Metallosis after traumatic loosening of Bryan cervical disc arthroplasty: a case report and literature review.

PURPOSE: Cervical disc arthroplasty has been a popular alternative to traditional arthrodesis treatment for maintaining postoperative cervical spine mobility. However, certain adverse reactions to cervical disc arthroplasty have emerged during the last few decades. METHODS: Metallosis or metalloma is a rarely reported complication after spinal fusion or spinal arthroplasty surgery. We report on the first metallosis case occurring in a patient who received Bryan Disc implantation approximately 8 years earlier. She was involved in a traffic accident and sustained a whiplash injury to the cervical spine one and a half years ago. The traumatic Bryan Disc loosening developed after the traffic accident, causing metallosis. RESULTS: To the best of our knowledge, this is the first reported case of spinal metallosis caused by the Bryan Disc. A series of metallosis cases reported in the literature are also reviewed. CONCLUSIONS: Although uncommon, intraspinal metallosis or metalloma should be considered as an infrequent cause of delayed neurological symptoms after spinal surgery involving metallic instrumentation, especially after disc arthroplasty. Once metallosis is suspected, immediate metallic implant removal is mandatory for definite diagnosis and treatment.

[Effect of carpentry of Bryan disc on long-term efficacy of cervical artificial disc replacement].

Objective: To evaluate the influence of carpentry of Bryan disc, including artificial disc coverage ratio and shell angular, on long-term efficacy and complications cervical artificial disc replacement. Methods: To retrospectively analyze the clinical data of 86 patients who underwent Bryan disc replacement in Beijing Jishuitan Hospital between 2003 and 2007 (including 101 operated segments). All the patients were followed-up for more than 10 years. Mean age of the patients was (53±9) years, including 51 males and 35 females, and 71 patients underwent single-level and 15 patients underwent two-level artificial disc replacement. Artificial disc coverage ratio and shell angular were measured on postoperative natural X-ray. According to the perfectness of carpentry including 2 parameters (postoperative shell kyphosis and artificial disc coverage ratio smaller than 95%), operated levels were divided into 2 groups: 43 levels in the optimal group and 58 levels in the suboptimal group. Radiographic indexes were evaluated preoperatively and at the last follow-up, included the segmental range of motion(ROM), segmental COBB's angle, the occurrence of segmental mobility lost, segmental kyphosis and the high grade paravertebral ossification(PO). Clinical indexes including Japanese Orthopaedic Association (JOA) score, neck disability index (NDI) and Odom's criteria were evaluated preoperatively and at the last follow-up. The improvement of JOA score, NDI% decline and the satisfaction rate of Odom's criteria were calculated too. The continuous data were analyzed by independent sample t test. The grading data were analyzed by Mann-Whitney test. Results: The mean age of the optimal group was (52±7) years, including 23 males and 14 females; the mean age of the suboptimal group was (54±10) years, including 28 males and 21 females.The baseline data of two groups were comparable. There were significant differences in the segmental ROM, the segmental COBB's angle, the occurrence of segmental mobility lost, segmental kyphosis and the high grade PO between the two groups at the last follow-up (t=5.608, 3.812, χ(2)=15.097, 18.334, 27.141, all P<0.05). The improvement rate of JOA score was 69%±39% and 66%±44%, the NDI% decline was 14%±8% and 11%±8%, the satisfaction rate of Odom's criteria was 97.3% and 83.7% in optimal group and suboptimal group, respectively; there was no significant difference in the up-mentioned indexes between the two groups(t=0.307, 1.483, Z=0.989, all P>0.05). Conclusion: The carpentry of prosthesis will influence the occurrence of segmental mobility lost, segmental kyphosis, and high grade PO with cervical artificial disc replacement in the long run. It is suggested that the artificial disc coverage smaller than 95% and the shell kyphosis should be avoided.

Clinical and radiological analysis of Bryan cervical disc arthroplasty: eight-year follow-up results compared with anterior cervical discectomy and fusion.

PURPOSE: Bryan cervical disc arthroplasty has been reported with satisfactory short- and medium-term clinical results. However, the long-term clinical and radiographic outcomes are seldom reported. The purpose of this study was to compare the eight-year follow-up results in patients who underwent Bryan disc arthroplasty with patients received ACDF, and assess the incidence of heterotopic ossification (HO) and its effect on clinical outcome and mobility of the device. METHODS: Thirty-one patients underwent Bryan disc arthroplasty, and 35 patients underwent ACDF were included in the study. The Japanese Orthopedic Association (JOA) scores, neck disability index (NDI), visual analogue scale (VAS) of neck and arm pain, and the radiographs were used to evaluate the outcomes. The heterotopic ossification (HO) was determined by CT scan and was classified into three subgroups to compare the related effect. Adjacent segment degeneration (ASD) was also observed. RESULTS: At final follow-up, there were no significant differences in JOA scores between two groups, but the improvement in NDI and neck or arm VAS were significantly greater in the Bryan disc cohort. The range of motion at the index level was 7.0° in Bryan group, while 100 % bone fusion were achieved in ACDF group. HO was observed in 18 (51.4 %) levels. There were more restricted movement of the prosthesis and slight higher rate of axial pain in patients with severe-HO (grade III and IV). Fourteen (28.6 %) levels developed ASD in Bryan group, which was significantly lower than that (58.6 %) in ACDF group. CONCLUSIONS: At eight year follow-up, the clinical and radiographic outcomes of Bryan cervical disc arthroplasty compared favorably to those of ACDF. It avoided accelerated adjacent segment degeneration by preserving motion. However, severe HO restricted the ROM of the index levels and maybe associated with post-operative axial pain.

Bone loss of the superior adjacent vertebral body immediately posterior to the anterior flange of Bryan cervical disc.

BACKGROUND: No previous reports have mentioned bone loss of the superior adjacent vertebra immediately posterior to the anterior flange of Bryan cervical disc (Medtronic Sofamor Danek, Memphis, TN, USA), which plays a central role to prevent posterior migration of the device. The purpose of this study is to describe a new potential complication, bone loss immediately posterior to the anterior total disc replacement (TDR) flange on the superior adjacent vertebra following the Bryan cervical TDR and to discuss the possible mechanism. METHODS: The authors retrospectively reviewed 37 patients undergoing cervical TDR with the Bryan cervical disc. The clinical and radiological outcome data were collected at 1, 3, 6, 12, 24, and 36 months postoperatively, and at last follow-up, which ranged from 42 to 113 moths (average, 60.1 months). Clinical evaluation included the visual analog scale and neck disability index, and the radiographic evaluation included measurements of the functional spinal unit range of motion on flexion and extension and identification of radiographic changes such as bone loss. RESULTS: The Bryan TDR showed good mid-term clinical and radiological outcomes. Interestingly, however, bone loss was noted immediately posterior to the TDR flange on superior adjacent vertebra in 3 total patients; at 3 months (n = 2) and 6 months (n = 1). Although the bone loss was increased up to 6 months, this did not progress and no degradation of clinical and radiological outcomes occurred at last follow-up. CONCLUSIONS: Bone loss immediately posterior to the anterior TDR flange on the superior adjacent vertebra can occur in the early postoperative period due to possibly stress shielding effect. However, it did not result in clinical changes or increased rates of graft failure at last follow-up. A long-term follow-up study is mandatory to evaluate the long-term effects of the bone loss.

Polyurethane on titanium unconstrained disc arthroplasty versus anterior discectomy and fusion for the treatment of cervical disc disease: a review of level I-II randomized clinical trials including clinical outcomes.

PURPOSE: To contrast the clinical and radiologic outcomes and adverse events of anterior cervical discectomy and fusion (ACDF) with a single cervical disc arthroplasty design, the polyurethane on titanium unconstrained cervical disc (PTUCD). METHODS: This is a systematic review of randomized clinical trials (RCT) with evidence level I-II reporting clinical outcomes. After a search on different databases including PubMed, Cochrane Central Register of Controlled Trials, and Ovid MEDLINE, a total of 10 RCTs out of 51 studies found were entered in the study. RTCs were searched from the earliest available records in 2005 to November 2014. RESULTS: Out of a total of 1101 patients, 562 were randomly assigned into the PTUCD arthroplasty group and 539 into the ACDF group. The mean follow-up was 30.9 months. Patients undergoing arthroplasty had lower Neck Disability Index, and better SF-36 Physical component scores than ACDF patients. Patients with PTUCD arthroplasty had also less radiological degenerative changes at the upper adjacent level. Overall adverse events were twice more frequent in patients with ACDF. The rate of revision surgery including both adjacent and index level was slightly higher in patients with ACDF, showing no statistically significant difference. CONCLUSIONS: According to this review, PTUCD arthroplasty showed a global superiority to ACDF in clinical outcomes. The impact of both surgical techniques on the cervical spine (radiological spine deterioration and/or complications) was more severe in patients undergoing ACDF. However, the rate of revision surgeries at any cervical level was equivalent for ACDF and PTUCD arthroplasty.

Risk Factors for Cervical Disc Arthroplasty Subsidence with Bryan Disc-A Retrospective Observational Analysis.

Background: Cervical disc arthroplasty (CDA) is currently used instead of fusion to preserve cervical spine motion. Cervical implant subsidence is a potential complication after CDA. Methods: Radiological measurements were recorded via patient anteroposterior and lateral radiographs in the neutral position. Subsidence was defined as a decrease of 3 mm or more in functional spinal unit height (FSUH) from which was measured on a post-operative (OP) radiograph. Results: This study included 104 patients who underwent 153 CDA levels with the Bryan Disc. Approximately one-quarter of the implants (22.9%) showed subsidence. Binary logistic regression analysis indicated that pre-OP mean disc height (DH) was identified as an independent risk factor for subsidence in multivariate analysis (0.151, 95% Confidence Interval 0-0.073, p = 0.018). Receiver operating characteristic curve analysis (area under the curve = 0.852, sensitivity 84.7%, specificity 77.1%) revealed a cut-off value of 4.48 mm for pre-OP Mean-DH in the risk for implant subsidence. Conclusions: In this study, the subsidence rate significantly increased when the implants were oversized beyond a pre-OP Mean-DH of approximately >4 mm. Moreover, the implant subsidence incidence was higher than that reported in previous studies. This is possibly due to endplate over-preparation or disc space over-distraction during placement at the same height as the Bryan Disc (8.5 mm).

Mid-long-term follow-up of operated level kinematics after single-level artificial cervical disc replacement with Bryan disc.

OBJECTIVE: Evaluation of the mid-long-term kinematics of single-level Bryan artificial cervical disc replacement (ACDR) in vivo by analyzing the center of rotation (COR) at the operated level. METHODS: A retrospective analysis was conducted using data collected from 38 patients who underwent single-level Bryan ACDR from January 2010 to March 2013. Radiological parameters including range of motion (ROM), lordosis angle, translation, and COR were obtained. Clinical outcomes were assessed based on Odom Criteria, modified Japanese Orthopedic Association (mJOA), Neck Disability Index (NDI), and Visual Analogue Scale (VAS) scores. Correlations between COR and other follow-up data were discussed at the last follow-up. RESULTS: Compared with preoperative values, the last follow-up data showed that 86.84% of cases achieved good-or-excellent outcomes based on Odom criteria; Significant improvements were observed across all scales assessed for clinical outcomes (P < 0.05); Lordosis angle was significantly increased in both the overall cervical spine and the operated level (P < 0.05); ROM of the overall cervical spine, operated level, and adjacent levels was preserved (P > 0.05); There was no significant change in COR at the operated level (P > 0.05). At the last follow-up and at the operated level, COR (Y) showed negative correlations with ROM and translation (P < 0.05), but no follow-up data correlated with COR (X) were found (P > 0.05). CONCLUSIONS: Satisfactory clinical and radiological outcomes were achieved 7 years or more after single-level Bryan ACDR. At the operated level, preoperative COR was maintained, probably due to replicating the physiological interrelations of COR (Y), translation, and ROM.

Anterior bone loss after cervical Bryan disc arthroplasty: insight into the biomechanics following total disc replacement.

BACKGROUND CONTEXT: Cervical disc arthroplasty (CDA) is an innovative procedure launched in the early 2000s. Compared with anterior cervical discectomy and fusion, many studies show that CDA offers equivalent clinical outcomes while reducing secondary procedures and total cost. PURPOSE: We sought to determine the incidence of anterior bone loss after CDA and the related biomechanical effects. STUDY DESIGN/ SETTING: Retrospective chart review. PATIENT SAMPLE: Patients who underwent CDA with one level Bryan Disc (Medtronic SofamorDanek, Memphis, TN, USA) at one institution. OUTCOME MEASURES: Radiological measurements, including the extent of anterior bone loss, global alignment angle, shell angle, lordotic angle, mean degree of angle of the endplate with the horizontal line, global range of motion (ROM) and ROM of the index level were recorded. The grading of anterior bone loss of the index level was defined as Grade 0, no remodeling; Grade 1, spur disappearance or mild change in body contour; Grade 2, obvious bone regression with Bryan Disc exposure. METHODS: Anatomical measures and ROM were compared by grade of bone loss. RESULTS: Of the 121 patients included in the study, anterior bone loss was found in 53 (43.8%) on the upper adjacent level and 54 (44.6%) on the lower adjacent level. Twenty-nine patients (23.9%) had anterior bone loss in both levels. The majority of cases had Grade 1 anterior bone loss. Grade 2 bone loss was noted in the upper adjacent vertebra in only 5 patients and in 4 patients in the lower adjacent vertebra. Age, sex, operative level, and hybrid surgery had no effect on anterior bone loss. Most radiological assessments, including global alignment angle, lordotic angle, mean degree of angle of the endplate with the horizontal line, global ROM, and ROM of the index level, showed no correlation to anterior bone loss. Shell angle was found to be different in groups with or without remodeling in the upper adjacent level: 5.0 degreesin the Grade 0 group and 7.0 degrees in the Grade 1-2 group, p<.05. CONCLUSIONS: Many more patients than predicted had anterior bone loss. Increasing the shell angle of the artificial disc may increase the incidence of anterior bone loss after CDA. Further study of the biomechanics following CDA should help clarify the mechanisms at work.

Comparison of 10-year Outcomes of Bryan Cervical Disc Arthroplasty for Myelopathy and Radiculopathy.

OBJECTIVE: To evaluate the long-term efficacy of Bryan cervical disc arthroplasty in the treatment of myelopathy patients compared with radiculopathy patients. METHODS: This study is a prospective study. Sixty-six patients (38 patients in myelopathy group and 28 patients in radiculopathy group) who were treated with Bryan cervical disc arthroplasty between 2004 and 2007 and followed for 10 years were included in this study. The Japanese Orthopaedic Association (JOA) score, neck disability index (NDI), and Odom's criteria were used to evaluate the clinical outcomes. X-ray, computed tomography (CT), and magnetic resonance imaging (MRI) were used to evaluate the radiographic outcomes including the global range of motion (ROM), segmental ROM, and segment alignment before the surgery and at last follow-up. The incidence of segmental kyphosis, segmental mobility lost, and the grade of paravertebral ossification (PO) were also evaluated at last follow-up. RESULTS: The JOA score and NDI improved in both groups. Thirty-three of 38 patients in myelopathy group and all patients in radiculopathy group reported good or excellent outcomes according to Odom's criteria. The segmental ROM was (9.5° ± 4.4°) before surgery and maintained at (9.0° ± 5.5°) at last follow-up in myelopathy group. The segmental ROM was (9.5° ± 4.6°) and (9.0° ± 5.3°) before surgery and at last follow-up in radiculopathy group, respectively. The Bryan prosthesis remained mobile at last follow-up for 30 patients (78.9%) in the myelopathy group and 22 patients (78.6%) in the radiculopathy group. Of the patients in the myelopathy group, 21.1% developed segmental kyphosis, as did 21.4% of patients in the radiculopathy group. The incidence of PO and high-grade PO was 92.1 and 28.9% in the myelopathy group, and was 92.9 and 32.1% in the radiculopathy group. There was no significant difference between both groups. CONCLUSIONS: Bryan cervical disc arthroplasty was an effective and safe technique in treating patients with myelopathy. The clinical and radiographic outcomes in the myelopathy group were similar to those in the radiculopathy group at the 10-year follow-up.

Biomechanical Analysis of the Cervical Spine Following Disc Degeneration, Disc Fusion, and Disc Replacement: A Finite Element Study.

BACKGROUND: Discectomy and fusion is considered the "gold standard" treatment for clinical manifestations of degenerative disc disease in the cervical spine. However, clinical and biomechanical studies suggest that fusion may lead to adjacent-segment disease. Cervical disc arthroplasty preserves the motion at the operated level and may potentially decrease the occurrence of adjacent segment degeneration. The purpose of this study was to investigate the effect of disc generation, fusion, and disc replacement on the motion, disc stresses, and facet forces on the cervical spine by using the finite element method. METHODS: A validated, intact, 3-dimensional finite element model of the cervical spine (C2-T1) was modified to simulate single-level (C5-C6) and 2-level (C5-C7) degeneration. The single-level degenerative model was modified to simulate both single-level fusion and arthroplasty (total disc replacement [TDR]) using the Bryan and Prestige LP discs. The 2-level degenerative model was modified to simulate a 2-level fusion, 2-level arthroplasty, and single-level disc replacement adjacent to single-level fusion (hybrid). The intact models were loaded by applying a moment of ±2 Nm in flexion-extension, lateral bending, and axial rotation. The motion in each direction was noted and the other modified models were loaded by increasing the moment until the primary C2-T1 motion matched that of the intact (healthy) C2-T1 motion. RESULTS: Both Bryan and Prestige discs preserved motion at the implanted level and maintained normal motions at the adjacent nonoperative levels. A fusion resulted in a decrease in motion at the fused level and an increase in motion at the unfused levels. In the hybrid construct, the TDR (both) preserved motion adjacent to the fusion, thus reducing the demand on the other levels. The disc stresses followed the same trends as motion. Facet forces increased considerably at the index level following a TDR. CONCLUSION: The Bryan and Prestige LP TDRs both preserved motion at the implanted level and maintained normal motion and disc stresses at the adjacent levels. The motion patterns of the spine with a TDR more closely resembled that of the intact spine than those of the degenerative or fused models.

Does index level sagittal alignment determine adjacent level disc height loss?

OBJECTIVE: The authors sought to compare the effect of index level sagittal alignment on cephalad radiographic adjacent segment pathology (RASP) in patients undergoing cervical total disc arthroplasty (TDA) or anterior cervical discectomy and fusion (ACDF). METHODS: This was a retrospective study of prospectively collected radiographic data from 79 patients who underwent TDA or ACDF and were enrolled and followed prospectively at two centers in a multicenter FDA investigational device exemption trial of the Bryan cervical disc prosthesis used for arthroplasty. Neutral lateral radiographs were obtained pre- and postoperatively and at 1, 2, 4, and up to 7 years following surgery. The index level Cobb angle was measured both pre- and postoperatively. Cephalad disc degeneration was determined by a previously described measurement of the disc height/anteroposterior (AP) distance ratio. RESULTS: Sixty-eight patients (n = 33 ACDF; n = 35 TDA) had complete radiographs and were included for analysis. Preoperatively, there was no difference in the index level Cobb angle between the ACDF and TDA patients. Postoperatively, the ACDF patients had a larger segment lordosis compared to the TDA patients (p = 0.002). Patients who had a postoperative kyphotic Cobb angle were more likely to have undergone TDA (p = 0.01). A significant decrease in the disc height/AP distance ratio occurred over time (p = 0.035), by an average of 0.01818 at 84 months. However, this decrease was not influenced by preoperative alignment, postoperative alignment, or type of surgery. CONCLUSIONS: In this cohort of patients undergoing TDA and ACDF, the authors found that preoperative and postoperative sagittal alignment have no effect on RASP at follow-up of at least 7 years. They identified time as the only significant factor affecting RASP.

Heterotopic ossification following cervical total disc replacement: iatrogenic or constitutional?

OBJECTIVE: To elucidate etiological factors of heterotopic ossification (HO) by evaluating retrospectively if HO is a unique finding following cervical total disc replacement (CTDR) or a finding observable following an anterior cervical interbody fusion (ACIF). METHODS: The authors had selected 87 patients who underwent anterior cervical surgery (TDR or ACIF), and could be followed up more than 24 months. A cervical TDR was performed using a Bryan disc or a ProDisc-C and an ACIF using a stand-alone cage or fibular allograft with a plate and screws system. The presence of HO was determined by observing plain radiography at the last follow up. The relation between HO occurrence and specific preoperative radio-logical findings (osteophyte and calcification of posterior longitudinal ligament (PLL)) at the index level was investigated. RESULTS: Cervical TDR was performed in 40 patients (43 levels) and ACIF in 47 patients (54 levels). At the final radiographs, HO was demonstrated at 27 levels (TDR-Bryan; 8/18, TDR-Prodisc-C; 12/25, ACIF-cage alone; 7/29, and ACIF-plate screw; 0/25). Mean ROM at the last follow-up of each TDR subgroup were 7.8±4.7° in Bryan, 3.89±1.77° in Prodisc-C, and it did not correlated with the incidence of HO. Fusion status of ACIF groups was observed as 2 case of grade 1, 6 of grade 2, and 21 of grade 3 in cage alone subgroup, and no case of grade 1, 4 of grade 2, and 21 of grade 3 in plate screw subgroup. Fusion status in ACIF-cage alone subgroup was significantly related to the HO incidence. The preoperative osteophyte at the operated level observed in 27 levels, and HO was demonstrated in 12 levels (TDR-Bryan; 3/5, TDR-Prodisc-C; 2/3, ACIF-cage alone; 7/11, and ACIF-plate screw; 0/8). Preoperative PLL calcification at the operated level was observed 22 levels, and HO was defined at 14 levels (TDR-Bryan; 5/5, TDR-Prodisc-C; 4/5, ACIF-cage alone; 5/7, and ACIF-plate screw; 0/5). The evidence of preoperative osteophyte and PLL calcification showed statistically significant relations to the occurrence of HO. CONCLUSION: HO was observed in both TDR and ACIF groups. HO was more frequently occurred in TDR group regardless of prosthesis type. In ACIF group, only cage alone subgroup showed HO, with relation to fusion status. Preoperative calcification of longitudinal ligaments and osteophyte were strongly related to the occurrence of HO.