Assessment of Lumbar Motion and Patient Reported Outcomes after Decompression and use of Paraspinous Tension Band for Degenerative Spondylolisthesis: Results from 24-month FDA Study — The International Society for the Study of the Lumbar Spine
  1. Schedule
  2. SESSION #3 - SPONDYLOLISTHESIS
  3. Assessment of Lumbar Motion and Patient Reported Outcomes after Decompression and use of Paraspinous Tension Band for Degenerative Spondylolisthesis: Results from 24-month FDA Study

Assessment of Lumbar Motion and Patient Reported Outcomes after Decompression and use of Paraspinous Tension Band for Degenerative Spondylolisthesis: Results from 24-month FDA Study (#13)

Michael P Stauff 1 , Rick C Sasso 2 , Serena Hu 3 , Alan T Villavicencio 4 , Tim Yoon 5 , William Lavelle 6 , Kee D Kim 7 , Sandhu Harvinder 8 , Hyun Bae 9 , Harel Deutsch 10 , Khalid Sethi 11 , Jeffrey S Fischgrund 12 , Mick Perez-Cruet 12 , Elizabeth Yu 13 , Sigurd H Berven 14 , Matthew Mermer 15 , Reginald J Davis 16 , Ravi S Bains 17 , Calvin C Kuo 17 , W Zach Ray 18 , Todd F Alamin 3 , Louie Fielding 19 , William C Welch 20
  1. UMass Memorial Medical Center/University of Massachusetts Medical School, Worcester, MASSACHUSETTS, United States
  2. Indiana Spine Group, Carmel, Indiana, United States
  3. Stanford University, Stanford, CA
  4. Boulder Neurosurgical Associates, Boulder, CO
  5. Emory University, Atlanta, GA
  6. SUNY Upstate Medical University, Syracuse, NY
  7. University of California Davis, Sacramento, CA
  8. Hospital for Special Surgery, New York, NY
  9. Cedars Sinai, Los Angeles, CA
  10. Rush University, Chicago, IL
  11. UHS Neurosurgery, Johnson City, NY
  12. Beaumont Hospital, Royal Oak, MI
  13. Ohio State University Wexner Medical Center, Columbus, OH
  14. University of California, San Francisco, San Francisco, CA
  15. Kaiser Permanente, Roseville, CA
  16. BioSpine Institute, Tampa, FL
  17. Kaisar Permanente, Oakland, CA
  18. Washington University, St Louis, MO
  19. Empirical Spine, San Carlos, CA
  20. University of Pennsylvania, Philadelphia, PA

Introduction: Durable outcome for degenerative spondylolisthesis (DS) often requires decompression and fusion.  Fusion, however, places greater stress at adjacent levels that can lead to progressive adjacent segment disease. A novel interspinous tension band is proposed for segmental stabilization after decompression for DS, as an alternative to fusion.  An FDA IDE study (NCT03115983) compares decompression and stabilization with the paraspinous tension band (PTB, treatment group) to decompression and instrumented fusion (control group) for symptomatic DS.

Methods: Prospectively enrolled IDE study subjects with 24 months postoperative radiographic follow-up were included in this analysis. X-rays obtained during the follow-up period for both the treatment (n=75) and control (n=52) groups were reviewed by an independent Core Laboratory for flexion/extension range of motion (ROM) and translation at the index, supradjacent and subjacent levels.  Enrolled patients reported clinical outcomes (VAS back/leg, ODI) at baseline, 6 weeks, 3, 6, 12 months, and 24 months.  Clinical success was defined as an ODI improvement of 15 points.  Paired t-test was used to assess differences in outcomes. 

Results: For the PTB group, pre-op to 24-month post-operative ROM was reduced 33% (p<0.01) and translation was reduced 29% (p<0.01). The fusion group as expected showed a significantly greater decrease in ROM (68%, p<0.01) and translation (77%, p<0.01) at the index level.  Neither group had a statistically significant change in ROM/translation at supradjacent and subjacent levels. When assessing lumbar segmental range of motion at 24 months, adjacent segments accounted for 73% of motion in the treatment group and 87% in the control group.  The patient reported outcomes were strong in both the PTB (mean VAS leg improvement 56.1, mean VAS back improvement 47.1, mean ODI improvement 39.4) and fusion (mean VAS leg improvement 51.0, mean VAS back improvement 57.4, mean ODI improvement 31.9) patients with no significant difference between groups.  Clinical success, defined by ODI improvement of 15 points, was achieved in 88% in the PTB cohort and 76% in the fusion cohort, with no significant difference between groups.

Conclusion: Unlike fusion, PTB for DS maintained both stability and the anatomic range of motion and translation at the index levels out to 24 months.  This maintained motion could lead to less progressive adjacent segment disease when DS is treated with PTB as opposed to fusion.  The patient-reported clinical outcomes at 24 months post-operatively were similarly strong for both groups.  These results should be confirmed with a longer follow-up including clinical outcomes in propensity score-matched patients.

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