Progression of adjacent-level degeneration and disease 7 years after lumbar total disc replacement, a post hoc analysis of 7-year data from a prospective clinical trial — The International Society for the Study of the Lumbar Spine
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  2. Special Poster Session 1D. INTERVERTEBRAL DISCS AND MODIC CHANGE
  3. Progression of adjacent-level degeneration and disease 7 years after lumbar total disc replacement, a post hoc analysis of 7-year data from a prospective clinical trial

Progression of adjacent-level degeneration and disease 7 years after lumbar total disc replacement, a post hoc analysis of 7-year data from a prospective clinical trial (#120)

Anton Jorgensen 1 , Dom Coric 2 , Peter Derman 3 , Ernest Braxton 4 , Kris Radcliff 5 , Glenn Buttermann 6 , Aaron Situ 7 , Nicole Ferko 7 , Jack Zigler 3
  1. Ortho San Antonio, San Antonio, Tx
  2. Carolina Neurosurgery and Spine Associates, Charlotte, NC
  3. Texas Back Institute, Plano, Tx
  4. Vail Health Vail Summit Orthopaedics and Neurosurgery, Vail, CO
  5. Rothman Orthopedic Institute, Philadelphia, PA
  6. Midwest Spine & Brain Institute, Stillwater, MN
  7. CRG-EVERSANA Canada , Burlington, ON, Canada

Objectives: To understand the progression of radiographic adjacent-level degeneration (ALDeg) seven years after lumbar TDR and the relationship of these changes with ROM and symptomatic adjacent-level disease (ALDis) using the seven-year follow-up data from the prospective, multicenter activL FDA IDE randomized controlled trial.

Methods: Patients with single-level, symptomatic lumbar disc degeneration who were unresponsive to ≥6 months of nonoperative care, received activL or ProDisc-L, and had radiographs available were analyzed for the incidence for ALDeg, incidence of ALDis, and progression of ALDeg (ΔALDeg). ALDeg presence was determined using a modified, 4-point, Kellgren-Lawrence scale. ALDis was defined as the need for reoperation at the segment adjacent to the index segment. The possible relationship between ROM and ΔALDeg was also investigated.

Results: At baseline, 16% of patients had ALDeg. By seven-year follow-up, this increased to 33%, with 80% showing no ΔALDeg. More patients experienced severe ALDeg by seven-year follow-up. Severity of ΔALDeg by seven years was mostly mild (76%) or moderate (21%); 3.4% of ΔALDeg was severe. Incidence of ALDis was identified in 4 patients through seven-year follow-up. Three patients received fusion at an adjacent level and one patient underwent fusion at the index and adjacent levels to treat stenosis at both levels along with symptomatic disc degeneration at the adjacent level. Improvement in ROM ranged from 0° at baseline to 16.4° at seven-year follow-up. For each minimal degree in ROM gained at the TDR level, there was a consistent decrease in the percent of patients with ΔALDeg. In patients having any improvement in ROM at the TDR level, 16.9% had ΔALDeg, whereas in patients with a ≥10° change or more in ROM (ie, ≥11°, ≥12°, etc.), 0% of patients had ΔALDeg (Figure).

Conclusions: Results of this post hoc analysis of seven-year data from the activL trial confirm that the rates of ALDeg, ALDeg progression, and clinical ALDis after TDR are relatively low over the long-term. Improvement in ROM may be associated with reduced ΔALDeg.

 

 

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