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

Abstract

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.

Return to work after sick leave due to musculoskeletal disorder or injury: a longitudinal study conducted in Brazil

“…Regarding the influence of sex on the RTW, studies have yielded divergent results. Some have reported longer time off work for both men [ 7 ] and women [ 5 , 6 ]. Marital status at the time of the study is also a characteristic for which there is no consensus in the literature regarding its impact on the RTW.…”

“…Previous studies have consistently shown that the prognosis for returning to work after a disability episode due to musculoskeletal disorders is worse for workers in manual activities [ 5 , 6 , 9 – 11 ]. This can be attributed to the higher physical and biomechanical demands faced by manual workers (blue-collar workers) compared to those in administrative occupations (white-collar workers), as well as lower levels of education and remuneration [ 21 ].…”

“…Recent longitudinal studies conducted in several northern-hemisphere developed countries identified factors influencing the rate of return to work (RTW) in individuals with MSDI. These factors include: sociodemographic characteristics (such as sex [ 5 – 7 ], age [ 5 , 7 , 8 ], marital status [ 7 ], and education level [ 5 , 7 , 9 ]), working conditions (such as physical exertion [ 5 , 6 , 10 , 11 ], length of absence [ 12 ], social support [ 8 , 11 ], and self-efficacy [ 8 , 11 , 13 , 14 ]) and clinical characteristics (such as site of injury [ 5 ], pain intensity [ 5 , 11 ], comorbidities [ 7 , 8 , 12 ], and treatment used [ 6 , 11 ]).…”

Healthcare utilization trends in lumbar disc replacement: population-based administrative data

“…Moreover, spondylolisthesis patients undergoing lumbar fusion revisions have been shown to have 3.4 times greater odds of achieving clinical improvement after surgery ( 9 ). Therefore, there is evidence that spondylolisthesis is related both to the type of surgery a patient receives and post-operative outcomes and may have confounded the observed relationships in the study conducted by Upfill-Brown et al Other variables associated with spinal surgery outcomes not captured in the study included pre-operative physical disability and the type of surgical approach used (anterior, lateral or posterior) ( 10 , 11 ). However, it is unclear whether these patient and surgical characteristics are considered by surgeons when recommending a surgery, since most studies evaluating lumbar fusion and lumbar disc replacement have been randomized controlled trials (where patients are allocated to a surgery type by investigators).…”

Cervical and Lumbar Disk Replacement in Athletes: Is It Safe to Return to Play? A Systematic Review of the Scientific Literature and Lay Press

“…Total disk replacements have shown equivalence in safety and effectiveness to fusions in both the cervical 1-4 and lumbar regions. 5-10 Select studies have demonstrated superior outcomes to their fusion alternatives, with better disease-specific outcomes, 3 lower rates of adjacent segment disease, 2 and higher preservation of mobility. 8 However, studies, to date, are limited to the general population, and literature on return to play (RTP) after TDR in athletes remains sparse.…”