Abstract
Background
Patients’ expectations influence their decisions to undergo surgery for scoliosis, and fulfillment of expectations is an important patient-centered outcome.
Questions/Purposes
In a 2-year cohort study, we compared the proportion of expectations fulfilled based on the number of vertebrae involved in surgery between adult lumbar scoliosis patients and controls with other degenerative conditions.
Methods
Patients pre-operatively completed a valid lumbar surgery expectations survey addressing expected improvements for symptoms, function, and psychosocial well-being (scores from 0 to 100; higher score indicates more expectations). Two years post-operatively, the patients completed another survey, this one recording how much improvement they actually experienced; fulfillment was defined as a proportion (i.e., received improvement/expected improvement). The range was 0 (none fulfilled) to > 1 (expectations surpassed). We further analyzed data according to the number of vertebrae involved in the surgery.
Results:
We included 42 scoliosis patients and 134 controls with similar mean ages (66 vs 64 years, respectively) and pre-operative expectations survey scores (72 vs 70, respectively). When we stratified by < 3 or ≥ 3 vertebrae, we found that the proportion of expectations fulfilled differed for scoliosis patients but not for controls. In multivariable analysis, lower proportion of expectations fulfilled was associated with greater pre-operative expectations, less improvement in pre- to post-operative disability, and the composite interaction of scoliosis and number of vertebrae.
Conclusions
Compared with controls, scoliosis patients who required surgery to a greater number of vertebrae were more likely to have unfulfilled expectations 2 years post-operatively. Our findings support the importance of addressing expectations pre-operatively with all patients, especially those with scoliosis who require surgery to ≥ 3 vertebrae.
Electronic supplementary material
The online version of this article (10.1007/s11420-020-09812-1) contains supplementary material, which is available to authorized users.
Keywords: expectations, expectations fulfilled, lumbar scoliosis, expectations unfulfilled
Introduction
Patients with symptomatic adult lumbar scoliosis often attempt multiple conservative therapies before seeking surgery [3]. When orthopedic conditions indicate surgery, patients will ultimately decide to undergo complex and potentially risky procedures because they expect to alleviate pain, restore their ability to fulfill desired roles and lifestyles, and thwart the progression of scoliosis [18, 22]. Patients also expect that surgery will improve psychological well-being and lessen the control their spine has on daily life [9]. In order to optimize outcomes, it is essential to acknowledge these diverse expectations and ensure that they are not unrealistic [16]. Unrealistically high expectations may produce patients to poor outcomes if they become discouraged with time to recuperate, do not fully participate in physical therapy, or do not adhere to necessary precautions to support post-operative healing. Expectations that are too low can also predispose to poor outcomes when patients lack motivation to participate in therapy or adopt long-term lifestyle modifications that minimize disease progression. Understanding the characteristics associated with unreasonable expectations may help physicians to foster realistic expectations in their patients.
Traditional outcomes of scoliosis surgery include alignment, fusion, and patients’ self-reported symptoms, function, and appearance. These are measured by valid and reliable questionnaires such as the Oswestry Disability Index (ODI), the Scoliosis Research Society-22 Questionnaire (SRS-22), and the Roland-Morris Disability Questionnaire (RMDQ) [2, 3, 6, 7, 18, 19, 22, 23, 25]. Fulfillment of expectations is a novel outcome that adds new dimensions to the assessment of results [11, 16]. Specifically, if expectations are identified pre-operatively and then assessed for fulfillment post-operatively, this constitutes an independent and prospective appraisal of the impact of surgery from the patients’ point of view. In addition, ascertaining which expectations are unfulfilled helps to establish why and in what ways surgery was unsuccessful. Thus, assessing fulfillment of expectations is a truly patient-centered outcome that provides a new method to assess the effectiveness and potential value of surgery to the patient [18, 22].
In a large prospective study of patients with diverse lumbar diagnoses including adult scoliosis, we previously developed and validated an expectations survey to measure patients’ expectations for physical and psychological improvement from lumbar surgery [9]. Based on this survey, we found that greater pre-operative expectations and fulfillment of expectations 2 years after surgery were associated with various demographic and clinical characteristics [10, 12]. This report is a sub-analysis from that study, designed to compare fulfillment of expectations 2 years after surgery between two cohorts: patients with adult lumbar scoliosis and age-matched patients with other lumbar diagnoses. This analysis accounted for the number of vertebrae involved as well as previous and subsequent surgery and was therefore particularly relevant to scoliosis patients.
Methods
This study was approved by our Institutional Review Board, and all patients provided written informed consent. From February 2010 to August 2012, 420 consecutive patients were enrolled in the study; from April 2012 to September 2014, 366 of these had follow-up telephone calls. Of those with follow-ups, 42 had a primary diagnosis of scoliosis (mainly de novo adult degenerative subtype), and 134 were within the desired age range and had other primary degenerative conditions (disc disease 24, stenosis 66, spondylolisthesis 44) and comprised the comparison (control) group [1, 8]. Pain relief was the main reason for surgery in both groups. The remaining patients were not included in this analysis because they were not within the desired age range (62), had inflammatory spine conditions (19), had device issues or non-union (21), had a diagnosis of acute herniated nucleus pulposus (80), or had other conditions (8).
Pre-operative patient information was collected from consecutive adult patients scheduled for non-urgent lumbar surgery by one of four high-volume spine-specialty trained surgeons; patients were approached during routine pre-operative assessments several days before surgery. They were enrolled at that time and completed the following surveys. The Lumbar Spine Surgery Expectations Survey is a valid and reliable survey derived previously from patients who had various lumbar diagnoses, including adult degenerative lumbar scoliosis [9]. Patients’ responses to open-ended questions reflected a spectrum of expectations (samples for scoliosis patients are in Table 1). Based on qualitative analysis, a 20-item survey was developed and included expectations for symptom relief, functional status, and psychological well-being (Table 2). For each item, patients were asked how much improvement they expected and responded with one of the following options: “complete” (4 points), “a lot” (3 points), “a moderate amount” (2 points), “a little” (1 point), or “I do not have this expectation/does not apply to me” (0 point). Points were summed to generate an overall score, which is transformed to range from 0 to 100; higher scores represent greater expectations. Four domains were discerned based on factor analysis: physical activities (6 items); daily function (4 items); psychosocial well-being (4 items); and skeletal function (2 items). Two items were not included, one about pain because it did not map to any specific domain and one about employment because it was not applicable to most patients. Patients also completed standard questionnaires for symptoms of depression and anxiety, ratings of back and leg pain, and the modified Oswestry Disability Index (ODI) [6, 7, 20, 24]. Patients also were asked about duration of symptoms, use of medications, and prior spine surgery.
Table 1.
Answers to open-ended questions: “What do you expect as a result of your spine surgery? After you are healed, what will be different?”
| “I expect after this surgery I will be well overall and will be able to do the things I need to do, like drive to visit my daughter and basically get my life back to normal.” | |
| “I need the surgery to make me walk straight and also stand in line while maintaining my balance.” | |
| “This surgery will bring happiness and get rid of depression.” | |
| “No more pain killers and no more pain at the same time.” | |
| “I expect the surgery will help me go back to work and not worry about falling.” | |
| “I expect less pain, both back and leg pain; I expect to get around with minimal pain and not need a cane.” | |
| “I miss just walking; walking for anything like going window shopping, exercising, going to the beach, doing things with my granddaughter. I should be able to do these things after the surgery.” | |
| “I expect to be able to run errands, play tennis, golf, swim, and ride my bike.” | |
| “From this surgery I will be able to enjoy life again.” | |
| “I expect to do things around my house, like go up and down the stairs, stand longer to cook, take a shower, lift anything, and just stand differently.” | |
| “I expect to sleep in a bed and not a recliner, to resume sex, and walk longer distances when I have to.” |
Table 2.
Proportion of patients having each expectation according to diagnosis
| Expectation | Percent of patients having this expectation | |
|---|---|---|
| Adult scoliosis (n=42) (%) | Degenerative condition (n=134) (%) | |
| Relieve pain | 100 | 99 |
| Relieve symptoms that interfere with sleepa | 88 | 78 |
| Improve ability to walk more than several blocksb | 100 | 97 |
| Improve ability to sit more than half an houra | 91 | 73* |
| Improve ability to stand more than half an hourb | 100 | 98 |
| Regain strength in legsd | 76 | 87 |
| Improve balanced | 76 | 78 |
| Improve ability to up and down stairsb | 98 | 87* |
| Improve ability to manage personal carea | 79 | 65 |
| Improve ability to drivea | 76 | 58* |
| Remove need for pain medicationsa | 100 | 100 |
| Improve ability to interact with othersc | 86 | 90 |
| Improve sexual activitya | 69 | 66 |
| Improve ability to perform daily activitiesc | 93 | 94 |
| Improve ability to exercise for general healthb | 98 | 96 |
| Remove restrictions in activities (be more mobile)c | 93 | 93 |
| If currently employed…fulfill job responsibilities | 26 | 31 |
| If currently work-disabled due to spine…go back to work | 12 | 10 |
| Reduce emotional stress or sad feelingsc | 76 | 78 |
| Stop spine condition from getting worseb | 98 | 97 |
| Remove control spine has on my lifeb | 100 | 96 |
*p ≤ .05
aPersonal activities
bDaily function
cPsychosocial well-being
dSkeletal function
Primary and secondary diagnoses were assigned to each patient at the time of surgery by a senior spine surgeon according to a comprehensive protocol of clinical history, physical examination, and imaging studies. Patients with a primary diagnosis of adult lumbar scoliosis were assembled as one diagnostic group, and their age range was ascertained. Patients who were in the same age range but whose primary diagnosis was another degenerative condition (i.e. degenerative disc disease, arthritic spinal stenosis, and degenerative spondylolisthesis) were assembled as a control group.
Patient charts were studied to determine surgical invasiveness. This was ascertained according to a standard index that assigns points for decompression, fusion, instrumentation, and approach at each level; all points are summed to reflect the complexity of surgery [17]. Comorbidity was also rated according to a standard index [5].
Approximately 2 years after surgery, patients were contacted by telephone and asked to complete the follow-up version of the expectations survey, which asks how much each item on the pre-operative survey had improved for them. Responses included “complete,” “a lot,” “a moderate amount,” “a little,” and “no improvement.” A proportion was then calculated (as described below) to represent the fulfillment of expectations. This proportion has been shown to be a valid outcome based on comparison with several global measures of satisfaction with surgery [11]. Patients also reported current back and leg pain and any subsequent surgery.
Data Analysis
Demographic and clinical characteristics were compared between groups with χ-square tests and t tests. The frequency of endorsement of each item on the expectations survey and the overall score was calculated and compared between groups. The proportion of expectations fulfilled was defined as the sum of points for improvement received (post-operatively) divided by the sum of points for improvement expected (pre-operatively). The proportion ranges from 0 (no expectations fulfilled) to > 1 (expectations surpassed). Groups were stratified based on the number of vertebrae involved—i.e., < 3 (fewer vertebrae) or ≥ 3 (more vertebrae)—and we then compared pre- and post-operative values in disability and back/leg pain, surgical complexity, whether subsequent surgery occurred, and the proportion of expectations fulfilled. To ascertain what variables were associated with fewer fulfilled expectations, bivariate and multivariable linear regression analyses were carried out with the proportion of expectations fulfilled as the dependent variable. The independent variables were the demographic and clinical characteristics that differed between diagnostic groups or within diagnostic groups based on number of vertebrae involved. The analyses included an interaction term to assess the particular effect of number of vertebrae within diagnostic group. Variables with p ≤ 0.05 were retained in the multivariable model. To ascertain what types of expectations were more likely to be unfilled, other analyses considered unfulfilled expectations for each of the four domains of the expectations survey. For these analyses, the mean difference in pre- to post-operative points was calculated separately for each domain and compared within each diagnostic group based on number of vertebrae using t tests. All analyses were carried out in SAS Version 9.3 (Cary, NC, USA).
Results
The mean follow-up time was 2.1 years (range 1.9 to 2.6 for each group). Compared with controls, scoliosis patients were more likely to have had previous spine surgery, to be taking opioids, and to have more disability (i.e., higher ODI scores) (Table 3). They also had different surgical approaches and were more likely to have more than one surgical approach, to have surgery to ≥ 3 vertebrae, and to have more complex surgery (Table 4). They did not differ from controls in mean expectations survey score, but they were more likely to expect to be able to sit, to drive, and to go up and down stairs (Table 2).
Table 3.
Pre-operative demographic and clinical variables according to diagnosis
| Variable | Adult scoliosis (n = 42) | Degenerative condition* (n = 134) | p value |
|---|---|---|---|
| Age, years, mean ± SD | 66 ± 9 | 63 ± 8 | .10 |
| Women | 66% | 39% | .003 |
| College graduate | 42% | 63% | .03 |
| Working full-time | 17% | 29% | .16 |
| Has major medical comorbiditya | 26% | 38% | .22 |
| Positive screen for depressionb | 45% | 36% | .27 |
| More anxiety than population normsc | 67% | 52% | .10 |
| Body mass index (kilograms/m2) | 28 ± 5 | 29 ± 5 | .07 |
| Ever smoked | 55% | 41% | .17 |
| Duration of current spine symptoms > 12 months | 62% | 59% | .73 |
| Had prior spine surgery | 64% | 38% | .005 |
| Currently taking opioids | 55% | 34% | .03 |
| Severity of back paind | |||
| 0–6 | 46% | 33% | .16 |
| 7–10 | 55% | 67% | |
| Severity of leg paind,e | |||
| 0–6 | 43% | 55% | .16 |
| 7–10 | 57% | 45% | |
| Disability due to spine (mean ± SD)f | 59 ± 12 | 53 ± 14 | .02 |
| Expectations survey score (mean ± SD)g | 72 ± 19 | 70 ± 18 | .60 |
*Includes spinal stenosis, degenerative disc disease, degenerative spondylolisthesis
aBased on Charlson Comorbidity Index
bBased on Geriatric Depression Scale
cBased on Spielberger State-Trait Anxiety Inventory
dPossible range 0–10, higher is worse pain
eFor more affected leg
fBased on modified Oswestry Disability Index, possible score 0–100, higher is worse status
gBased on Lumbar Spine Surgery Expectations Survey, possible score 0–100, higher is greater expectations
Table 4.
Intra-operative features according to diagnosis and number of vertebrae involved
*Comparisons between adult scoliosis and degenerative condition groups
aBased on Surgical Invasiveness Index; points assigned for each category, maximum 10 points for each vertebral level, total score is sum of points from all levels
For the entire sample, the proportion of expectations fulfilled was .65 ± .39 (range 0 (no expectations fulfilled) to 1.64 (expectations surpassed)); this was similar for the scoliosis (0.60) and control groups (0.67). However, according to within-group comparisons by number of vertebrae, the proportion was higher for scoliosis patients with < 3 levels (0.81) compared with those with ≥ 3 levels (0.48), but was similar within the control group (Table 5). The within-patient changes in pre- to post-operative ODI scores and back/leg pain ratings also reflected improvement, but did not differ according to number of vertebrae or diagnosis.
Table 5.
Pre- to post-operative change in variables according to diagnosis and number of vertebrae involved
| Variable | Adult scoliosis | Degenerative condition | p value* | ||||
|---|---|---|---|---|---|---|---|
| < 3 vertebrae | ≥ 3 vertebrae | p value | < 3 vertebrae | ≥ 3 vertebrae | p value | ||
| Proportion of expectations fulfilled (mean ± SD)a | .81 ± .34 | .48 ± .43 | .01 | .71 ± .37 | .62 ± .37 | .16 | .30 |
| Improvement in disability (mean ± SD)b | 38 ± 18 | 27 ± 23 | .24 | 32 ± 22 | 22 ± 23 | .05 | .53 |
| Improvement in back pain (mean ± SD)c | 3.8 ± 3.4 | 2.9 ± 4.0 | .48 | 3.2 ± 4.0 | 3.4 ± 4.3 | .84 | .84 |
| Improvement in leg pain (mean ± SD)c | 4.4 ± 3.6 | 3.7 ± 3.9 | .57 | 3.9 ± 4.3 | 4.0 ± 4.3 | .90 | .96 |
| Had subsequent spine surgery during follow-up period | 29% | 33% | .76 | 20% | 19% | .95 | .10 |
*Comparisons between adult scoliosis and degenerative condition groups
aBased on [blinded] Lumbar Spine Surgery Expectations Survey, points for improvement received divided by points for improvement expected
bBased on modified Oswestry Disability Index, pre-operative minus post-operative score
cBased on pre-operative minus post-operative numerical rating
Overall, 10% of scoliosis cases and 4% of controls had a post-operative complication that required transfer to a higher level of care (p = 0.08); transfers were for hemodynamic monitoring and not for spine-related complications. At 2-year follow-up, 21% of scoliosis cases and 39% of controls had a dural tear (p = 0.04), and, according to self-report, 7% of cases and 7% of controls had an infection (p = 0.91); neither variable was associated with proportion of expectations fulfilled based on number of vertebrae involved. The re-operation rate during the 2-year follow-up was 32% for scoliosis cases and 20% for controls (p = 0.10).
In bivariate analyses, the proportion of expectations fulfilled was the dependent variable and independent variables were those that differed according to diagnosis or number of vertebral levels. An interaction term was included to ascertain whether number of vertebrae was more relevant for scoliosis patients. Variables that were associated at p ≤ 0.05 were entered into a multivariable model. Using backward step-wise elimination, the following variables were associated with a lower proportion (i.e., more unfulfilled expectations): more pre-operative expectations (i.e., greater expectations survey scores), less improvement in disability (i.e., less change in pre- to post-operative ODI score), and, finally, scoliosis with more vertebrae involved (Table 6).
Table 6.
Bivariate and multivariable associations with lower proportion of expectations fulfilled as dependent variable
| Variable | Bivariate | Multivariable | ||||
|---|---|---|---|---|---|---|
| Estimate | 95% CI* | p value | Estimate | 95% CI* | p value | |
| Older age | .34 | − .38, 1.07 | .35 | – | – | – |
| Women | .12 | − 11.8, 11.6 | .98 | – | – | – |
| Did not have prior surgery | .44 | − 11.3, 12.2 | .94 | – | – | – |
| Taking opioids | .72 | − 12.7, 11.2 | .91 | – | – | – |
| Greater expectations | .46 | .14, .78 | .005 | .71 | .39, 1.05 | < .0001 |
| No fusion performed | 2.61 | − 9.1, 14.3 | .66 | – | – | – |
| More than one approach | 13.2 | − 2.9, 29.2 | .11 | – | – | – |
| More surgical complexity | .54 | − .15, 1.23 | .12 | – | – | – |
| Less improvement in disability | .79 | .53, 1.05 | < .0001 | .91 | .66, 1.16 | < .0001 |
| Scoliosis | 7.19 | − 6.46, 20.8 | .30 | 7.23 | − 12.7, 27.2 | .47 |
| More vertebrae | 15.4 | 3.97, 25.9 | .009 | 9.1 | − 3.14, 21.3 | .14 |
| Scoliosis-more vertebrae | 20.6 | 4.67, 36.5 | .01 | 26.9 | .98, 52.8 | .04 |
| Had subsequent spine surgery during follow-up period | 9.66 | − 4.37, 23.7 | .18 | – | – | – |
*Confidence interval (should not cross 0)
Variables in italics are for variables included in the interaction term and their performance in the model if they were considered individually
To determine which expectations were more likely to be unfulfilled, additional analyses focused on domains of the expectations survey. The mean difference in pre- to post-operative points (reflecting amount of improvement expected vs received) was calculated for each domain and then compared within each diagnostic group based on number of vertebrae. The scoliosis group was more likely than the control group to have unfulfilled expectations for all domains if they had surgery on ≥ 3 vertebrae; the domains that were most likely to be unfulfilled were daily function and psychosocial well-being (Fig. 1).
Fig. 1.
Bar graph of unfulfilled expectations based on mean values for amount of improvement received vs amount of improvement expected for Expectation Survey domains according to diagnosis and number of vertebrae.
Discussion
In this prospective study of older adults undergoing lumbar spine surgery, we found that patients with scoliosis differed from controls with other degenerative conditions in terms of clinical and psychological variables. But despite a clinical condition that was often characterized by worse disability and more vertebrae involved than controls, we found that patients with scoliosis had high expectations of surgery, similar to controls. The proportion of expectations fulfilled after surgery, however, was markedly lower for scoliosis patients with the most vertebrae involved. This most likely indicates that in this sub-group, pre-operative expectations were too ambitious for the existing clinical scenario. The expectations most likely to be unfulfilled were improved daily function and psychosocial well-being.
Our study has several limitations. First, it was conducted at a single tertiary care institution with patients undergoing surgery by spine specialists and may not be representative of patients in other settings. Second, consecutive patients were enrolled without regard to diagnosis until the desired sample size was achieved. As such, this analysis does not have the requisite number of patients to make conclusions about potentially important covariates such as dural tear and infection, nor about severity for any diagnosis, such as Cobb angle for scoliosis. Third, we did not include detailed radiographic measurements of anatomic features that are associated with outcomes. Fourth, we did not know if the subsequent surgeries patients had were unplanned or anticipated at the time of enrollment in our study.
We previously showed that patients’ expectations of lumbar surgery are influenced by their surgeons’ perspectives, prior surgery, the media, social networks, and other physicians [15]. But patients with adult scoliosis may have developed certain characteristics that make it more challenging to understand their influences and expectations [4]. First, patients undergoing scoliosis surgery need to understand the surgeons’ explanation of what is being done (and not being done) for both their current and their future situation [4, 25]. Thus, their expectations may be swayed by short-term vs long-term perspectives [4]. Second, many scoliosis patients have had prior surgery and their current expectations are influenced by previous experience. While this may be beneficial, it can also lead to unrealistically high expectations (if previous results were remarkably good) or unnecessarily low expectations (if previous results came up short) [22, 23]. Third, although all degenerative conditions portend a chronic scenario, scoliosis patients likely come to learn and accept this sooner [25]. This may be advantageous if it leads to earlier adoption of healthy spine behaviors. However, it may also foster a self-image of inevitable and increasing disability and thus provoke dour expectations of what is to come. How all these general and scoliosis-specific issues affect expectations requires careful discussion with each patient [22].
We also found differences in several clinical and psychological variables between groups. Compared with controls, the scoliosis group was more likely to have symptoms of depression and anxiety, to smoke, to require opioids, and to report worse disability. Our results confirm findings from other studies (e.g. Spinal Deformity Study Group) that found that these variables more closely predicted worse ODI and SRS-22 outcomes than predicted by technical/surgical parameters [23]. However, our analysis did not include radiographic features that are known to be associated with patient-reported outcomes [21].
The age range of patients in our study was similar to another study that separated a large scoliosis sample into younger (18 to 45) and older adults (46 to 85) to assess predictors of outcomes of surgery [23]. This distinction is important because younger adults have different perspectives, experiences, and even anatomical spine features—and all of these will affect their expectations of surgery [18, 25].
Our prior studies focused on addressing expectations broadly in large samples of patients with diverse lumbar diagnoses [9–15]. These general assessments provided the landscape for this research. More diagnosis-specific analyses are now needed to uncover associations that are otherwise missed with general analyses. In our parent study, number of vertebrae was independently associated with the proportion of expectations fulfilled for acute and degenerative diagnoses, considered collectively [11]. This prompted us to look closely at the number of vertebrae in patients who were most likely to have surgery at more levels (i.e. scoliosis). Assessing the interaction between scoliosis and number of vertebrae permitted us to uncover that this composite variable was associated with outcomes. We dichotomized the sample at 3 vertebrae because the involvement of three or more vertebrae in the lumbar region likely indicates some clinically relevant deformity. Scoliosis involving the thoracic spine obviously would require a different expectations survey and different thresholds for number of vertebrae involved.
In conclusion, patients with adult lumbar scoliosis have high expectations of surgery that are comparable with those of controls with other degenerative conditions. Given the greater number of vertebrae typically involved for scoliosis patients, the need for more complex surgery, and the greater degree of disability, it may be that, for some, comparable expectations are unrealistic expectations. This is supported by the association between lower proportions of expectations fulfilled and greater number of vertebrae involved. This prospective study demonstrated that among scoliosis patients, greater pre-operative expectations, less pre- to post-operative improvement in disability, and more vertebrae involved were associated with a lower proportion of expectations fulfilled at 2 years. Our findings support addressing expectations pre-operatively with all patients, but particularly with scoliosis patients who require surgery to more vertebrae.
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Compliance with Ethical Standards
Conflict of Interest
Carol A. Mancuso, MD, and Roland B. Duculan, MD, declare that they have no conflict of interest. Frank P. Cammisa Jr., MD, reports institutional research support from Orthofix Medical Inc. (formerly Spinal Kinetics, Inc.), NuVasive, Inc., Mallinckrodt Pharmaceuticals, Centinel Spine, Inc. (fka Raymedica, LLC), Beatrice & Samuel A. Seaver Foundation, 4WEB Medical/4WEB, Inc., 7D Surgical, Inc., and Pfizer, Inc., and personal fees from Spine Biopharma, LLC Vertical Spine, 4WEB Medical/4WEB, Inc., Orthofix Medical Inc. (formerly Spinal Kinetics, Inc.), Woven Orthopedic Technologies, Orthobond Corporation, Healthpoint Capital Partners, LP Bonovo Orthopedics, Inc., Viscogliosi Brothers, LLC, Medical Device Partners II, LLC, RTI Surgical, Inc., Tissue Differentiation Intelligence, LLC, and NuVasive, Inc., outside the submitted work. Andrew A. Sama, MD, reports royalties from Ortho Development Corp., stock ownership in Paradigm Spine LLC, Vestia Ventures MiRus Investment LLC, and Integrity Implants, stock ownership and institutional research support from Spinal Kinetics Inc., advisory board membership and consulting fees from Clariance Inc., Kuros Biosciences AG, and DePuy Spine Products & Medical Device Business Services, consulting fees from 4WEB Inc., and institutional research support from MiMedx Group Inc., outside the submitted work. Alexander P. Hughes, MD, reports grants from Nuvasive, Inc., and institutional research support from Pfizer, Inc., 4WEB Medical, and Kuros Biosciences, outside the submitted work. Federico P. Girardi, MD, reports grants and personal fees from Nuvasive, Inc., and personal fees from Depuy Synthes Spine, EIT Emerging Implant Technologies, Spineart USA, Inc., Ethicon, Inc., Bonovo Orthopedics, Inc., Liventa Bioscience, Paradigm Spine, LLC, Healthpoint Capital Partners, LP, Alphatec Holdings, LLC, LANX, Inc., Centinel Spine, Inc., Tissue Differentiation Intelligence, Spinal Kinetics, Inc., Ortho Development Corp., and Zimmer Biomet Holdings, Inc., outside the submitted work.
Human/Animal Rights
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2013.
Informed Consent
Informed consent was obtained from all patients included in this study.
Required Author Forms
Disclosure forms provided by the authors are available with the online version of this article.
Footnotes
Level of Evidence: Level 2: prognostic study
References
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