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Yossi Smorgick, Yigal Mirovsky, Yizhar Floman, Nahshon Rand, Michael Millgram, and Yoram Anekstein

OBJECTIVE

The authors evaluated the long-term clinical outcome of a total posterior arthroplasty system in the surgical treatment of lumbar spinal stenosis with degenerative spondylolisthesis.

METHODS

Between June 2006 and July 2007, 10 patients with neurogenic claudication due to spinal stenosis and single-level degenerative spondylolisthesis were enrolled in a nonrandomized prospective clinical study. The patients were evaluated with radiographs and MRI scans, the visual analog scale (VAS) for back and leg pain, the Oswestry Disability Index (ODI), and the SF-36 health survey preoperatively and at 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 7 years, and 11 years postoperatively.

RESULTS

The mean VAS score for leg pain dropped from 83.5 before surgery to 13 at 6 weeks and 17 at 11 years after surgery. The mean VAS score for back pain dropped from 56.2 preoperatively to 12.5 at 6 weeks and 14 at 11 years after surgery. The mean ODI score decreased from 49.1 preoperatively to 13.5 at 6 weeks and 16 at 11 years after surgery. MRI at 11 years demonstrated stenosis adjacent to the stabilized segment in one patient. This patient was not symptomatic. The authors did not find evidence of progression of the spondylolisthesis in any of the cases. In one patient, conversion to posterolateral fusion was performed due to an early device malfunction.

CONCLUSIONS

The results of this 11-year follow-up study demonstrate that, in patients with spinal stenosis and degenerative spondylolisthesis, decompression and posterior arthroplasty maintain clinical improvement and radiological stability.

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Paul McAfee, Larry T. Khoo, Luiz Pimenta, Andy Capuccino, Domagoj Coric, Robert Hes, Bart Conix, Farbod Asgarzadie, Azmi Hamzaoglu, Yigal Mirofsky, and Yoram Anekstein

Object

Total disc replacement is an alternative to lumbar fusion, but patients with spinal stenosis, spondylolisthesis, and facet arthropathy are often excluded from this procedure because increased adjacent-segment motion can exacerbate dorsal spondylotic changes. In such cases of degenerative spondylolisthesis with stenosis, decompression and fusion remain the gold standard of treatment. To avoid attendant loss of motion at the treated segment, the TOPS system is a novel total posterior arthroplasty prosthesis that allows for an alternative dynamic, multiaxial, three-column stabilization and motion preservation. The purpose of this study is to report preliminary surgical data and clinical outcomes in patients treated with the TOPS lumbar total posterior arthroplasty system.

Methods

Twenty-nine patients were enrolled in a nonrandomized, multicenter, prospective pilot study outside the US. All patients had spinal stenosis and/or spondylolisthesis at L4–5 due to facet arthropathy. Radiographs and scores on outcome measures including the visual analog scale (VAS) for pain, Oswestry Disability Index (ODI), Short Form-36, and Zurich Claudication Questionnaire were prospectively recorded before surgery and at 6-week, 3-month, 6-month, and 1-year intervals after surgery. Prior to instrumentation, a bilateral total facetectomy and laminectomy at L4–5 or L3–4 was performed via a standard midline posterior approach. After decompression, the TOPS screws were inserted into four pedicles to achieve maximal purchase with triangulating bicortical trajectories. An appropriately sized TOPS arthroplasty implant was then applied.

The mean surgical time was 3.1 hours, and patients' clinical status improved significantly following treatment with the TOPS device. The mean ODI score decreased compared with baseline by 41% at 1 year, and the 100-mm VAS score declined by 76 mm over the same time period. Radiographic analysis showed that lumbar motion was maintained, disc height was preserved, and no evidence of screw loosening was found. No device malfunctions or migrations and no device-related adverse events were reported during the study.

Conclusions

The TOPS total posterior arthroplasty system represents a novel, dynamic, posterior arthroplasty device that provides multiaxial stability in flexion, extension, rotation, and lateral bending after total facetectomy and neural decompression. The surgical data indicate that it can be safely applied via a traditional approach with low surgical morbidity and excellent 1-year functional and radiographic outcomes in patients with degenerative spondylolisthesis accompanied by stenosis and back pain.

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Paul McAfee, Larry T. Khoo, Luiz Pimenta, Andy Capuccino, Domagoj Coric, Robert Hes, Bart Conix, Farbod Asgarzadie, Azmi Hamzaoglu, Yigal Mirofsky, and Yoram Anekstein

Object

Total disc replacement is an alternative to lumbar fusion, but patients with spinal stenosis, spondylolisthesis, and facet arthropathy are often excluded from this procedure because increased adjacent-segment motion can exacerbate dorsal spondylotic changes. In such cases of degenerative spondylolisthesis with stenosis, decompression and fusion remain the gold standard of treatment. To avoid attendant loss of motion at the treated segment, the TOPS system is a novel total posterior arthroplasty prosthesis that allows for an alternative dynamic, multiaxial, three-column stabilization and motion preservation. The purpose of this study is to report preliminary surgical data and clinical outcomes in patients treated with the TOPS lumbar total posterior arthroplasty system.

Methods

Twenty-nine patients were enrolled in a nonrandomized, multicenter, prospective pilot study outside the US. All patients had spinal stenosis and/or spondylolisthesis at L4–5 due to facet arthropathy. Radiographs and scores on outcome measures including the visual analog scale (VAS) for pain, Oswestry Disability Index (ODI), Short Form-36, and Zurich Claudication Questionnaire were prospectively recorded before surgery and at 6-week, 3-month, 6-month, and 1-year intervals after surgery. Prior to instrumentation, a bilateral total facetectomy and laminectomy at L4–5 or L3–4 was performed via a standard midline posterior approach. After decompression, the TOPS screws were inserted into four pedicles to achieve maximal purchase with triangulating bicortical trajectories. An appropriately sized TOPS arthroplasty implant was then applied.

The mean surgical time was 3.1 hours, and patients' clinical status improved significantly following treatment with the TOPS device. The mean ODI score decreased compared with baseline by 41% at 1 year, and the 100-mm VAS score declined by 76 mm over the same time period. Radiographic analysis showed that lumbar motion was maintained, disc height was preserved, and no evidence of screw loosening was found. No device malfunctions or migrations and no device-related adverse events were reported during the study.

Conclusions

The TOPS total posterior arthroplasty system represents a novel, dynamic, posterior arthroplasty device that provides multiaxial stability in flexion, extension, rotation, and lateral bending after total facetectomy and neural decompression. The surgical data indicate that it can be safely applied via a traditional approach with low surgical morbidity and excellent 1-year functional and radiographic outcomes in patients with degenerative spondylolisthesis accompanied by stenosis and back pain.

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Domagoj Coric, Ahmad Nassr, Paul K. Kim, William C. Welch, Stephen Robbins, Steven DeLuca, Donald Whiting, Ali Chahlavi, Stephen M. Pirris, Michael W. Groff, John H. Chi, Jason H. Huang, Roland Kent, Robert G. Whitmore, Scott A. Meyer, Paul M. Arnold, Ashvin I. Patel, R. Douglas Orr, Ajit Krishnaney, Peggy Boltes, Yoram Anekstein, and Michael P. Steinmetz

OBJECTIVE

The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial.

METHODS

The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory.

RESULTS

A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4–5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°).

CONCLUSIONS

This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.