80. FDA trial of decompression and paraspinous tension band for degenerative spondylolisthesis: 12 months follow-up in 93 subjects

• Published in: The spine journal Vol. 20; no. 9; p. S39
• Main Authors: Sasso, Rick C., Cheng, Ivan, Lavelle, William F., Yoon, S. Tim, Villavicencio, Alan T., Kim, Kee D., Bains, Ravi S., Kuo, Calvin C., Bae, Hyun W., Yu, Elizabeth, Alamin, Todd F., Fielding, Louie C., Fischgrund, Jeffrey, Deutsch, Harel, Sethi, Khalid A., Sandhu, Harvinder S., Stauff, Michael, Davis, Reginald J., Crandall, Dennis G., Welch, William C.
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.09.2020
• ISSN: 1529-9430; 1878-1632
• DOI: 10.1016/j.spinee.2020.05.183

Degenerative spondylolisthesis (DS) with lumbar spinal stenosis (LSS) is commonly treated with decompression and fusion. The LimiFlex paraspinous tension band (PTB) is an investigational stabilization device for patients with DS and LSS. The purpose of this study is to assess the operative safety and short-term outcomes of decompression and PTB compared to transforaminal lumbar interbody fusion (TLIF) for patients with DS and LSS. Multicenter prospective concurrently controlled study. Patients undergoing treatment (decompression and PTB or TLIF stabilization) of Grade I Meyerding lumbar degenerative spondylolisthesis. Patient demographics, patient reported ODI, VAS leg, and VAS back, and procedural, discharge, and short-term clinical outcomes up to 12 months postoperatively. Patients with single-level Grade 1 DS with LSS were enrolled in the multicenter, FDA-IDE study comparing decompression with PTB and decompression with TLIF. Perioperative and patient-reported clinical outcomes were recorded at baseline and 6-week, 3-month, 6-month and 12-month follow-up. All patients who reached 12-month follow-up were included in this interim analysis. Summary statistics are reported, as well as paired t-tests to assess within-group changes. A total of 93 patients (58 PTB, 35 TLIF) reached 12-month follow-up. Characteristics of PTB vs TLIF groups, respectively were: age 64.9±8.1, 64.1±7.4 yrs; BMI 28.7±4.9, 29.2±5.8; current smokers 2%, 3%. Perioperative outcomes for PTB vs TLIF were: operative time 110±29, 172±58 minutes; EBL 42±26, 241±155 mL; LOS 0.6±1.5, 3.3±1.7 nights. A significant reduction from baseline to 12 months for mean VAS-leg/hip (79.4±10.4 to 19.8±27.5), VAS-back (67.5±22.9 to 17.7±25.1) and ODI (53.1±13.1 to 12.6±16.0) was reported for PTB patients (all p<0.01) with 91% achieving 15-point ODI improvement. TLIF patients demonstrated similar improvements for VAS-leg (79.6±13.7 to 29.3±29.2), VAS-back (73.3±18.3 to 20.5±24.1), and ODI (52.4±12.6 to 17.2±18.2) (all p<0.01), with 83% achieving 15-point ODI improvement. During the 12-month follow-up, 2 PTB (3.4%) and 3 TLIF (8.6%) subjects had reoperations. These preliminary results suggest that decompression with PTB stabilization for spondylolisthesis can be accomplished safely without a significant increase in complications during the perioperative and short-term follow-up periods. Similarly, statistically significant improvements in patient-reported outcomes were demonstrated in each group. As groups were not propensity matched, further investigation to include quantitative comparison between groups with long-term follow-up is needed to confirm these results. LimiFlex Paraspinous Tension Band (Investigational/Not approved).