10-year prediction of adjacent-level degeneration and disease after lumbar total disc replacement and fusion: 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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  3. 10-year prediction of adjacent-level degeneration and disease after lumbar total disc replacement and fusion: A post hoc analysis of 7-year data from a prospective clinical trial

10-year prediction of adjacent-level degeneration and disease after lumbar total disc replacement and fusion: A post hoc analysis of 7-year data from a prospective clinical trial (#48)

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 estimate the probability of adjacent-level degeneration (ALDeg) and adjacent-level disease (ALDis), and progression of ALDeg (ΔALDeg) beyond 7 years after TDR and to compare ΔALDeg between TDR and fusion using the final, 7-year follow-up data from the prospective activL IDE trial.

Methods: Patients with single-level, symptomatic lumbar disc degeneration who were unresponsive to at least 6 months of nonoperative care who received activL or ProDisc-L and had radiographs available were analyzed for the incidence for ALDeg, incidence of ALDis, and progression of ALDeg (ΔALDeg). Prediction of the probability of ALDeg, ALDis, and ΔALDeg with TDR to 10 years was conducted using logistic regression modelling. To predict the ΔALDeg with fusion, an unanchored MAIC was conducted to mitigate differences between the TDR and fusion patient cohorts and derive a five-year odds ratio (OR) that was applied. A sensitivity analysis using an unadjusted TDR cohort and five-year OR published by Zigler et al., 2018.

Results: The predicted probability of ALDeg after lumbar TDR was 18.8% by one year, 27.2% by five years, 35.0% by seven years, and 53.9% by 10 years. In contrast, the predicted probability of clinical ALDis was 4.2% by 10 years. These probabilities were similar to those observed in the activL trial during the seven-year follow-up. After matching and adjusting, TDR had significantly lower odds of ΔALDeg than fusion at five-years (OR 0.32 ;95% CI, 0.13-0.72). The probability of ΔALDeg was predicted to be lower with TDR than with fusion to 10 years (TDR vs. fusion: 1 year, 3.0% vs. 9.1%; 5 years, 11.3% vs. 29.6%; 7 years, 21.3% vs. 47.0%; 10 years, 41.4% vs. 70.0%) (Figure). Similar results were observed in sensitivity analysis (TDR vs. fusion: 1 year, 2.0% vs. 6.8%; 5 years, 10.4% vs. 29.3%; 7 years, 21.1% vs. 48.9%; 10 years, 43.2% vs. 73.1%).

Conclusions: Predicted probability of ALDeg and ALDis to 10 years is low with TDR. Progression of ALDeg is anticipated to be substantially lower with TDR than with fusion over 10 years.

 

6193095be40f2-10-year+ALDeg+progression_Figure.PNG

  1. Zigler JE, Glenn J, Delamarter RB (2012) Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. J Neurosurg Spine 17 (6): 504-511.
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