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Domagoj Coric, Jack Zigler, Peter Derman, Ernest Braxton, Aaron Situ, and Leena Patel

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.

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Andrew K. Chan, Praveen V. Mummaneni, John F. Burke, Rory R. Mayer, Erica F. Bisson, Joshua Rivera, Brenton Pennicooke, Kai-Ming Fu, Paul Park, Mohamad Bydon, Steven D. Glassman, Kevin T. Foley, Christopher I. Shaffrey, Eric A. Potts, Mark E. Shaffrey, Domagoj Coric, John J. Knightly, Michael Y. Wang, Jonathan R. Slotkin, Anthony L. Asher, Michael S. Virk, Panagiotis Kerezoudis, Mohammed A. Alvi, Jian Guan, Regis W. Haid, and Dean Chou

OBJECTIVE

Reduction of Meyerding grade is often performed during fusion for spondylolisthesis. Although radiographic appearance may improve, correlation with patient-reported outcomes (PROs) is rarely reported. In this study, the authors’ aim was to assess the impact of spondylolisthesis reduction on 24-month PRO measures after decompression and fusion surgery for Meyerding grade I degenerative lumbar spondylolisthesis.

METHODS

The Quality Outcomes Database (QOD) was queried for patients undergoing posterior lumbar fusion for spondylolisthesis with a minimum 24-month follow-up, and quantitative correlation between Meyerding slippage reduction and PROs was performed. Baseline and 24-month PROs, including the Oswestry Disability Index (ODI), EQ-5D, Numeric Rating Scale (NRS)–back pain (NRS-BP), NRS-leg pain (NRS-LP), and satisfaction (North American Spine Society patient satisfaction questionnaire) scores were noted. Multivariable regression models were fitted for 24-month PROs and complications after adjusting for an array of preoperative and surgical variables. Data were analyzed for magnitude of slippage reduction and correlated with PROs. Patients were divided into two groups: < 3 mm reduction and ≥ 3 mm reduction.

RESULTS

Of 608 patients from 12 participating sites, 206 patients with complete data were identified in the QOD and included in this study. Baseline patient demographics, comorbidities, and clinical characteristics were similarly distributed between the cohorts except for depression, listhesis magnitude, and the proportion with dynamic listhesis (which were accounted for in the multivariable analysis). One hundred four (50.5%) patients underwent lumbar decompression and fusion with slippage reduction ≥ 3 mm (mean 5.19, range 3 to 11), and 102 (49.5%) patients underwent lumbar decompression and fusion with slippage reduction < 3 mm (mean 0.41, range 2 to −2). Patients in both groups (slippage reduction ≥ 3 mm, and slippage reduction < 3 mm) reported significant improvement in all primary patient reported outcomes (all p < 0.001). There was no significant difference with regard to the PROs between patients with or without intraoperative reduction of listhesis on univariate and multivariable analyses (ODI, EQ-5D, NRS-BP, NRS-LP, or satisfaction). There was no significant difference in complications between cohorts.

CONCLUSIONS

Significant improvement was found in terms of all PROs in patients undergoing decompression and fusion for lumbar spondylolisthesis. There was no correlation with clinical outcomes and magnitude of Meyerding slippage reduction.

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Marios C. Papadopoulos and Samira Saadoun

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Erica F Bisson, Jian Guan, Mohamad Bydon, Mohammed A Alvi, Anshit Goyal, Steven D Glassman, Kevin T Foley, Eric A Potts, Christopher I Shaffrey, Mark E Shaffrey, Domagoj Coric, John J Knightly, Paul Park, Michael Y Wang, Kai-Ming Fu, Jonathan R Slotkin, Anthony L Asher, Michael S Virk, Andrew Y Yew, Regis W Haid, Andrew K Chan, and Praveen V Mummaneni

OBJECTIVE

The ideal surgical management of grade I lumbar spondylolisthesis has not been determined despite extensive prior investigations. In this cohort study, the authors used data from the large, multicenter, prospectively collected Quality Outcomes Database to bridge the gap between the findings in previous randomized trials and those in a more heterogeneous population treated in a typical practice. The objective was to assess the difference in patient-reported outcomes among patients undergoing decompression alone or decompression plus fusion.

METHODS

The primary outcome measure was change in 24-month Oswestry Disability Index (ODI) scores. The minimal clinically important difference (MCID) in ODI score change and 30% change in ODI score at 24 months were also evaluated. After adjusting for patient-specific and clinical factors, multivariable linear and logistic regressions were employed to evaluate the impact of fusion on outcomes. To account for differences in age, sex, body mass index, and baseline listhesis, a sensitivity analysis was performed using propensity score analysis to match patients undergoing decompression only with those undergoing decompression and fusion.

RESULTS

In total, 608 patients who had grade I lumbar spondylolisthesis were identified (85.5% with at least 24 months of follow-up); 140 (23.0%) underwent decompression alone and 468 (77.0%) underwent decompression and fusion. The 24-month change in ODI score was significantly greater in the fusion plus decompression group than in the decompression-only group (−25.8 ± 20.0 vs −15.2 ± 19.8, p < 0.001). Fusion remained independently associated with 24-month ODI score change (B = −7.05, 95% CI −10.70 to −3.39, p ≤ 0.001) in multivariable regression analysis, as well as with achieving the MCID for the ODI score (OR 1.767, 95% CI 1.058–2.944, p = 0.029) and 30% change in ODI score (OR 2.371, 95% CI 1.286–4.371, p = 0.005). Propensity score analysis resulted in 94 patients in the decompression-only group matched 1 to 1 with 94 patients in the fusion group. The addition of fusion to decompression remained a significant predictor of 24-month change in the ODI score (B = 2.796, 95% CI 2.228–13.275, p = 0.006) and of achieving the 24-month MCID ODI score (OR 2.898, 95% CI 1.214–6.914, p = 0.016) and 24-month 30% change in ODI score (OR 2.300, 95% CI 1.014–5.216, p = 0.046).

CONCLUSIONS

These results suggest that decompression plus fusion in patients with grade I lumbar spondylolisthesis may be associated with superior outcomes at 24 months compared with decompression alone, both in reduction of disability and in achieving clinically meaningful improvement. Longer-term follow-up is warranted to assess whether this effect is sustained.

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Meng Huang, Avery Buchholz, Anshit Goyal, Erica Bisson, Zoher Ghogawala, Eric Potts, John Knightly, Domagoj Coric, Anthony Asher, Kevin Foley, Praveen V. Mummaneni, Paul Park, Mark Shaffrey, Kai-Ming Fu, Jonathan Slotkin, Steven Glassman, Mohamad Bydon, and Michael Wang

OBJECTIVE

Surgical treatment for degenerative spondylolisthesis has been proven to be clinically challenging and cost-effective. However, there is a range of thresholds that surgeons utilize for incorporating fusion in addition to decompressive laminectomy in these cases. This study investigates these surgeon- and site-specific factors by using the Quality Outcomes Database (QOD).

METHODS

The QOD was queried for all cases that had undergone surgery for grade 1 spondylolisthesis from database inception to February 2019. In addition to patient-specific covariates, surgeon-specific covariates included age, sex, race, years in practice (0–10, 11–20, 21–30, > 30 years), and fellowship training. Site-specific variables included hospital location (rural, suburban, urban), teaching versus nonteaching status, and hospital type (government, nonfederal; private, nonprofit; private, investor owned). Multivariable regression and predictor importance analyses were performed to identify predictors of the treatment performed (decompression alone vs decompression and fusion). The model was clustered by site to account for site-specific heterogeneity in treatment selection.

RESULTS

A total of 12,322 cases were included with 1988 (16.1%) that had undergone decompression alone. On multivariable regression analysis clustered by site, adjusting for patient-level clinical covariates, no surgeon-specific factors were found to be significantly associated with the odds of selecting decompression alone as the surgery performed. However, sites located in suburban areas (OR 2.32, 95% CI 1.09–4.84, p = 0.03) were more likely to perform decompression alone (reference = urban). Sites located in rural areas had higher odds of performing decompression alone than hospitals located in urban areas, although the results were not statistically significant (OR 1.33, 95% CI 0.59–2.61, p = 0.49). Nonteaching status was independently associated with lower odds of performing decompression alone (OR 0.40, 95% CI 0.19–0.97, p = 0.04). Predictor importance analysis revealed that the most important determinants of treatment selection were dominant symptom (Wald χ2 = 34.7, accounting for 13.6% of total χ2) and concurrent diagnosis of disc herniation (Wald χ2 = 31.7, accounting for 12.4% of total χ2). Hospital teaching status was also found to be relatively important (Wald χ2 = 4.2, accounting for 1.6% of total χ2) but less important than other patient-level predictors.

CONCLUSIONS

Nonteaching centers were more likely to perform decompressive laminectomy with supplemental fusion for spondylolisthesis. Suburban hospitals were more likely to perform decompression only. Surgeon characteristics were not found to influence treatment selection after adjustment for clinical covariates. Further large database registry experience from surgeons at high-volume academic centers at which surgically and medically complex patients are treated may provide additional insight into factors associated with treatment preference for degenerative spondylolisthesis.

Open access

Kee D. Kim, K. Stuart Lee, Domagoj Coric, Jason J. Chang, James S. Harrop, Nicholas Theodore, and Richard M. Toselli

OBJECTIVE

The aim of this study was to evaluate whether the investigational Neuro-Spinal Scaffold (NSS), a highly porous bioresorbable polymer device, demonstrates probable benefit for safety and neurological recovery in patients with complete (AIS grade A) T2–12 spinal cord injury (SCI) when implanted ≤ 96 hours postinjury.

METHODS

This was a prospective, open-label, multicenter, single-arm study in patients with a visible contusion on MRI. The NSS was implanted into the epicenter of the postirrigation intramedullary spinal cord contusion cavity with the intention of providing structural support to the injured spinal cord parenchyma. The primary efficacy endpoint was the proportion of patients who had an improvement of ≥ 1 AIS grade (i.e., conversion from complete paraplegia to incomplete paraplegia) at the 6-month follow-up visit. A preset objective performance criterion established for the study was defined as an AIS grade conversion rate of ≥ 25%. Secondary endpoints included change in neurological level of injury (NLI). This analysis reports on data through 6-month follow-up assessments.

RESULTS

Nineteen patients underwent NSS implantation. There were 3 early withdrawals due to death, which were all determined by investigators to be unrelated to the NSS or the implantation procedure. Seven of 16 patients (43.8%) who completed the 6-month follow-up visit had conversion of neurological status (AIS grade A to grade B [n = 5] or C [n = 2]). Five patients showed improvement in NLI of 1 to 2 levels compared with preimplantation assessment, 3 patients showed no change, and 8 patients showed deterioration of 1 to 4 levels. There were no unanticipated or serious adverse device effects or serious adverse events related to the NSS or the implantation procedure as determined by investigators.

CONCLUSIONS

In this first-in-human study, implantation of the NSS within the spinal cord appeared to be safe in the setting of surgical decompression and stabilization for complete (AIS grade A) thoracic SCI. It was associated with a 6-month AIS grade conversion rate that exceeded historical controls. The INSPIRE study data demonstrate that the potential benefits of the NSS outweigh the risks in this patient population and support further clinical investigation in a randomized controlled trial.

Clinical trial registration no.: NCT02138110 (clinicaltrials.gov)

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Suyash Singh, Jayesh Sardhara, Anant Mehrotra, and Sanjay Behari

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Anthony M. DiGiorgio, Praveen V. Mummaneni, Paul Park, Andrew K. Chan, Erica F. Bisson, Mohamad Bydon, Kevin T. Foley, Steven D. Glassman, Christopher I. Shaffrey, Eric A. Potts, Mark E. Shaffrey, Domagoj Coric, John J. Knightly, Michael Y. Wang, Kai-Ming Fu, Anthony L. Asher, Michael S. Virk, Panagiotis Kerezoudis, Mohammed Ali Alvi, Jian Guan, Regis W. Haid Jr., and Jonathan R. Slotkin

OBJECTIVE

Return to work (RTW) and satisfaction are important outcome measures after surgery for degenerative spine disease. The authors queried the prospective Quality Outcomes Database (QOD) to determine if RTW correlated with patient satisfaction.

METHODS

The QOD was queried for patients undergoing surgery for degenerative lumbar spondylolisthesis. The primary outcome of interest was correlation between RTW and patient satisfaction, as measured by the North American Spine Society patient satisfaction index (NASS). Secondarily, data on satisfied patients were analyzed to see what patient factors correlated with RTW.

RESULTS

Of 608 total patients in the QOD spondylolisthesis data set, there were 292 patients for whom data were available on both satisfaction and RTW status. Of these, 249 (85.3%) were satisfied with surgery (NASS score 1–2), and 224 (76.7%) did RTW after surgery. Of the 68 patients who did not RTW after surgery, 49 (72.1%) were still satisfied with surgery. Of the 224 patients who did RTW, 24 (10.7%) were unsatisfied with surgery (NASS score 3–4). There were significantly more people who had an NASS score of 1 in the RTW group than in the non-RTW group (71.4% vs 42.6%, p < 0.05). Failure to RTW was associated with lower level of education, worse baseline back pain (measured with a numeric rating scale), and worse baseline disability (measured with the Oswestry Disability Index [ODI]).

CONCLUSIONS

There are a substantial number of patients who are satisfied with surgery even though they did not RTW. Patients who were satisfied with surgery and did not RTW typically had worse preoperative back pain and ODI and typically did not have a college education. While RTW remains an important measure after surgery, physicians should be mindful that patients who do not RTW may still be satisfied with their outcome.

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Vincent Rossi, Anthony Asher, David Peters, Scott L. Zuckerman, Mark Smith, Martin Henegar, Hunter Dyer, Domagoj Coric, Deborah Pfortmiller, Tim Adamson, and Matthew McGirt

OBJECTIVE

Several studies have demonstrated that anterior cervical discectomy and fusion (ACDF) surgery in the outpatient versus hospital setting provides improved efficiency, cost-effectiveness, and patient satisfaction without a compromise in safety or outcome. Recent anecdotal reports, however, have questioned whether outpatient ACDF surgery is safe in the > 65-year-old Medicare population. To date, no clinical study has assessed the safety of outpatient ACDF in an ambulatory surgery center (ASC), specifically in a Medicare population. The authors set out to analyze their 3-year experience with Medicare-enrolled patients undergoing ACDF surgery at a single ASC to determine its safety profile, perioperative care protocol, and associated outcomes.

METHODS

A retrospective analysis of 119 consecutive patients > 65 years (Medicare-eligible) who underwent 1-, 2-, or 3-level ACDF at a single ASC from 2015 to 2018 (since Medicare payment approval) was conducted. All patients were in American Society of Anesthesiologists classes I–III. Postoperatively, patients were observed for a minimum of 4 hours in a recovery setting for the following factors: neck swelling, neurological status, ability to swallow solid food, and urination capacity. All patients received a multimodal pain management regimen prior to discharge home. Data were collected on patient demographics, comorbidities, operative details, and all perioperative and 90-day morbidity.

RESULTS

Complete data were available for all 119 consecutive Medicare-eligible patients, 97 (81.5%) of whom were actively enrolled in Medicare. One-, 2-, and 3-level ACDFs were performed in 103 (86.6%), 15 (12.6%), and 1 (0.8%) patients, respectively. No patients required return to the operating room for intervention within the 4-hour postanesthesia care unit observation window. No patients required transfer from the ASC to the hospital setting for further observation or intervention. Thirty-day adverse events were reported in 2.4% of cases, all of which resolved by 90 days after surgery. The incidence of 90-day hospital readmission was 1.7% (n = 2), with 1 patient (0.8%) requiring reoperation at the index level for deep infection. All-cause 90-day mortality was 0%.

CONCLUSIONS

An analysis of consecutive Medicare patients (American Society of Anesthesiologists classes I–III) who underwent mostly 1-level and some 2-level ACDFs in an ASC setting demonstrates that surgical complications occur at a low rate with a safety profile similar to that reported for both inpatient ACDF and patients younger than 65 years. In an effort to reduce cost and improve efficiency of care, surgeons can safely perform ACDF in the Medicare population in an ASC environment utilizing patient selection criteria and perioperative management similar to those reported here.

Free access

Andrew K. Chan, Erica F. Bisson, Mohamad Bydon, Steven D. Glassman, Kevin T. Foley, Eric A. Potts, Christopher I. Shaffrey, Mark E. Shaffrey, Domagoj Coric, John J. Knightly, Paul Park, Michael Y. Wang, Kai-Ming Fu, Jonathan R. Slotkin, Anthony L. Asher, Michael S. Virk, Panagiotis Kerezoudis, Mohammed Ali Alvi, Jian Guan, Regis W. Haid, and Praveen V. Mummaneni

OBJECTIVE

The optimal minimally invasive surgery (MIS) approach for grade 1 lumbar spondylolisthesis is not clearly elucidated. In this study, the authors compared the 24-month patient-reported outcomes (PROs) after MIS transforaminal lumbar interbody fusion (TLIF) and MIS decompression for degenerative lumbar spondylolisthesis.

METHODS

A total of 608 patients from 12 high-enrolling sites participating in the Quality Outcomes Database (QOD) lumbar spondylolisthesis module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis, of whom 143 underwent MIS (72 MIS TLIF [50.3%] and 71 MIS decompression [49.7%]). Surgeries were classified as MIS if there was utilization of percutaneous screw fixation and placement of a Wiltse plane MIS intervertebral body graft (MIS TLIF) or if there was a tubular decompression (MIS decompression). Parameters obtained at baseline through at least 24 months of follow-up were collected. PROs included the Oswestry Disability Index (ODI), numeric rating scale (NRS) for back pain, NRS for leg pain, EuroQol-5D (EQ-5D) questionnaire, and North American Spine Society (NASS) satisfaction questionnaire. Multivariate models were constructed to adjust for patient characteristics, surgical variables, and baseline PRO values.

RESULTS

The mean age of the MIS cohort was 67.1 ± 11.3 years (MIS TLIF 62.1 years vs MIS decompression 72.3 years) and consisted of 79 (55.2%) women (MIS TLIF 55.6% vs MIS decompression 54.9%). The proportion in each cohort reaching the 24-month follow-up did not differ significantly between the cohorts (MIS TLIF 83.3% and MIS decompression 84.5%, p = 0.85). MIS TLIF was associated with greater blood loss (mean 108.8 vs 33.0 ml, p < 0.001), longer operative time (mean 228.2 vs 101.8 minutes, p < 0.001), and longer length of hospitalization (mean 2.9 vs 0.7 days, p < 0.001). MIS TLIF was associated with a significantly lower reoperation rate (14.1% vs 1.4%, p = 0.004). Both cohorts demonstrated significant improvements in ODI, NRS back pain, NRS leg pain, and EQ-5D at 24 months (p < 0.001, all comparisons relative to baseline). In multivariate analyses, MIS TLIF—as opposed to MIS decompression alone—was associated with superior ODI change (β = −7.59, 95% CI −14.96 to −0.23; p = 0.04), NRS back pain change (β = −1.54, 95% CI −2.78 to −0.30; p = 0.02), and NASS satisfaction (OR 0.32, 95% CI 0.12–0.82; p = 0.02).

CONCLUSIONS

For symptomatic, single-level degenerative spondylolisthesis, MIS TLIF was associated with a lower reoperation rate and superior outcomes for disability, back pain, and patient satisfaction compared with posterior MIS decompression alone. This finding may aid surgical decision-making when considering MIS for degenerative lumbar spondylolisthesis.