BACKGROUND CONTEXT

Prior studies have demonstrated the superiority of decompression and fusion over decompression alone for the treatment of lumbar degenerative spondylolisthesis with spinal stenosis. More recent studies have investigated whether nonfusion stabilization could provide durable clinical improvement after decompression and fusion.

PURPOSE

To examine the clinical safety and effectiveness of decompression and implantation of a novel flexion restricting paraspinous tension band (PTB) for patients with degenerative spondylolisthesis.

STUDY DESIGN

A prospective clinical study.

PATIENT SAMPLE

Forty-one patients (7 men and 34 women) aged 45 to 83 years (68.2 ± 9.0) were recruited with symptomatic spinal stenosis and Meyerding Grade 1 or 2 degenerative spondylolisthesis at L3-L4 (8) or L4-L5 (33).

OUTCOME MEASURES

Self-reported measures included visual analog scale (VAS) for leg, back, and hip pain and the Oswestry Disability Index (ODI). Physiologic measures included quantitative and qualitative radiographic analysis performed by an independent core laboratory.

METHODS

Patients with lumbar degenerative spondylolisthesis and stenosis were prospectively enrolled at four European spine centers with independent monitoring of data. Clinical and radiographic outcome data collected preoperatively were compared with data collected at 3, 6, 12, and 24 months after surgery. This study was sponsored by the PTB manufacturer (Simpirica Spine, Inc., San Carlos, CA, USA), including institutional research support grants to the participating centers totaling approximately US $172,000.

RESULTS

Statistically significant improvements and clinically important effect sizes were seen for all pain and disability measurements. At 24 months follow-up, ODI scores were reduced by an average of 25.4 points (59%) and maximum leg pain on VAS by 48.1 mm (65%). Back pain VAS scores improved from 54.1 by an average of 28.5 points (53%). There was one postoperative wound infection (2.4%) and an overall reoperation rate of 12%. Eighty-two percent patients available for 24 months follow-up with a PTB in situ had a reduction in ODI of greater than 15 points and 74% had a reduction in maximum leg pain VAS of greater than 20 mm. According to Odom criteria, most of these patients (82%) had an excellent or good outcome with all except one patient satisfied with surgery. As measured by the independent core laboratory, there was no significant increase in spondylolisthesis, segmental flexion-extension range of motion, or translation and no loss of lordosis in the patients with PTB at the 2 years follow-up.

CONCLUSIONS

Patients with degenerative spondylolisthesis and spinal stenosis treated with decompression and PTB demonstrated no progressive instability at 2 years follow-up. Excellent/good outcomes and significant improvements in patient-reported pain and disability scores were still observed at 2 years, with no evidence of implant failure or migration. Further study of this treatment method is warranted to validate these findings.