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Dosing Strategy for Osteobiologics Used in ACDF Surgery: Influence on Fusion Rates and Associated Complications. A Systematic Literature Review
Hamouda, Waeel O; Veranis, Sotiris; Krol, Oscar; Sagoo, Navraj S; Passias, Peter G; Buser, Zorica; Meisel, Hans Jörg; Yoon, Tim; ,
STUDY DESIGN/METHODS:Systematic review. OBJECTIVE:To assess the available evidence related to dose-dependent effectiveness (i.e., bone fusion) and morbidity of osteobiologics used in anterior cervical discectomy and fusion (ACDF). METHODS:Studies with more than 9 adult patients with degenerated/herniated cervical discs operated for one-to four-levels ACDF reporting used osteobiologics doses, fusion rates at six months or later, and related comorbidities were included. PubMed, EMBASE, ClinicalTrials, and Cochrane were searched through September 2021. Data extracted in spread sheet and risk of bias assessed using MINORS and Rob-2. RESULTS:Sixteen studies were selected and sub-grouped into BMP and non-BMP osteobiologics. For the 10 BMP studies, doses varied from 0.26 to 2.1 mg in 649 patients with fusion rates of 95.3 to 100% at 12 months. For other osteobiologics, each of six studies reported one type of osteobiologic in certain dose/concentration/volume in a total of 580 patients with fusion rates of 6.8 to 96.9% at 12 months. Risk of bias was low in three of the 13 non-randomized (18.75%) and in all the three randomized studies (100%). CONCLUSIONS:Taking into account the inconsistent reporting within available literature, for BMP usage in ACDF, doses lower than 0.7 mg per level can achieve equal successful fusion rates as higher doses, and there is no complication-free dose proved yet. It seems that the lower the dose the lower the incidence of serious complications. As for non-BMP osteobiologics the studies are very limited for each osteobiologic and thus conclusions must be drawn individually and with caution.
PMCID:10913908
PMID: 38421331
ISSN: 2192-5682
CID: 5722762
Highest Achievable Outcomes for Adult Spinal Deformity Corrective Surgery: Does Frailty Severity Exert a Ceiling Effect?
Passias, Peter G; Onafowokan, Oluwatobi O; Tretiakov, Peter; Williamson, Tyler; Kummer, Nicholas; Mir, Jamshaid; Das, Ankita; Krol, Oscar; Passfall, Lara; Joujon-Roche, Rachel; Imbo, Bailey; Yee, Timothy; Sciubba, Daniel; Paulino, Carl B; Schoenfeld, Andrew J; Smith, Justin S; Lafage, Renaud; Lafage, Virginie
STUDY DESIGN/METHODS:Retrospective single-center study. OBJECTIVE:To assess the influence of frailty on optimal outcome following ASD corrective surgery. SUMMARY OF BACKGROUND DATA/BACKGROUND:Frailty is a determining factor in outcomes after ASD surgery and may exert a ceiling effect on the best possible outcome. METHODS:ASD patients with frailty measures, baseline, and 2-year ODI included. Frailty was classified as Not Frail (NF), Frail (F) and Severely Frail (SF) based on the modified Frailty Index, then stratified into quartiles based on two-year ODI improvement (most improved designated "Highest"). Logistic regression analyzed relationships between frailty and ODI score and improvement, maintenance, or deterioration. A Kaplan-Meier survival curve was used to analyze differences in time to complication or reoperation. RESULTS:A total of 393 ASD patients were isolated (55.2% NF, 31.0% F, and 13.7% SF), then classified as 12.5% NF-Highest, 17.8% F-Highest, and 3.1% SF-Highest. The SF group had the highest rate of deterioration (16.7%, P =0.025) in the second postoperative year, but the groups were similar in improvement (NF: 10.1%, F: 11.5%, SF: 9.3%, P =0.886). Improvement of SF patients was greatest at six months (ΔODI of -22.6±18.0, P <0.001), but NF and F patients reached maximal ODI at 2 years (ΔODI of -15.7±17.9 and -20.5±18.4, respectively). SF patients initially showed the greatest improvement in ODI (NF: -4.8±19.0, F: -12.4±19.3, SF: -22.6±18.0 at six months, P <0.001). A Kaplan-Meier survival curve showed a trend of less time to major complication or reoperation by 2 years with increasing frailty (NF: 7.5±0.381 yr, F: 6.7±0.511 yr, SF: 5.8±0.757 yr; P =0.113). CONCLUSIONS:Increasing frailty had a negative effect on maximal improvement, where severely frail patients exhibited a parabolic effect with greater initial improvement due to higher baseline disability, but reached a ceiling effect with less overall maximal improvement. Severe frailty may exert a ceiling effect on improvement and impair maintenance of improvement following surgery. LEVEL OF EVIDENCE/METHODS:Level III.
PMID: 38595092
ISSN: 1528-1159
CID: 5725772
Mechanisms of lumbar spine "flattening" in adult spinal deformity: defining changes in shape that occur relative to a normative population
Lafage, Renaud; Mota, Frank; Khalifé, Marc; Protopsaltis, Themistocles; Passias, Peter G; Kim, Han-Jo; Line, Breton; Elysée, Jonathan; Mundis, Gregory; Shaffrey, Christopher I; Ames, Christopher P; Klineberg, Eric O; Gupta, Munish C; Burton, Douglas C; Lenke, Lawrence G; Bess, Shay; Smith, Justin S; Schwab, Frank J; Lafage, Virginie; ,
PURPOSE/OBJECTIVE:Previous work comparing ASD to a normative population demonstrated that a large proportion of lumbar lordosis is lost proximally (L1-L4). The current study expands on these findings by collectively investigating regional angles and spinal contours. METHODS:119 asymptomatic volunteers with full-body free-standing radiographs were used to identify age-and-PI models of each Vertebra Pelvic Angle (VPA) from L5 to T10. These formulas were then applied to a cohort of primary surgical ASD patients without coronal malalignment. Loss of lumbar lordosis (LL) was defined as the offset between age-and-PI normative value and pre-operative alignment. Spine shapes defined by VPAs were compared and analyzed using paired t-tests. RESULTS:362 ASD patients were identified (age = 64.4 ± 13, 57.1% females). Compared to their age-and-PI normative values, patients demonstrated a significant loss in LL of 17 ± 19° in the following distribution: 14.1% had "No loss" (mean = 0.1 ± 2.3), 22.9% with 10°-loss (mean = 9.9 ± 2.9), 22.1% with 20°-loss (mean = 20.0 ± 2.8), and 29.3% with 30°-loss (mean = 33.8 ± 6.0). "No loss" patients' spine was slightly posterior to the normative shape from L4 to T10 (VPA difference of 2°), while superimposed on the normative one from S1 to L2 and became anterior at L1 in the "10°-loss" group. As LL loss increased, ASD and normative shapes offset extended caudally to L3 for the "20°-loss" group and L4 for the "30°-loss" group. CONCLUSION/CONCLUSIONS:As LL loss increases, the difference between ASD and normative shapes first occurs proximally and then progresses incrementally caudally. Understanding spinal contour and LL loss location may be key to achieving sustainable correction by identifying optimal and personalized postoperative shapes.
PMID: 39068280
ISSN: 1432-0932
CID: 5711382
Can Baseline Disability Predict Outcomes in Adult Spinal Deformity Surgery?
Passias, Peter G; Joujon-Roche, Rachel; Mir, Jamshaid M; Tretiakov, Peter; Dave, Pooja; Williamson, Tyler K; Imbo, Bailey; Krol, Oscar; Schoenfeld, Andrew J
STUDY DESIGN/METHODS:Retrospective Cohort Study. OBJECTIVE:To assess if there is a threshold of baseline disability beyond which the patient-reported outcomes after surgical correction of adult spinal deformity (ASD) are adversely impacted. BACKGROUND:Patient-reported outcomes vary after correction of adult spinal deformity, even when patients are optimally realigned. There is a paucity of literature examining the impact of baseline disability on patient-reported outcomes in ASD. METHODS:Patients with baseline (BL) and two-year data were included. Disability was ranked according to BL Oswestry Disability Index (ODI) into quintiles: Q1 (lowest ODI score) to Q5 (highest ODI score). Adjusted logistic regression analyses evaluated the likelihood of reaching ≥1 MCID in Scoliosis Research Society Outcomes Questionnaire (SRS-22) Pain, SRS-22 Activity, and Short Form-36 physical component summary at two years across disability groups Q1-Q4 with respect to Q5. Sensitivity tests were performed, excluding patients with any "0" Schwab modifiers at BL. RESULTS:Compared with patients in Q5, the odds of reaching MCID in SRS-22 Pain at 2Y were significantly higher for those in Q1 (OR: 3.771), Q2 (OR: 3.006), and Q3 (OR: 2.897), all P <0.021. Similarly, compared with patients in Q5, the odds of reaching MCID in SRS-22 Activity at two years were significantly higher for those in Q2 (OR: 3.454) and Q3 (OR: 2.801), both P <0.02. Lastly, compared with patients in Q5, odds of reaching MCID in Short Form-36 physical component summary at two years were significantly higher for patients in Q1 (OR: 5.350), Q2 (OR: 4.795), and Q3 (OR: 6.229), all P <0.004. CONCLUSIONS:This study found that patients presenting with moderate disability at BL (ODI<40) consistently surpassed health-related quality of life outcomes as compared with those presenting with greater levels of disability. We propose that a baseline ODI of 40 represents a disability threshold within which operative inte rvention maximizes patient-reported outcomes. Furthermore, delaying the intervention until patients progress to severe disability may limit the benefits of surgical correction in ASD patients. LEVEL OF EVIDENCE/METHODS:3.
PMID: 37593949
ISSN: 1528-1159
CID: 5691032
Hip Osteoarthritis in Patients Undergoing Surgery for Severe Adult Spinal Deformity: Prevalence and Impact on Spine Surgery Outcomes
Diebo, Bassel G; Alsoof, Daniel; Balmaceno-Criss, Mariah; Daher, Mohammad; Lafage, Renaud; Passias, Peter G; Ames, Christopher P; Shaffrey, Christopher I; Burton, Douglas C; Deviren, Vedat; Line, Breton G; Soroceanu, Alex; Hamilton, D Kojo; Klineberg, Eric O; Mundis, Gregory M; Kim, Han Jo; Gum, Jeffrey L; Smith, Justin S; Uribe, Juan S; Kebaish, Khaled M; Gupta, Munish C; Nunley, Pierce D; Eastlack, Robert K; Hostin, Richard; Protopsaltis, Themistocles S; Lenke, Lawrence G; Hart, Robert A; Schwab, Frank J; Bess, Shay; Lafage, Virginie; Daniels, Alan H; ,
BACKGROUND:Hip osteoarthritis (OA) is common in patients with adult spinal deformity (ASD). Limited data exist on the prevalence of hip OA in patients with ASD, or on its impact on baseline and postoperative alignment and patient-reported outcome measures (PROMs). Therefore, this paper will assess the prevalence and impact of hip OA on alignment and PROMs. METHODS:Patients with ASD who underwent L1-pelvis or longer fusions were included. Two independent reviewers graded hip OA with the Kellgren-Lawrence (KL) classification and stratified it by severity into non-severe (KL grade 1 or 2) and severe (KL grade 3 or 4). Radiographic parameters and PROMs were compared among 3 patient groups: Hip-Spine (hip KL grade 3 or 4 bilaterally), Unilateral (UL)-Hip (hip KL grade 3 or 4 unilaterally), or Spine (hip KL grade 1 or 2 bilaterally). RESULTS:Of 520 patients with ASD who met inclusion criteria for an OA prevalence analysis, 34% (177 of 520) had severe bilateral hip OA and unilateral or bilateral hip arthroplasty had been performed in 8.7% (45 of 520). A subset of 165 patients had all data components and were examined: 68 Hip-Spine, 32 UL-Hip, and 65 Spine. Hip-Spine patients were older (67.9 ± 9.5 years, versus 59.6 ± 10.1 years for Spine and 65.8 ± 7.5 years for UL-Hip; p < 0.001) and had a higher frailty index (4.3 ± 2.6, versus 2.7 ± 2.0 for UL-Hip and 2.9 ± 2.0 for Spine; p < 0.001). At 1 year, the groups had similar lumbar lordosis, yet the Hip-Spine patients had a worse sagittal vertebral axis (SVA) measurement (45.9 ± 45.5 mm, versus 25.1 ± 37.1 mm for UL-Hip and 19.0 ± 39.3 mm for Spine; p = 0.001). Hip-Spine patients also had worse Veterans RAND-12 Physical Component Summary scores at baseline (25.7 ± 9.3, versus 28.7 ± 9.8 for UL-Hip and 31.3 ± 10.5 for Spine; p = 0.005) and 1 year postoperatively (34.5 ± 11.4, versus 40.3 ± 10.4 for UL-Hip and 40.1 ± 10.9 for Spine; p = 0.006). CONCLUSIONS:This study of operatively treated ASD revealed that 1 in 3 patients had severe hip OA bilaterally. Such patients with severe bilateral hip OA had worse baseline SVA and PROMs that persisted 1 year following ASD surgery, despite correction of lordosis. LEVEL OF EVIDENCE/METHODS:Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
PMID: 38958659
ISSN: 1535-1386
CID: 5698302
Should pelvic incidence influence realignment strategy? A detailed analysis in adult spinal deformity
Williamson, Tyler K; Onafowokan, Oluwatobi O; Schoenfeld, Andrew J; Owusu-Sarpong, Stephane; Lebovic, Jordan; Mir, Jamshaid; Das, Ankita; Lorentz, Nathan; Galetta, Matthew; Jankowski, Pawel P; Lafage, Renaud; Lafage, Virginie; Passias, Peter G
OBJECTIVE:The purpose of this study was to assess how various realignment strategies affect mechanical failure and clinical outcomes in pelvic incidence (PI)-stratified cohorts following adult spinal deformity (ASD) surgery. METHODS:Median and interquartile range statistics were calculated for demographics and surgical details. Further statistical analysis was used to define subsets within PI generating significantly different rates of mechanical failure. These subsets of PI were further analyzed as subcohorts for the outcomes and effects of realignment within each subcohort. Multivariate logistic regression analysis controlling for baseline frailty and lumbar lordosis (LL; L1-S1) analyzed the association of age-adjusted realignment and Global Alignment and Proportion (GAP) strategies with the incidence of mechanical failure and clinical improvement within PI-stratified groups. RESULTS:A parabolic relationship between PI and mechanical failure was noted, whereas patients with either < 51° (n = 174, 39.1% of cohort) or > 63° (n = 114, 25.6% of cohort) of PI generated higher rates of mechanical failure (18.0% and 20.0%, respectively) and lower rates of good outcome (80.3% and 77.6%, respectively) than those with moderate PI (51°-63°). Patients with lower PI more often met good outcome criteria when undercorrected in age-adjusted PI-LL mismatch and sagittal age-adjusted score, and those not meeting good outcome criteria were more likely to deteriorate in GAP relative LL from first to final follow-up (OR 13.4, 95% CI 1.3-139.2). In those with moderate PI, patients were more likely to meet good outcome when aligned on the GAP lordosis distribution index (LDI; OR 1.7, 95% CI 0.9-3.3). Patients with higher PI meeting good outcome were more likely to be overcorrected in sagittal vertical axis (OR 2.4, 95% CI 1.1-5.2) at first follow-up and less likely to be undercorrected in T1 pelvic angle (OR 0.4, 95% CI 0.2-0.9) by final follow-up. When assessing GAP alignment, patients were more likely to meet good outcome when aligned on GAP LDI (OR 3.5, 95% CI 1.4-8.9). CONCLUSIONS:There was a parabolic relationship between PI and both mechanical failure and clinical improvement following deformity correction in this study. Understanding the associations between this fixed parameter and poor outcomes can aid the surgeon in strategical planning when seeking to realign ASD.
PMID: 39241258
ISSN: 1547-5646
CID: 5688352
Expectations of clinical improvement following corrective surgery for adult cervical deformity based on functional disability at presentation
Passias, Peter G; Onafowokan, Oluwatobi O; Joujon-Roche, Rachel; Smith, Justin; Tretiakov, Peter; Buell, Thomas; Diebo, Bassel G; Daniels, Alan H; Gum, Jeffrey L; Hamiltion, D Kojo; Soroceanu, Alex; Scheer, Justin; Eastlack, Robert K; Fessler, Richard G; Klineberg, Eric O; Kim, Han Jo; Burton, Douglas C; Schwab, Frank J; Bess, Shay; Lafage, Virginie; Shaffrey, Christopher I; Ames, Christopher; ,
PURPOSE/OBJECTIVE:To assess impact of baseline disability on HRQL outcomes. METHODS:CD patients with baseline (BL) and 2 year (2Y) data included, and ranked into quartiles by baseline NDI, from lowest/best score (Q1) to highest/worst score (Q4). Means comparison tests analyzed differences between quartiles. ANCOVA and logistic regressions assessed differences in outcomes while accounting for covariates (BL deformity, comorbidities, HRQLs, surgical details and complications). RESULTS:, CCI: 0.94 ± 1.31). The cohort mean cSVA was 38.54 ± 19.43 mm and TS-CL: 37.34 ± 19.73. Mean BL NDI by quartile was: Q1: 25.04 ± 8.19, Q2: 41.61 ± 2.77, Q3: 53.31 ± 4.32, and Q4: 69.52 ± 8.35. Q2 demonstrated greatest improvement in NRS Neck at 2Y (-3.93), compared to Q3 (-1.61, p = .032) and Q4 (-1.41, p = .015). Q2 demonstrated greater improvement in NRS Back (-1.71), compared to Q4 (+ 0.84, p = .010). Q2 met MCID in NRS Neck at the highest rates (69.9%), especially compared to Q4 (30.3%), p = .039. Q2 had the greatest improvement in EQ-5D (+ 0.082), compared to Q1 (+ 0.073), Q3 (+ 0.022), and Q4 (+ 0.014), p = .034. Q2 also had the greatest mJOA improvement (+ 1.517), p = .042. CONCLUSIONS:Patients in Q2, with mean BL NDI of 42, consistently demonstrated the greatest improvement in HRQLs whereas those in Q4, (NDI 70), saw the least. BL NDI between 39 and 44 may represent a disability "Sweet Spot," within which operative intervention maximizes patient-reported outcomes. Furthermore, delaying intervention until patients are severely disabled, beyond an NDI of 61, may limit the benefits of surgery.
PMID: 39083198
ISSN: 2212-1358
CID: 5680262
Closing the Gap: The Incidence of Complications in Minimally Invasive Tubular, Endoscopic, and Robotic-Assisted Transforaminal Lumbar Interbody Fusion Procedures
Gerling, Michael; Baker, Melissa; Stanton, Eloise; Pyun, Joseph; Chaladoff, Evan; Passias, Peter; Buser, Zorica
BACKGROUND:The aim of the current study was to compare the incidence of postoperative complications among minimally invasive surgery (MIS) tubular, endoscopic, and robot-assisted transforaminal lumbar interbody fusion (TLIF) techniques. METHODS:We studied consecutive patients who underwent single-level or multilevel TLIF between 2020 and 2022. Preoperative and postoperative patient-reported outcomes (Visual Analog Scale leg score and Oswestry Disability Index), demographic, and intraoperative variables were recorded. One-way analysis of variance with Bartlett's equal-variance and Pearson chi-squared tests were used. RESULTS:The study included 170 TLIF patients: 107 (63%) tubular, 42 (25%) endoscopic, and 21 (12%) robot assisted. All 3 TLIF techniques had similar complication rates: tubular 6 (5.6%), endoscopic 2 (4.8%), and robot assisted 1 (4.8%) all occurring within the first 2 weeks. Tubular TLIF reported the lowest incidence of new-onset neurologic symptoms, primarily radiculitis or numbness/tingling, at 2 weeks postoperatively (P < 0.05) with 21 (20%) tubular, 17 (41%) endoscopic, and 9 (43%) robot-assisted patients. There were 2 revisions in the robot-assisted group, while tubular and endoscopic each had one within 1 year. There was no statistical difference in preoperative or postoperative patient-reported outcomes between the TLIF groups. CONCLUSIONS:The current study demonstrated that tubular, endoscopic, and robot-assisted TLIF procedures had similar complication rates. The tubular MIS TLIF reported fewer new neurologic symptoms compared with endoscopic and robot-assisted TLIF procedures at 2 weeks postoperative, with all groups declining in symptom persistency at later time intervals. Average Visual Analog Scale scores continuously improved up to 1 year postoperatively among all groups.
PMID: 38914133
ISSN: 1878-8769
CID: 5678322
Is It Possible for Patients with Early Distal Junctional Kyphosis following Adult Cervical Deformity Corrective Surgery to Achieve Similar Outcomes to Their Unaffected Counterparts? An Analysis of Recovery Kinetics
Onafowokan, Oluwatobi O; Imbo, Bailey; Williamson, Tyler; Das, Ankita; Mir, Jamshaid M; Galetta, Matthew; Lorentz, Nathan; Passias, Peter G
PMCID:11172948
PMID: 38892957
ISSN: 2077-0383
CID: 5672062
Restoring L4-S1 Lordosis Shape in Severe Sagittal Deformity: Impact of Correction Techniques on Alignment and Complication Profile
Singh, Manjot; Balmaceno-Criss, Mariah; Daher, Mohammad; Lafage, Renaud; Hamilton, D Kojo; Smith, Justin S; Eastlack, Robert K; Fessler, Richard G; Gum, Jeffrey L; Gupta, Munish C; Hostin, Richard; Kebaish, Khaled M; Klineberg, Eric O; Lewis, Stephen J; Line, Breton G; Nunley, Pierce D; Mundis, Gregory M; Passias, Peter G; Protopsaltis, Themistocles S; Buell, Thomas; Ames, Christopher P; Mullin, Jeffrey P; Soroceanu, Alex; Scheer, Justin K; Lenke, Lawrence G; Bess, Shay; Shaffrey, Christopher I; Schwab, Frank J; Lafage, Virginie; Burton, Douglas C; Diebo, Bassel G; Daniels, Alan H; ,
BACKGROUND CONTEXT/BACKGROUND:Severe sagittal plane deformity with loss of L4-S1 lordosis is disabling and can be improved through various surgical techniques. However, data is limited on the differing ability of anterior lumbar interbody fusion (ALIF), pedicle subtraction osteotomy (PSO), and transforaminal lumbar interbody fusion (TLIF) to achieve alignment goals in severely malaligned patients. PURPOSE/OBJECTIVE:To examine surgical techniques aimed at restoring L4-S1 lordosis in severe adult spinal deformity (ASD). DESIGN/METHODS:Retrospective review of prospectively collected data. PATIENT SAMPLE/METHODS:A total of 96 patients who underwent ALIF, PSO, and TLIF were included in this study. OUTCOME MEASURES/METHODS:The following data were observed for all cases: patient demographics, spinopelvic parameters, complications, and PROMs. METHODS:Severe ASD patients with preoperative PI-LL >20°, L4-S1 lordosis <30°, and full body radiographs and patient-reported outcome measures (PROMs) at baseline and six-week postoperative visit were included. Patients were grouped into ALIF (1-2 level ALIF at L4-S1), PSO (L4/L5 PSO), and TLIF (1-2 level TLIF at L4-S1). Comparative analyses were performed on demographics, radiographic spinopelvic parameters, complications, and PROMs. RESULTS:Among the 96 included patients, 40 underwent ALIF, 27 underwent PSO, and 29 underwent TLIF. At baseline, cohorts had comparable age, sex, race, Edmonton frailty scores and radiographic spinopelvic parameters (p>0.05). However, PSO was performed more often in revision cases (p<0.001). Following surgery, L4-S1 lordosis correction (p=0.001) was comparable among ALIF and PSO patients and caudal lordotic apex migration (p=0.044) was highest among ALIF patients. PSO patients had higher intraoperative estimated blood loss (p<0.001) and motor deficits (p=0.049), and in-hospital ICU admission (p=0.022) and blood products given (p=0.004) but were otherwise comparable in terms of length of stay, blood transfusion given, and postoperative admission to rehab. Likewise, 90-day postoperative complication profiles and six-week PROMs were comparable as well. CONCLUSIONS:ALIF can restore L4-S1 sagittal alignment as powerfully as PSO, with fewer intra-operative and in-hospital complications. When feasible, ALIF is a suitable alternative to PSO and likely superior to TLIF for correcting L4-S1 lordosis among patients with severe sagittal malalignment.
PMID: 38866236
ISSN: 1878-8769
CID: 5669142