Richard T. Holt

A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemptions Study of Lumbar Total Disc Replacement With the CHARITE^ Artificial Disc Versus Lumbar Fusion : Part I : Evaluation of Clinical Outcomes

Study Design. A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial. Objectives. The purpose of this study was to compare the safety and effectiveness of lumbar total disc replacement, using the CHARITÉ™ artificial disc (DePuy Spine, Raynham, MA), with anterior lumbar interbody fusion, for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment. Summary of Background Data. Reported results of lumbar total disc replacement have been favorable, but studies have been limited to retrospective case series and/or small sample sizes. Methods. Three hundred four (304) patients were enrolled in the study at 14 centers across the United States and randomized in a 2:1 ratio to treatment with the CHARITÉ™ artificial disc or the control group, instrumented anterior lumbar interbody fusion. Data were collected pre- and perioperatively at 6 weeks and at 3, 6, 12, and 24 months following surgery. The key clinical outcome measures were a Visual Analog Scale assessing back pain, the Oswestry Disability Index questionnaire, and the SF-36 Health Survey. Results. Patients in both groups improved significantly following surgery. Patients in the CHARITÉ™ artificial disc group recovered faster than patients in the control group. Patients in the CHARITÉ™ artificial discgroup had lower levels of disability at every time interval from 6 weeks to 24 months, compared with the control group, with statistically lower pain and disability scores at all but the 24 month follow-up (P < 0.05). At the 24-month follow-up period, a significantly greater percentage of patients in the CHARITÉ™ artificial disc group expressed satisfaction with their treatment and would have the same treatment again, compared with the fusion group (P < 0.05). The hospital stay was significantly shorter in the CHARITÉ™ artificial disc group (P < 0.05). The complication rate was similar between both groups. Conclusions. This prospective, randomized, multicenter study demonstrated that quantitative clinical outcome measures following lumbar total disc replacement with the CHARITÉ™ artificial disc are at least equivalent to clinical outcomes with anterior lumbar interbody fusion. These results support earlier reports in the literature that total disc replacement with the CHARITÉ™ artificial disc is a safe and effective alternative to fusion for the surgical treatment of symptomatic disc degeneration in properly indicated patients. The CHARITÉ™ artificial disc group demonstrated statistically significant superiority in two major economic areas, a 1-day shorter hospitalization, and a lower rate of reoperations (5.4% compared with 9.1%). At 24 months, the investigational group had a significantly higher rate of satisfaction (73.7%) than the 53.1% rate of satisfaction in the control group (P = 0.0011). This prospective randomized multicenter study also demonstrated an increase in employment of 9.1% in the investigational group and 7.2% in the control group.

Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITÉ artificial disc versus lumbar fusion: Five-year follow-up

BACKGROUND CONTEXT The CHARITE artificial disc, a lumbar spinal arthroplasty device, was approved by the United States Food and Drug Administration in 2004 based on two-year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study. No long-term, randomized, prospective study on the CHARITE disc or any other artificial disc has been published to date. PURPOSE The purpose of this study was to compare the safety and effectiveness at the five-year follow-up time point of lumbar total disc replacement using the CHARITE artificial disc (DePuy Spine, Raynham, MA) with that of anterior lumbar interbody fusion (ALIF) with BAK cages and iliac crest autograft, for the treatment of single-level degenerative disc disease from L4 to S1, unresponsive to nonoperative treatment. STUDY DESIGN/SETTING Randomized controlled trial-five-year follow-up. PATIENT SAMPLE Ninety CHARITE patients and 43 BAK patients. OUTCOME MEASURES Self-reported measures: visual analog scale (VAS); validated Oswestry disability index (ODI version 1.0); Short-Form 36 Questionnaire, and patient satisfaction. Physiologic measures: radiographic range of motion, disc height, and segmental translation. Functional measures: work status. METHODS Of the 375 subjects enrolled in the CHARITE IDE trial, 277 were eligible for the five-year study and 160 patients thereof completed the five-year follow-up. The completers included 133 randomized patients. Overall success was defined as improvement> or =15 pts in ODI vs. baseline, no device failure, absence of major complications, and maintenance or improvement of neurological status. Additional clinical outcomes included an ODI questionnaire as well as VAS, SF-36, and patient satisfaction surveys. Work status was tracked for all patients. Safety assessments included occurrence and severity of adverse events and device failures. Radiographic analyses such as index- and adjacent-level range of motion, segmental translation, disc height, and longitudinal ossification were also carried out. RESULTS Overall success was 57.8% in the CHARITE group vs. 51.2% in the BAK group (Blackwelders test: p=0.0359, Delta=0.10). In addition, mean changes from baseline for ODI (CHARITE: -24.0 pts vs. BAK: -27.5 pts), VAS pain scores (CHARITE: -38.7 vs. BAK: -40.0), and SF-36 questionnaires (SF-36 Physical Component Scores [PCS]: CHARITE: 12.6 pts vs. BAK: 12.3 pts) were similar across groups. In patient satisfaction surveys, 78% of CHARITE patients were satisfied vs. 72% of BAK patients. A total of 65.6% patients in the CHARITE group vs. 46.5% patients in the BAK group were employed full-time. This difference was statistically significant (p=0.0403). Long-term disability was recorded for 8.0% of CHARITE patients and 20.9% of BAK patients, a difference that was also statistically significant (p=0.0441). Additional index-level surgery was performed in 7.7% of CHARITE patients and 16.3% of BAK patients. Radiographic findings included operative and adjacent-level range of motion (ROM), intervertebral disc height and segmental translation. At the five-year follow-up, the mean ROM at the index level was 6.0 degrees for CHARITE patients and 1.0 degrees for BAK patients. Changes in disc height were also similar for both CHARITE and BAK patients (0.7 mm for both groups, p=0.9827). Segmental translation was 0.4 and 0.8mm in patients implanted with CHARITE at L4-L5 vs. L5-S1, respectively, and 0.1mm in BAK patients. CONCLUSIONS The results of this five-year, prospective, randomized multicenter study are consistent with the two-year reports of noninferiority of CHARITE artificial disc vs. ALIF with BAK and iliac crest autograft. No statistical differences were found in clinical outcomes between groups. In addition, CHARITE patients reached a statistically greater rate of part- and full-time employment and a statistically lower rate of long-term disability, compared with BAK patients. Radiographically, the ROMs at index- and adjacent levels were not statistically different from those observed at two-years postsurgery.

Anterior/posterior lumbar fusion versus transforaminal lumbar interbody fusion: analysis of complications and predictive factors.

No previous study has compared the complications between anterior/posterior and transforaminal interbody fusions. We performed a retrospective analysis of 164 patients to compare the complications and associated predictive factors of the two techniques of circumferential lumbar fusion. Fifty-three had same-day anterior/posterior fusion (group 1), and 111 had transforaminal interbody fusion (group 2). Mean operating time (p < 0.0001) and hospital stay (p < 0.0001) was significantly longer for group 1 patients. Average blood loss was greater for group 1 patients (p < 0.01). Higher complication rates were found in group 1 patients (p < 0.004). Wound infection occurred more frequently in patients with adjunctive treatment (p < 0.04). Hospital stay was an independent predictor of complications in both groups. In group 1, body mass index was independently associated with complications. In group 2, both hospital stay and adjunctive treatment were predictive of complications. Transforaminal lumbar interbody fusion is the preferred technique because it is associated with shorter operating time, less blood loss, shorter hospital stay, and lower incidence of complications.

Better treatment of vertebral osteomyelitis using posterior stabilization and titanium mesh cages.

There is no scientific consensus on the role of posterior instrumentation in vertebral osteomyelitis. No study has examined the use of titanium cages to reconstruct the anterior column of the spine with vertebral osteomyelitis. Here the authors evaluated the efficacy of using titanium mesh cages anteriorly and posterior instrumentation after anterior debridement in the surgical treatment of vertebral osteomyelitis. In one center, 21 consecutive patients had surgery for vertebral osteomyelitis. The mean follow-up time was 67 months (range, 24 to 120 months). Ten patients received supplemental posterior instrumentation. Five patients had reconstruction of the anterior column with titanium cages. Greater improvement in sagittal alignment was noted for patients with cages implanted (p = 0.0009) and for those with posterior instrumentation (p = 0.005). Patients who received cages had greater (p = 0.0006) correction of their coronal alignment than did those patients without cages. A trend toward fewer postoperative complications emerged for patients who had posterior stabilization or titanium cages. These results support the use of posterior stabilization and titanium cages in the surgical treatment of vertebral osteomyelitis.

Complications of multilevel cervical corpectomies and reconstruction with titanium cages and anterior plating.

The ideal surgical treatment of multilevel cervical spondylosis remains unclear. This study analyzed the complications in using titanium cages and plating to reconstruct multilevel cervical corpectomies. This was a retrospective analysis of 21 consecutive patients who had multilevel cervical corpectomies and reconstruction with titanium cages and anterior plating. Sixteen had 2-level, one had 2.5-level, three had 3-level, and one had 3.5-level corpectomies. All had reconstruction with titanium cages and anterior plating. Thirty-three percent of the patients developed complications. Radiographs revealed bony consolidation in 95% of patients. Reconstructing multilevel cervical corpectomies with titanium cages and plating is associated with complications. Advantages include rigid immobilization and the avoidance of iliac crest bone graft harvesting. Major complications are largely the result of failures of the cage and plate construct, especially in patients with osteopenic bone. Supplemental posterior stabilization may be considered for cases with spasticity or greater than 2-level corpectomies with profound osteoporosis.

A cost analysis of two anterior cervical fusion procedures.

Multilevel anterior cervical discectomy and fusion (ACDF) remains a difficult problem. A recently described surgical technique for multilevel ACDF has eliminated the morbid complications associated with harvesting iliac crest bone graft (ICBG) while maintaining the advantages of using autologous bone graft. A matched-pairs t test was used to compare the estimated costs of 27 ACDFs using titanium surgical mesh, local autologous bone graft, and anterior plate instrumentation with 27 ACDFs using ICBG and plate fixation. The three variables considered were cage cost, operating time (cost), and hospitalization cost. The estimated costs for the two surgical procedures were not significantly different. Thus, the time saved by not harvesting an ICBG was comparable to the cost of the cage. Harvesting ICBG also increased the morbidity rate by 22%.

The efficacy of anterior spine exposure by an orthopedic surgeon

This retrospective study was designed to document the incidence and types of perioperative complications that occurred with anterior spinal fusion surgery performed solely by an orthopedic spine surgeon. This study is contrasted to previous studies that document complications from anterior approaches performed by an orthopedic surgeon with the assistance of a general or a vascular surgeon. Specifically, the procedures included thoracotomies, thoracolumbar retroperitoneal, and lumbosacral approaches. Our sample consisted of 450 patients who underwent anterior spinal fusion between levels T1 and S1, from 1985 to 1997. Patient and surgery characteristics included age, sex, diagnosis, levels of fusion, blood loss, operative time, hospitalization time, complications, American Society of Anesthesiologists state, assessment of risk factors, previous surgery, and surgical approach used. Average follow-up was 41.69 months, with a minimum of 12 months and a maximum of 132 months. Our results indicated that anterior procedures performed solely by our senior orthopedic surgeon had a lower incidence of complications, less blood loss, and shorter operative time than anterior procedures performed by an orthopedic surgeon and a vascular or a general surgeon. Our findings suggest that the anterior spinal exposure is a safe approach that may be performed solely by a spinal surgeon who is knowledgeable and experienced.

Use of spinous processes to determine the optimal trajectory for placement of lateral mass screws: technical note.

Study Design Retrospective chart analysis. Objective In the current report, we present a new technique for the placement of lateral mass screws from C3 to C7. The safety, complications, and long-term clinical and imaging follow-up were analyzed. To address potential risk factors for this technique, relevant literature was reviewed and discussed herein. Summary of Background Data Multiple techniques have been reported to place lateral mass screws in the subaxial cervical spine. The trajectory used aims to avoid the vertebral artery and the exiting nerve root. Because of inherent differences in determining the screw trajectory for placement, there can be considerable differences among surgeons. Methods A retrospective analysis of our experience over the period from 2003 to 2006 was undertaken. Standard practices for obtaining institutional review board approval were followed. Radiographs, hospital records, and office charts of 34 patients were reviewed. There was an equal distribution between males and females and the mean age was 56.3 years. Pain was the most frequent presentation. The indications for posterior instrumentation included instability secondary to pseudoarthrosis, infection, spondylosis, osseous metastasis, trauma, and iatrogenic etiologies. Results The follow-up period ranged from 1 to 30 months (average 9.1 mo). Postoperative complications included wound infection (3 cases), malpositioned screw (1 case), cerebrospinal fluid leak (1 case), and dislodged rod (1 case). There were no mortalities directly related to the procedure. Conclusions This technique for placement of lateral mass screws yielded adequate fixation without any appreciable neurovascular complications. It provides a useful alternative for screw placement in patients with intact spinous processes.

Prospective, Randomized, Multicenter FDA IDE Study of CHARITÉ Artificial Disc versus Lumbar Fusion: Effect at 5-year Follow-up of Prior Surgery and Prior Discectomy on Clinical Outcomes Following Lumbar Arthroplasty☆

Background Candidates for spinal arthrodesis or arthroplasty often present with a history of prior surgery such as laminectomy, laminotomy or discectomy. In this study, lumbar arthroplasty patients with prior surgery, and in particular patients with prior discectomy, were evaluated for their clinical outcomes at the 5-year time point. Methods Randomized patients from the 5-year CHARITÉ investigational device exemption (IDE) study were divided as follows: 1) fusion prior surgery (excluding prior decompression with fusion) group (FSG); 2) fusion prior discectomy group (FDG); 3) fusion no prior surgery group (FNG); 4) arthroplasty prior surgery group (ASG); 5) arthroplasty prior discectomy group (ADG); and 6) arthroplasty no prior surgery group (ANG). The 5-year clinical outcomes included visual analog scale (VAS), Oswestry Disability Index 2.0 (ODI), patient satisfaction, and work status. Results In the arthroplasty group, all subgroups had statistically significant VAS improvements from baseline (VAS change from baseline: ASG = -36.6 ± 29.6, P < 0.0001; ADG = -40.2 ± 30.9, P = 0.0002; ANG = -36.5 ± 34.6, P < 0.0001). There was no statistical difference between subgroups (P = 0.5587). In the fusion group, VAS changes from baseline were statistically significant for the FNG and FSG subgroups, but not for the FDG patients (FNG = -46.3 ± 28.8, P < 0.0001; FSG = -24.2 ± 36.4, P = 0.0444; FDG = -26.7 ± 38.7, P = 0.2188). A trend of decreased VAS improvements was observed for FSG versus FNG (P = 0.0703) subgroups. Similar findings and trends were observed in ODI scores (Changes in ODI from baseline: ASG = -20.4 ± 23.8, P < 0.0001; ANG = -26.6±21.1, P < 0.0001; ADG= -17.6 ± 28.6, P = 0.0116; FSG = -14.5 ± 21.2, P = 0.0303; FNG= -32.5 ± 22.6, P < 0.0001; FDG = -10.7 ± 9.4, P = 0.0938). The greatest improvement in work status from preoperative to postoperative was seen in the ADG subgroup (28% increase in part- and full-time employment), while the FDG subgroup showed the greatest reduction in work status (17% decrease). Conclusions Arthroplasty patients with prior surgery or prior discectomy had similar clinical outcomes as arthroplasty patients without prior surgery, while fusion patients with prior surgery or prior discectomy showed trends of lowered clinical outcomes compared to fusion patients without prior surgery or discectomy.

Selection of fusion levels in scoliosis surgery.

Fusion levels are selected with the goal of having a balanced physiologic spine on the postoperative films. We have proposed an algorithm for selecting fusion levels based on the King-Moe scoliosis classification scheme and the flexibility of a compensatory curve. We propose the acronym TEAMS as a pneumonic. Curve type defines the region of the spine to be fused. The ends of the Cobb measurement around the region are the temporary endpoints. The endpoints are extended to avoid an apex due to the sagittal or frontal planes. The mobile disc is defined at the caudal end of the fusion area. Finally, the bending films, traction films, or intraoperative films are used to define the stable zone of Harrington that must contain the ends of the fusion mass. This scheme yields a simple, easily taught algorithm that results in reproducible endpoints for scoliosis fusion.