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Masahiro Kanayama, Bryan W. Cunningham, Charles J. Haggerty, Kuniyoshi Abumi, Kiyoshi Kaneda and Paul C. McAfee

Object. Interbody fusion devices are rapidly gaining acceptance as a method of ensuring lumbar interbody arthrodesis. Although different types of devices have been developed, the comparative reconstruction stability remains controversial. It also remains unclear how different stress-shielded environments are created within the devices. Using a calf spine model, this study was designed to compare the construct stiffness afforded by 11 differently designed lumbar interbody fusion devices and to quantify their stress-shielding effects by measuring pressure within the devices.

Methods. Sixty-six lumbar specimens obtained from calves were subjected to anterior interbody reconstruction at L4–5 by using one of the following interbody fusion devices: four different threaded fusion cages (BAK device, BAK Proximity, Ray TFC, and Danek TIBFD), five different nonthreaded fusion devices (oval and circular Harms cages, Brantigan PLIF and ALIF cages, and InFix device); two different types of allograft (femoral ring and bone dowel) were used. Construct stiffness was evaluated in axial compression, torsion, flexion, and lateral bending. Prior to testing, a silicon elastomer was injected into the cages and intracage pressures were measured using pressure needle transducers.

Conclusions. No statistical differences were observed in construct stiffness among the threaded cages and nonthreaded devices in most of the testing modalities. Threaded fusion cages demonstrated significantly lower intracage pressures compared with nonthreaded cages and structural allografts. Compared with nonthreaded cages and structural allografts, threaded fusion cages afforded equivalent reconstruction stiffness but provided more stress-shielded environment within the devices.

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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.

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Yoshihisa Kotani, Bryan W. Cunningham, Kuniyoshi Abumi, Anton E. Dmitriev, Manabu Ito, Niabin Hu, Yasuo Shikinami, Paul C. McAfee and Akio Minami

Object. This in vitro experimental study was conducted to investigate the initial biomechanical effect of artificial intervertebral disc replacement in the cervical spine. The multidirectional flexibility of replaced and adjacent spinal segments were analyzed using a cadaveric cervical spine model.

Methods. The following three cervical reconstructions were sequentially performed at the C5–6 level after anterior discectomy in seven human cadaveric occipitocervical spines: anterior artificial disc replacement with a bioactive three-dimensional (3D) fabric disc (FD); anterior iliac bone graft; and anterior plate fixation with iliac bone graft. Six unconstrained pure moments were applied with a 6-df spine simulator, and 3D segmental motions at the operative and adjacent segments were measured with an optoelectronic motion measurement system. The 3D FD group demonstrated statistically equivalent ranges of motion (ROMs) when compared with intact values in axial rotation and lateral bending. The 45% increase in flexion—extension ROM was demonstrated in 3D FD group; however, neutral zone analysis did not reach statistical significance between the intact spine and 3D FD. The anterior iliac bone graft and iliac bone graft reconstructions demonstrated statistically lower ROMs when compared with 3D FD in all loading modes (p < 0.05). The adjacent-level ROMs of the 3D FD group demonstrated nearly physiological characteristics at upper and lower adjacent levels. Excellent stability at the interface was maintained during the whole testing without any device displacement and dislodgment.

Conclusions. The stand-alone cervical 3D FD demonstrated nearly physiological biomechanical characteristics at both operative and adjacent spinal segments in vitro, indicating an excellent clinical potential for cervical artificial disc replacement.

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Richard B. North, Vito R. LaRocca, Jacob Schwartz, Catherine A. North, Marianna Zahurak, Randy F. Davis and Paul C. McAfee

Object. Refinement of surgical techniques, especially anterior approaches, for the management of spinal metastases has improved patient outcomes, despite the fact that a complete analysis of the prognostic factors that would inform patient selection has not been undertaken. The authors sought to identify such prognostic factors for neurological outcome and life expectancy in patients with spinal metastases.

Methods. The authors used Kaplan—Meier techniques, log-rank comparisons, and a multivariate model stratified by tumor type to identify prognostic factors for duration of ability to walk and survival in patients who underwent surgical treatment for spinal metastases during a decade when all current treatment options were available.

Preoperatively, 53 (87%) of the 61 patients in the study population suffered neurological symptoms (for example, weakness) and 52 (85%) were ambulatory. Postoperatively, 59 (97%) were ambulatory. Most patients who survived 6 months (81%) remained ambulatory, as did 66% of those alive at 1.6 years. The median postoperative survival was 10 months. The risk factors for loss of ambulation were preoperative loss of ambulatory ability, recurrent or persistent disease after primary radiotherapy of the operative site, a procedure other than corpectomy, and tumor type other than breast cancer. Prognostic factors for reduced survival were surgical intervention extending over two or more spinal segments, recurrent or persistent disease after primary radiotherapy involving the operative site, diagnosis other than breast cancer, and a cervical spinal procedure.

Conclusions. The results of this analysis allowed the authors to create a simple prognostic factor scoring system that can be applied to individual patients. The positive experience derived from this study supports an expanded role for the surgical treatment of metastatic spinal disease.

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Bryan W. Cunningham, Paul C. McAfee, Fred H. Geisler, Gwen Holsapple, Karen Adams, Scott L. Blumenthal, Richard D. Guyer, Andrew Cappuccino, John J. Regan, Ira L. Fedder and P. Justin Tortolani

Object

One of the goals of lumbar arthroplasty is to restore and maintain range of motion (ROM) and to protect adjacent levels from abnormal motion, which may be a factor in transition syndrome following arthrodesis. In this study, in vitro ROM results were compared with in vivo, 2-year postoperative radiographic ROM evaluations.

Methods

Radiographs of patients enrolled in the CHARITÉ investigational device exemption study were analyzed at baseline and at 2 years postoperatively. The ROM in flexion/extension at the implanted and adjacent levels was measured, normalized, and compared with ROM results obtained using cadaver (in vitro) evaluations.

Results

Preoperative ROM distributions in patients enrolled for arthroplasty or fusion at the L4–5 level was as follows: 28% motion was observed at L3–4, 35% at L4–5 and 37% at L5–S1. Following a one-level arthroplasty at L4–5, the in vivo ROM distribution from L-3 to S-1 at the 2-year time point was 36% at L3–4, 30% at L4–5 and 35% at L5–S1. Following a one-level fusion with BAK and pedicle screws at L4–5, the in vivo ROM distribution from L-3 to S-1 at the 2-year time point was 45% at L3–4, 9% at L4–5 and 46% at L5–S1.

Conclusions

The baseline as well as the 2-year in vivo data confirmed previously published in vitro data. One-level arthroplasty was shown herein to replicate the normal distribution of motion of the intact spine.

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Paul C. McCormick

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Fred H. Geisler, Richard D. Guyer, Scott L. Blumenthal, Paul C. McAfee, Andrew Cappuccino, Fabien Bitan and John J. Regan

Object

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.

Methods

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).

Results

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).

Conclusions

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.

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Richard D. Guyer, Fred H. Geisler, Scott L. Blumenthal, Paul C. McAfee and Bradford B. Mullin

Object

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.

Methods

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.

Results

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.

Conclusions

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.

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Fred H. Geisler, Richard D. Guyer, Scott L. Blumenthal, Paul C. McAfee, Andrew Cappuccino, Fabien Bitan and John J. Regan

Object

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.

Methods

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.

Results

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).

Conclusions

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.