sagittal rotation increases above the level of the arthroplasty and fusion. In the long term, the arthroplasty group had a more posterior COR at the level above, compared with the level above a fusion. Translation at the level above a fusion was slightly increased but not statistically compared with the level above the arthroplasty with similar amounts of sagittal rotation (flexion/extension). Although not reaching statistical significance, the COR seemed to shift more posterior and cephalad at the arthroplasty level with less variability compared with the preoperative position.

Cervical disc arthroplasty compared with arthrodesis for the treatment of myelopathy.

BACKGROUND: Although there have been case reports describing the use of cervical disc arthroplasty for the treatment of myelopathy, there is a concern that motion preservation may maintain microtrauma to the spinal cord, negatively affecting the clinical results. As we are not aware of any studies on the use of arthroplasty in this scenario, we performed a cross-sectional analysis of two large, prospective, randomized multicenter trials to evaluate the efficacy of cervical disc arthroplasty for the treatment of myelopathy. METHODS: The patients in the current study were a cohort of patients who were enrolled in the United States Food and Drug Administration Investigational Device Exemption studies of the Prestige ST and Bryan disc replacements (Medtronic, Memphis, Tennessee). The inclusion criteria were myelopathy and spondylosis or disc herniation at a single level from C3 to C7. Clinical outcome measures were collected preoperatively and at six weeks, three months, six months, twelve months, and twenty-four months postoperatively. RESULTS: A total of 199 patients were included in the present study; 106 patients (53%) underwent arthroplasty, whereas ninety-three (47%) underwent arthrodesis. The Neck Disability Index, Short Form-36 scores, and specific arm and neck pain scores improved significantly from baseline at all time points. Patients in all four groups had improvement in the postoperative neurological status and gait function; at twenty-four months after surgery, 90% (95% confidence interval, 77.8% to 96.6%) of the patients in the arthroplasty group and 81% (95% confidence interval, 64.9% to 92.0%) of those in the arthrodesis group had improvement in or maintenance of the neurological status in the Prestige ST trial and 90% (95% confidence interval, 75.8% to 97.1%) of the patients in the arthroplasty group and 77% (95% confidence interval, 57.7% to 90.1%) of those in the arthrodesis group had improvement in or maintenance of the neurological status in the Bryan trial. CONCLUSIONS: We found that patients in both the arthroplasty and arthrodesis groups had improvement following surgery; furthermore, improvement was similar between the groups, with no worsening of myelopathy in the arthroplasty group. While the findings at two years postoperatively suggest that arthroplasty is equivalent to arthrodesis for the treatment of cervical myelopathy for a single-level abnormality localized to the disc space, the present study did not evaluate the treatment of retrovertebral compression as occurs in association with ossification of the posterior longitudinal ligament, and we cannot comment upon the treatment of this condition.

Motion analysis of bryan cervical disc arthroplasty versus anterior discectomy and fusion: results from a prospective, randomized, multicenter, clinical trial.

STUDY DESIGN: Prospective, randomized, multicenter clinical trial. OBJECTIVE: Kinematic analysis of target level and adjacent motion segments after Bryan artificial cervical disc replacement versus anterior cervical fusion. SUMMARY OF BACKGROUND DATA: Disc arthroplasty has been shown to provide short-term clinical results that are comparable or better than those attained with traditional anterior cervical discectomy and fusion. One purported benefit of arthroplasty is the ability to prevent or delay adjacent level operations. METHODS: All patients received either a single-level anterior cervical discectomy and fusion with an anterior cervical plate (Atlantis anterior cervical plate, n=221) or a single-level artificial cervical disc replacement (Bryan cervical disc prosthesis, n=242) at C3 to C7. Flexion, extension, and neutral lateral radiographs were obtained preoperatively, and at regular intervals of 24 months. Cervical vertebral bodies were tracked to calculate the functional spinal unit motion parameters, including flexion/extension range of motion and translation. If visible, the functional spinal unit parameters were obtained at the operative level as well as the level above and below. RESULTS: Significantly more motion was retained in the disc replacement group than the plated group at the index level. The disc replacement group retained an average of 7.95 degrees at 24 months. The preoperative motion was 6.43 degrees and there was no evidence of degradation of motion over 24 months. In contrast, the average range of motion in the fusion group was 1.11 degrees at 3-month follow-up and gradually decreased to 0.87 degrees at 24 months. The preoperative motion was 8.39 degrees. The Bryan disc did not migrate. At 24-month follow-up, there was no case of subsidence of the Bryan disc. There was no evidence of bridging bone across any of the Bryan implant disc spaces. CONCLUSIONS: The Bryan disc treatment, on average, maintained flexion/extension range of motion without degradation over 24 months. No ectopic bridging ossification was seen in any of the Bryan discs and no subsidence or displacement of the Bryan disc occurred.

Long-term outcome after implantation of the Prestige I disc in an end-stage indication: 4-year results from a pilot study.

OBJECT: The long-term function of an artificial cervical disc device is critical to its clinical success. The Prestige I Cervical Disc System has been used clinically since June 1998, and long-term results can now begin to be assessed. The authors conducted clinical and radiographic examinations at 3 and 4 years postoperatively to evaluate the longterm performance of the Prestige I device. METHODS: A pilot trial was initiated in which the Prestige I disc was implanted in a cohort of patients with end-stage disease, who often had a history of multiple previous fusion procedures. All patients were followed according to a standardized clinical and radiographic protocol until 2 years postoperatively. Outcome measures included the Short Form-36 (SF-36) and Neck Disability Index (NDI) questionnaires, neurological status, and radiographic status. To evaluate the long-term function of the device, Ethics Committee approval was obtained to assess the patients at 3 and 4 years postoperatively. All patients were contacted, and after signing an additional informed consent document, were reevaluated according to the standardized protocol. Of the 17 patients in the original cohort, 13 were evaluated at 3 years and 14 were evaluated at 4 years postoperatively. Clinical outcome measures including the NDI and SF-36 showed good improvement, especially when the endstage nature of the disease is considered. Radiographic analysis showed that the Prestige I disc maintained motion at the treated segment at 3 and 4 years postoperatively. CONCLUSIONS: In this report the authors demonstrate the clinical viability of the Prestige I cervical disc system at long-term postoperative intervals, even in the more severe biomechanical environment of end-stage disease.

Clinical outcomes with the Prestige II cervical disc: preliminary results from a prospective randomized clinical trial.

OBJECT: A prospective, randomized clinical trial was conducted to compare the Prestige II Cervical Disc with anterior decompression and fusion for the treatment of single-level degenerative disease. Standardized clinical outcome measures and radiographic examinations were used at prescribed postoperative intervals to compare the treatment groups. METHODS: Patients with symptomatic single-level cervical disc disease who met the inclusion/exclusion criteria defined in the protocol were randomized to receive the Prestige II disc or iliac crest autograft fusion. All patients underwent a standardized neurological and radiographic examination and completed outcomes questionnaires (Neck Disability Index and Short Form-36) preoperatively and at each postoperative interval (6 weeks and 3, 6, 12, and 24 months). Two independent radiologists reviewed all x-ray films and assessed motion at the treated level and adjacent segments. Standard statistical methods were used to compare all outcome measures. Preliminary results in 55 patients enrolled in the study are presented. Several patients have reached the final (24-month) follow-up interval. Clinical and radiographic results are encouraging, with significant improvement seen in both treatment groups. Radiographic results show that the Prestige II disc maintains motion at the treated level without adjacent-segment compromise. CONCLUSIONS: Cervical spine arthroplasty is an exciting and rapidly developing surgical treatment option. An objective comparison with fusion is important to advance this option. This is the first prospective randomized trial in which cervical arthroplasty is compared with fusion. The preliminary results from this limited number of patients indicate that the Prestige II disc is potentially a viable alternative to fusion for primary cervical disc disease; however, further clinical studies with larger sample sizes will be required to show statistical equivalence.

Biomechanical testing of an artificial cervical joint and an anterior cervical plate.

An in vitro biomechanical study was conducted to determine the effects of fusion and nonfusion anterior cervical instrumentation on cervical spine biomechanics in a multilevel human cadaveric model. Three spine conditions were studied: harvested, single-level artificial cervical joint, and single-level graft with anterior cervical plate. A programmable testing apparatus was used that replicated physiologic flexion/extension and lateral bending. Measurements included vertebral motion, applied load, and bending moments. Relative rotations at the superior, implanted, and inferior motion segment units (MSUs) were normalized with respect to the overall rotation of those three MSUs and compared using a one-way analysis of variance (P < 0.05). Application of an anterior cervical plate decreased motion across the fusion site relative to the harvested and artificial joint spine conditions. The reduced motion was compensated for by an increase in motion at the adjacent segments. Use of an artificial cervical joint did not alter the motion patterns at either the instrumented level or the adjacent segments compared with the harvested condition for all modes of testing.

The new Frenchay artificial cervical joint: results from a two-year pilot study.

STUDY DESIGN: A clinical prospective observational cohort study of 15 patients undergoing cervical intervertebral disc replacement. OBJECTIVE: To assess the safety, clinical stability, and capacity of a newly designed cervical intervertebral disc replacement for preserving motion in the cervical spine of patients with degenerative disc disease. SUMMARY OF BACKGROUND DATA: Anterior cervical discectomy and interbody fusion results in loss of motion segments and there is evidence of accelerated degenerative changes occurring at adjacent levels. Intervertebral disc replacement may be a valid alternative to fusion. There is a need for cervical disc replacement to be evaluated in prospective studies before it can be adopted as an acceptable surgical technique. METHODS: The study enrolled 15 patients with cervical radiculopathy or myelopathy and radiologically confirmed cervical disc herniation or posterior vertebral body osteophytes. Eligibility for the study required that patients have either a previous adjacent-level surgical or congenital spinal fusion or radiologic evidence of adjacent-level degenerative disc disease. After decompressive surgery via an anterior approach, all 15 patients received the artificial joint. Follow-up visits were at set intervals and included clinical examination, radiologic assessment, and evaluation by patient-completed questionnaires. RESULTS: In all cases, the artificial joint maintained motion at the operative levels while reestablishing intervertebral height. The procedure was considered safe for experienced spine surgeons to perform, and the device was stable, with no dislocation of components or backing out of screws. Two screws broke, but without any consequence. Improvements in assessment scores were noted. CONCLUSIONS: Cervical intervertebral motion can be maintained with the new device, which is clinically stable. Meticulous attention must be paid to the surgical technique to maximize the chances of a good result. The pilot study was successful, although it has yet to be determined what conditions will benefit most from this technology.

Influence of an artificial cervical joint compared with fusion on adjacent-level motion in the treatment of degenerative cervical disc disease.

OBJECT: The authors report the preservation of motion at surgically treated and adjacent spinal segments after placing an artificial cervical joint (ACJ) and they describe the influence of interbody fusion on changes in angulation occurring in the sagittal plane at adjacent levels in the treatment of cervical spondylosis. METHODS: The authors conducted a prospective nonrandomized study of patients in whom an ACJ was placed or autologous bone graft interbody fusion was performed. Angular measurements at levels adjacent to that surgically treated were calculated using plain flexion-extension radiographs obtained at 6-month intervals. Analyses of qualitative data, such as increase or decrease in adjacent-level motion, and the degree of disc degeneration were performed. Quantitative data were also analyzed. In the fusion group a significant increase in adjacent-level movement was demonstrated at the 12-month follow-up visit compared with the group of patients in whom ACJs were placed (p < 0.001). The increase in movement occurred predominantly at intervertebral discs that were preoperatively regarded as normal (p < 0.02). An overall reduction in adjacent-level movement was observed in patients who underwent joint replacement, although this was compensated for by the movement provided by the ACJ itself. CONCLUSIONS: Fusion results in increased motion at adjacent levels. The increase in adjacent-level motion derives from those discs that appear radiologically normal prior to surgery. It remains unknown whether ACJs have a protective influence on adjacent intervertebral discs.