Wolfhard Caspar, Tobias Pitzen, Luca Papavero, Fred H. Geisler, and Todd A. Johnson
Object. To assess clinical outcome and survival in patients with cervical vertebral spinal neoplasms after they have undergone anterior decompression and cervical plate stabilization (ACPS) by using either autologous bone graft or polymethylmethacrylate (PMMA) as the anterior load-bearing support structure.
Methods. This was a retrospective case study composed of 30 patients harboring cervical spinal vertebral neoplasms who underwent anterior cervical decompression and (ACPS) within a 7-year period. Postoperative immobilization included treatment in a halo brace in two cases and in a hard cervical collar for the remaining patients. Postoperatively most patients underwent radio- and/or chemotherapy. All patients except one benefited from a significantly improved quality of life with decreased pain and/or improved neurological status. The mean Kaplan—Meier survivoral estimate was 35.8 months (range 8 days–11.3 years, with 10 patients alive at most recent follow-up contact). Patients achieved long-term or lifelong mechanical stability in the cervical spine, and only one patient required a repeated posterior stabilization procedure. No hardware-related complications occurred. One patient died 8 days postoperatively of pneumonia. A nonsignificant difference in survival (p = 0.2164) was observed between patients harboring metastatic neoplasms (26.8 months) and those harboring lymphomatous and multiple myeloma neoplasms (54 months).
Conclusions. Favorable clinical outcome of both neurological symptoms and pain can be achieved using ACPS after surgery for neoplasms in the cervical vertebrae. Furthermore, long-term or lifelong cervical spine mechanical stability with bone fusion is achieved using this technique even when radiation therapy is delivered to the site of the bone graft.
Fred H. Geisler, Ali Moghaddamjou, Jamie R. F. Wilson, and Michael G. Fehlings
Methylprednisolone (MP) to treat acute traumatic spinal cord injury (ATSCI) remains controversial since the release of the second National Acute Spinal Cord Injury Study (NASCIS2) in 1990. As two historical studies, NASCIS2 and Sygen in ATSCI, used identical MP dosages, it was possible to construct a new case-level pooled ATSCI data set satisfying contemporary criteria and able to clarify the effect of MP.
The new pooled data set was first modernized by excluding patients with injury levels caudal to T10, lower-extremity American Spinal Injury Association (ASIA) motor scores (LEMSs) ≥ 46, Glasgow Coma Scale scores ≤ 11, and age < 15 or > 75 years, and then standardized to the ASIA grading and scoring format. A new updated NASCIS2 data set from this pooled data set contained 31.6% fewer patients than the 1990 NASCIS2 data set.
In the new pooled data set, recovery of LEMSs from baseline to 26 weeks, the primary outcome variable, was separated statistically into five different injury severity cohorts (p < 0.0001). The severity cohorts contained groups with severe floor (62.9%) and ceiling (10.7%) effects, which do not contribute to drug effects. The new NASCIS2 data set duplicated the p value for MP versus placebo in the sub-subgroup analysis of MP initiated ≤ 8 hours (the subgroup) and recovery of motor function on only the right side of the body (a further subgroup within the ≤ 8-hour subgroup), presented as the positive MP effect in the original NASCIS2 reporting. However, current statistical interpretation considers results seen only in post hoc sub-subgroups, without multi-test corrections, to be random effects without clinical significance. The combined case-level pooled data set from the NASCIS2 and Sygen studies increased the MP group from 106 to 431 patients, creating a new MP combined group. This new data set served as a surrogate for a contemporary MP study and found that administration of MP did not enhance ASIA motor score improvement in the lower extremities at 26 weeks. Secondary analysis of descending ASIA motor and sensory cervical neurological levels in cervical ATSCI patients at 26 weeks also found no MP drug effect.
Analysis of both the new updated NASCIS2 data set and the new case-matched pooled data set from two historical ATSCI studies revealed that administration of MP after spinal cord injury did not demonstrate any enhancement in neurological recovery at 26 weeks. The results of this analysis warrant review by clinical guideline groups.
Paul C. McCormick
Curtis A. Dickman, Mark N. Hadley, Conrad T. E. Pappas, Volker K. H. Sonntag, and Fred H. Geisler
✓ Fourteen patients with superior cervical spinal cord injuries and the clinical signs and symptoms of cruciate paralysis are presented. This rare injury pattern is characterized by weakness of the upper extremities with little or no compromise of lower-extremity function following trauma to the superior spinal cord. Anatomically, cruciate paralysis is thought to represent selective injury to descending corticospinal tracts as they decussate at the cervicomedullary junction. The clinical and radiographic findings of each patient are outlined and the incidence and natural history of the injury syndrome, including a review of the literature, are presented.
Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité intervertebral disc
Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004
Fred H. Geisler, Scott L. Blumenthal, Richard D. Guyer, Paul C. McAfee, John J. Regan, J. Patrick Johnson, and Bradford Mullin
Object. Arthrodesis is the gold standard for surgical treatment of lumbar degenerative disc disease (DDD). Solid fusion, however, can cause stress and increased motion in the segments adjacent to the fused level. This may initiate and/or accelerate the adjacent-segment disease process. Artificial discs are designed to restore and maintain normal motion of the lumbar intervertebral segment. Restoring and maintaining normal motion of the segment reduces stresses and loads on adjacent level segments. A US Food and Drug Administration Investigational Device Exemptions multicentered study of the Charité artificial disc was completed. The control group consisted of individuals who underwent anterior lumbar interbody fusion involving BAK cages and iliac crest bone graft. This is the first report of Class I data in which a lumbar artificial disc is compared with lumbar fusion.
Methods. Of 304 individuals enrolled in the study, 205 were randomized to the Charité disc-treated group and 99 to the BAK fusion—treated (control) group. Neurological status was equivalent between the two groups at 6, 12, and 24 months postoperatively. The number of patients with major, minor, or other neurological complications was equivalent. There was a greater incidence of both major and minor complications in the BAK fusion group at 0 to 42 days postoperatively. Compared with data reported in the lumbar fusion literature, the Charité disc—treated patients had equivalent or better mean changes in visual analog scale and Oswestry Disability Index scores.
Conclusions. The Charité artificial disc is safe and effective for the treatment of single-level lumbar DDD, resulting in no higher incidence of neurological complications compared with BAK-assisted fusion and leading to equivalent or better outcomes compared with those obtained in the control group and those reported in the lumbar fusion literature.
Richard D. Guyer, Fred H. Geisler, Scott L. Blumenthal, Paul C. McAfee, and Bradford B. Mullin
Lumbar arthroplasty is approved in the US for the treatment of degenerative disc disease at 1 level in skeletally mature patients. However, a bias toward older patients (> 45 years of age) who are otherwise indicated for the procedure may exist. In this study, the clinical outcomes of patients from the Charité Investigational Device Exemption (IDE) study were analyzed on the basis of patient age.
There were 276 patients enrolled in the IDE study of the Charité Artificial Disc who underwent 1-level arthroplasty at either L4–5 or L5–S1, including 71 nonrandomized and 205 randomized individuals. Patient data were analyzed based on age (18–45 years [217 patients, Group 1] compared with 46–60 years [59 patients, Group 2]). Statistical analyses were performed based on 2-year postoperative improvements in Oswestry Disability Index (ODI), 36-item Short Form Health Survey (SF-36), and visual analog scale (VAS) scores (clinical outcome), as well as range of motion (radiographic outcome), and adverse events.
There was no significant difference between the groups with respect to level implanted, operative time, blood loss, changes in ODI and VAS scores or any of the 8 component scores of the SF-36, compared with baseline, at all time points throughout the 24-month follow-up period (p > 0.10). Patient satisfaction was equivalent at 24 months, with 87% satisfaction in Group 1 and 85% satisfaction in Group 2 (no statistical difference). In addition, no significant differences were identified with respect to adverse events including approach related, neurological, technique related, or reoperation.
Although patients > 45 years of age may have comorbidities or contraindications for arthroplasty for a number of reasons, particularly osteopenia, this analysis demonstrates that patients who are indicated for 1-level arthroplasty experience similar clinical outcome, satisfaction, or adverse events compared with their younger counterparts.
Fred H. Geisler, Richard D. Guyer, Scott L. Blumenthal, Paul C. McAfee, Andrew Cappuccino, Fabien Bitan, and John J. Regan
Patient selection is perhaps the most important factor in successful lumbar surgery. In this study, the authors analyzed the clinical outcomes of patients enrolled in the CHARITÉ investigational device exemption (IDE) trial who underwent revision surgery after primary total disc replacement with CHARITÉ or an anterior lumbar interbody fusion (ALIF) with placement of a BAK cage and iliac crest autograft. This revision surgery was either a supplemental posterior lumbar fixation or a 360° fusion. Statistical analysis was conducted to compare clinical success in patients who underwent revision surgery with those who did not.
The patients enrolled in the CHARITÉ IDE study were divided into 6 groups according to treatment and repeated operation status, and their Oswestry Disability Index (ODI) and visual analog scale (VAS) scores at the 2-year follow-up and at baseline were compared. The patients had received the following treatments by group: A) ALIF without reoperation; B) ALIF with conversion to 360° fusion; C) arthroplasty (randomized) without repeated operation; D) arthroplasty with supplemental posterior lumbar fixation; E) arthroplasty (nonrandomized) without repeated operation; and F) arthroplasty (nonrandomized) with supplemental posterior lumbar fixation. Outcome scores in the groups of patients who required revision surgeries (Groups B, D, and F; 23 patients) were compared with the groups that did not require revision surgery (Groups A, C, and E; 299 patients).
Patients who required revision surgery had a significantly lower level of clinical improvement than those who did not. The mean change in ODI score was −53.0% in Groups A, C, and E, but just −12.7% in Groups B, D, and F (p < 0.0001). The mean change in VAS score was −59.1% in Groups A, C, and E, compared to −23.4% in Groups B, D, and F (p < 0.0001). No significant differences were identified in analyzing absolute change in scores and the percentage change. A comparison of outcomes in patients who had undergone arthroplasty without reoperation (Groups C and E) with all patients who had undergone revision surgery (Groups B, D, and F) demonstrated similar results (p < 0.0001).
The 7.1% of patients who underwent a secondary stabilization procedure had poor clinical improvement. This finding may indicate that if the alternative treatment had been the initial treatment, these patients would not have benefited, and further implies a 7.1% rate of imprecision in preoperative evaluation.
Fred H. Geisler, Richard D. Guyer, Scott L. Blumenthal, Paul C. McAfee, Andrew Cappuccino, Fabien Bitan, and John J. Regan
A secondary lumbar surgery at a previously surgically treated level is believed to result in minimal clinical improvement. The clinical results of the CHARITÉ Investigational Device Exemption (IDE) study were analyzed to assess the effect of previous surgery on clinical outcomes following either total disc replacement with the CHARITÉ device or anterior lumbar interbody fusion with a BAK cage and iliac crest autograft.
Patients with prior microdiscectomy, laminectomy, or minimal medial facetectomy were not excluded from enrollment in the CHARITÉ IDE study. Thus, the following 3 groups were analyzed: all patients treated with the CHARITÉ Artificial Disc, whether randomized or nonrandomized; only patients treated with CHARITÉ devices randomized against patients with BAK devices; and control patients with BAK devices. Each group was further subdivided based on the patients' medical history, whether they had undergone prior surgery (prior surgery group) or had not (no prior surgery group). For all groups, baseline demographics were collected and compared for any potential recruitment bias. Postoperative improvements based on Oswestry Disability Index (ODI), visual analog scale (VAS), and patient satisfaction scores were further collected and statistically analyzed.
For all 3 groups, there were no statistical differences in clinical improvement from 3 months to 2 years postoperatively as measured using ODI and VAS scores between the subgroups (those who had prior surgery and those who did not).
Patients indicated for 1-level lumbar arthroplasty with previous lumbar decompressive surgery can be expected to have similar clinical outcomes to patients undergoing arthroplasty without prior lumbar decompressive surgery. Similarly, candidates for anterior lumbar fusion with prior decompressive surgery may experience similar benefits from the surgical procedure as those without.