Predictors of long-term clinical outcomes in adult patients after lumbar total disc replacement: development and validation of a prediction model

Domagoj Coric MD1, Jack Zigler MD2, Peter Derman MD, MBA2, Ernest Braxton MD, MBA3, Aaron Situ MSc, MQF4, and Leena Patel PhD4
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  • 1 Atrium Musculoskeletal Institute, Spine Division, Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina;
  • | 2 Department of Spinal Surgery, Texas Back Institute, Plano, Texas;
  • | 3 Department of Neurological Surgery, Vail Health Vail-Summit Orthopaedics and Neurosurgery, Vail, Colorado; and
  • | 4 Value & Evidence, EVERSANA Life Science Services LLC, Burlington, Ontario, Canada
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OBJECTIVE

Long-term outcomes of single-level lumbar arthroplasty are understood to be very good, with the most recent Investigational Device Exemption (IDE) trial showing a < 5% reoperation rate at the close of the 7-year study. This post hoc analysis was conducted to determine whether specific patients from the activL IDE data set had better outcomes than the mean good outcome of the IDE trial, as well as to identify contributing factors that could be optimized in real-world use.

METHODS

Univariable and multivariable logistic regression models were developed using the randomized patient set (n = 283) from the activL trial and used to identify predictive factors and to derive risk equations. The models were internally validated using the randomized patient set and externally validated using the nonrandomized patient set (n = 52) from the activL trial. Predictive power was assessed using area under the receiver operating characteristic curve analysis.

RESULTS

Two factors were significantly associated with achievement of better than the mean outcomes at 7 years. Randomization to receive the activL device was positively associated with better than the mean visual analog scale (VAS)–back pain and Oswestry Disability Index (ODI) scores, whereas preoperative narcotics use was negatively associated with better than the mean ODI score. Preoperative narcotics use was also negatively associated with return to unrestricted full-time work. Other preoperative factors associated with positive outcomes included unrestricted full-time work, working manual labor after index back injury, and decreasing disc height. Older age, greater VAS–leg pain score, greater ODI score, female sex, and working manual labor before back injury were identified as preoperative factors associated with negative outcomes. Preoperative BMI, VAS–back pain score, back pain duration ≥ 1 year, SF-36 physical component summary score, and recreational activity had no effect on outcomes.

CONCLUSIONS

Lumbar total disc replacement for symptomatic single-level lumbar degenerative disc disease is a well-established option for improving long-term patient outcomes. Discontinuing narcotics use may further improve patient outcomes, as this analysis identified associations between no preoperative narcotics use and better ODI score relative to the mean score of the activL trial at 7 years and increased likelihood of return to work within 7 years. Other preoperative factors that may further improve outcomes included unrestricted full-time work, working manual labor despite back injury, sedentary work status before back injury, and randomization to receive the activL device. Tailoring patient care before total disc replacement may further improve patient outcomes.

ABBREVIATIONS

AUC = area under the receiver operating characteristic curve; DDD = degenerative disc disease; FDA = Food and Drug Administration; IDE = Investigational Device Exemption; ODI = Oswestry Disability Index; PCS = physical component summary; ROM = range of motion; SAE = serious adverse event; TDR = total disc replacement; VAS = visual analog scale.

Supplementary Materials

    • Appendices 1–3 (PDF 584 KB)

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