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Study design: Cohort study.

Objective: To evaluate heterogeneity (fluctuation) in minimal important change (MIC) and patient-acceptable symptom state (PASS) for patient-reported outcomes (PROMs) through 10 years after lumbar fusion.

Summary of background data: PROMs have become key determinants in spine surgery outcomes studies. MIC and PASS were established to aid PROM interpretations. However, their long-term stability has not yet been reported.

Methods: A consecutive series of elective lumbar fusions were followed up using the Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) for pain. Improvement was rated by a 4-point Likert scale into "improved" or "nonimproved." Satisfaction-to-treatment was rated by the patients' willingness to undergo surgery again. Receiver operating characteristics (ROC) curve analysis estimated MIC (95% confidence interval, CI) as the PROM change that best predicted improvement at distinct time-points. PASS (CI) was estimated as the lowest PROM score at which the patients were still satisfied. Heterogeneity across thresholds was evaluated using the DeLong algorithm.

Results: MIC for ODI represented heterogeneity across 10 years, ranging from -21 (-24 to -16) at two years to -8 (-7 to -4) at five years, P<0.001. The areas under the ROC curves (AUCs) (0.79 to 0.85) indicated acceptable to excellent discrimination. Heterogeneity was not significant in the MICs for the pain scores. At one year, MIC for back pain was -24 (-38 to -15), AUC 0.77, and for leg pain, it was -26 (-44 to -8), AUC 0.78. No significant heterogeneity was observed in 10-year PASS scores. At 1-year, PASS for ODI was 22 (15 to 29), AUC 0.85. Similarly, the one-year PASS for back pain was 38 (20 to 56), AUC 0.81, and for leg pain, it was 49 (26 to 72), AUC 0.81.

Conclusions: MIC for ODI fluctuated over 10 years after lumbar fusions. PASS values for all PROMs seemed most stable over time. Caution is needed when generic MIC values are used in long-term studies.

Level of evidence: Level III.

Study design: Retrospective review, single-institution cohort studies.

Objective: To compare patients with earlier ( i.e. <1.5 yr) and later ( i.e . >1.5 yr) repeat lumbar surgery to patients with no repeat surgery according to clinical characteristics at index surgery.

Background: Grouping patients as earlier or later repeat surgery may reveal different associations when compared with patients with no repeat surgery.

Patients and methods: Patients undergoing index surgery for diverse conditions reported preoperative demographic/clinical variables, including comorbidity and depressive symptoms. Extent ( i.e . complexity) of surgery was assigned based on a valid index that included decompression, fusion, and instrumentation. Co-existing disease at nonoperated levels was ascertained from imaging reports. Postoperative records of all medical visits up to the time of this study (12 yr) were reviewed for repeat surgery. Patients were grouped as earlier (<1.5 yr) or later surgery (≥1.5 yr) and compared with patients with no repeat surgery in separate multivariable analyses.

Results: Among 1334 patients (51% men, mean age 59), 82% did not have repeat surgery, 7% had earlier and 11% had later repeat surgery. Compared with no surgery, earlier surgery was associated with more comorbidity (OR: 1.7, CI: 1.1-2.6, P =0.02), positive depression screen (OR: 1.9, CI: 1.2-2.9, P =0.006), opioid use (OR: 1.8, CI: 1.2-2.8, P =0.008), and greater extent of index surgery (OR: 1.1, CI: 1.0-1.1, P =0.0009). Compared with no surgery, later surgery was associated with preindex lumbar surgery (OR: 1.9, CI: 1.3-2.8, P =0.0005) and disease at nonoperated levels at index surgery (OR: 1.6, CI: 1.0-2.4, P =0.05). Earlier surgeries were more likely to involve only the same vertebra as index surgery (51% vs. 16%) and later surgeries were more likely to involve only other levels (5% vs. 36%, P =0.01).

Conclusions: Earlier and later repeat lumbar surgeries differed in complexity and residual disease compared with no repeat surgery. These findings have implications for patient counseling regarding short-term and long-term postoperative spine health.

Study design: Retrospective review of cohort studies.

Objective: To clarify the necessary Oswestry Disability Index (ODI) improvement for patient satisfaction 2 years after lumbar surgery.

Background: Evaluating elective lumbar surgery care often involves patient-reported outcomes. While postoperative functional improvement measured by ODI is theoretically linked to satisfaction, conflicting evidence exists regarding this association.

Material and methods: Baseline ODI and 2-year postoperative ODI were assessed. Patient satisfaction, measured on a scale from 1 to 5, with scores ≥4 considered satisfactory, was evaluated. Patients with incomplete follow-up were excluded. Statistical analyses included Mann-Whitney U and multivariable logistic regression adjusted for age, sex, and body mass index. Receiver operating characteristic analysis determined threshold values for ODI improvement and postoperative target ODI indicative of patient satisfaction.

Results: A total of 383 patients were included (mean age: 65 ± 10 y, 57% females). ODI improvement was observed in 91% of patients, with 77% reporting satisfaction scores ≥4. Baseline ODI (median: 62, interquartile range: 46-74) improved to a median of 10 (interquartile range: 1-10) 2 years postoperatively. Baseline [odds ratio (OR): 0.98, P = 0.015] and postoperative ODI scores (OR: 0.93, P < 0.001), as well as the difference between them (OR: 1.04, P < 0.001), were significantly associated with patient satisfaction. Improvement of ≥38 ODI points or a relative change of ≥66% was indicative of patient satisfaction, with higher sensitivity (80%) and specificity (82%) for the relative change versus the absolute change (69%, 68%). With a sensitivity of 85% and a specificity of 77%, a postoperative target ODI of ≤24 indicated patient satisfaction.

Conclusion: Lower baseline ODI and greater improvements in postoperative ODI are associated with an increased likelihood of patient satisfaction. A relative improvement of ≥66% or achieving a postoperative ODI score of ≤24 were the most indicative thresholds for predicting patient satisfaction, proving more sensitivity and specificity than an absolute change of ≥38 points.

Study design: A retrospective case-control study.

Objectives: This study aimed to compare rates and risk factors for all-cause 5-year revisions for patients undergoing primary single-level cervical disc arthroplasty (CDA) versus anterior cervical discectomy and fusion (ACDF).

Summary of background data: Prospective studies have compared patient-reported outcomes, adjacent segment degeneration, and long-term revisions between CDA and ACDF. Despite these high-level evidence studies, well-powered, large investigations have not been adequately reported.

Patients and methods: A nationwide database was queried for patients undergoing primary single-level CDA or ACDF for degenerative cervical spine pathology. Further inclusion criteria consisted of patients having a minimum 5-year follow-up. Patients undergoing CDA were in a 1:5 ratio matched to patients undergoing ACDF by age, sex, comorbidities, and overall Elixhauser comorbidity index (ECI). Objectives were to compare the rates and risk factors of all-cause 5-year revisions for those undergoing single-level CDA versus ACDF. Multivariate logistic regression models computed the odds ratios (ORs) of revisions within 5 years. P values of less than 0.001 were significant.

Results: A total of 32,953 patients underwent single-level CDA (N=5,640) or ACDF (N=27,313) with a 5-year minimum follow-up. The incidence of all-cause revisions within 5 years was 1.24% for CDA and 9.23% for ACDF ( P <0.001). After adjustment, patients undergoing single-level ACDF had significantly higher odds of all-cause revisions within 5 years (OR: 8.09; P <0.0001). Additional patient-specific factors associated with revisions were a history of reported drug abuse (OR: 1.51; P <0.0001), depression (OR: 1.23; P <0.0001), cardiac arrhythmias (OR: 1.21; P =0.0008), hypertension (OR: 1.20; P =0.0006), and tobacco use (OR: 1.18; P =0.0003).

Conclusions: In this study of nearly 33,000 single-level cervical spine surgeries with minimum 5-year follow-up, all-cause revision rates were significantly lower for patients undergoing CDA. Surgeons may use this data to counsel patients regarding 5-year revisions following single-level CDA or ACDF.

Level of evidence: III.

Study design: Prospective trial comparing the investigation group to propensity-matched historic control group.

Objective: To evaluate five-year results of single-level PEEK-on-ceramic cervical total disc replacement (TDR) compared with a propensity-matched anterior cervical discectomy and fusion (ACDF) control group.

Summary of background data: Cervical TDR has gained acceptance as a treatment for symptomatic disk degeneration. The design and materials used in these devices continue to evolve.

Materials and methods: Data were collected in the Food and Drug Administration Investigational Device Exemption trial for the PEEK-on-ceramic Simplify Cervical Artificial Disc (n=150) with comparison to a propensity-matched ACDF control group (n=117). All patients were treated for single-level cervical disk degeneration with radiculopathy and/or myelopathy. Clinical outcome was based on composite clinical success (CCS), Neck Disability Index (NDI), visual analog scales (VAS) assessing pain, reoperations, and satisfaction. Radiographic measures included segmental range of motion (ROM), disk space height, and heterotopic ossification (HO). Evaluations were performed preoperatively and postoperatively within two and six weeks, and three, six, 12 months, and annually thereafter.

Results: At five-year follow-up, CCS was significantly greater with TDR than ACDF (91.1% vs. 74.6%; P <0.01). In the TDR group, the mean NDI score was 63.3 preoperatively, reduced significantly to 23.1 at six weeks, and remained below 20 throughout the five-year follow-up. In the ACDF group, the mean preoperative NDI score was 62.4, decreasing to 33.7 at six weeks, and ranged from 25.9 to 21.5 throughout follow-up. Mean NDI scores were significantly lower in TDR group at all postoperative points ( P <0.05). Mean TDR ROM was 7.3 o preoperatively and 10.1 o at five years. Bridging HO occurred in 9%. With TDR, there were six reoperations (4.0%) versus 11 (9.4%) with ACDF ( P >0.40).

Conclusions: PEEK-on-ceramic TDR produced significantly improved outcomes maintained throughout five-year follow-up that were similar or superior to ACDF, supporting TDR in appropriately selected patients.

Background: Recent studies highlight the increasing adoption of single-position prone lateral(SP-PL) and single-position lateral decubitus(SP-LD) in Minimally Invasive Spine Surgery(MISS) to reduce operative time, enhance patient safety, and improve surgical accessibility.

Objective: To assess the differences between SP-PL and SP-LD achievement of optimal postoperative outcomes and post-operative complication rates.

Study design: Retrospective review of prospectively collected MIS database.

Methods: Consecutive series of 152 Patients with baseline(BL) and 1-year(1Y) postoperative radiographic/HRQL data were included. Patients placed in the SP-PL or SP-LD were isolated. Optimal Outcome(OO) was defined as patients who experienced no complication requiring reoperation and achieved Substantial Clinical Benefit(SCB) for NRS-leg or NRS-back. Means comparison analysis assessed differences in radiographic and clinical outcomes. ANCOVA and multivariable backward stepwise logistic regression were used to adjust for confounders.

Results: 59 SP-PL and 93 SP-LD patients were included. At baseline, cohorts were comparable in terms of age, gender, BMI, and CCI. Peri-operatively, SP-PL patients had a significantly lower operative time(207.22 vs. 317.5 min;P<0.001), LOS(3.1 vs. 3.6 days;P=0.033), EBL(244.5 vs. 376.3 mL;P=0.023), and demonstrated lower perioperative complication rate(25.4% vs. 41.9%;P=0.038). Multivariable analysis indicated that SP-PL patients had a lower likelihood of cardiac perioperative complications(OR 0.012;CI95%: 0.0-0.6;P=0.026). Immediate postoperatively, SP-PL has a greater degree of segmental lordosis improvement from L1-L2 to L5-S1(all;P<0.05). SP-PL patients have a higher likelihood of achieving SCB NRS-Back at 1Y(OR: 8.0;CI95%: 1.5-42.0;P=0.014) and MCID NRS-leg at 1Y(OR:4.6;CI95%:1.002-21.2;P=0.49). The SP-PL cohort had a significantly greater percentage of OO(96.6% vs. 78.5%;P=0.002) and a higher likelihood of achieving OO in adjusted analysis (OR:10.6;CI95%: 2.1-53.3;P=0.004).

Conclusions: Patients placed in the SP-PL during minimally invasive spine surgery exhibit a reduced rate of perioperative complications, higher incidence of SCB, and a superior rate of achieving optimal outcome at the one-year follow-up. These findings underscore the SP-PL position as a potentially advantageous approach for minimally invasive lumbar fusion.

Study design: Retrospective cohort study.

Objective: To evaluate inpatient complication profiles of patients receiving neuromuscular blockade reversal via sugammadex versus neostigmine/glycopyrrolate.

Summary of background data: Sugammadex is a neuromuscular blockade reversal agent that binds non-depolarizing muscle relaxants. This is a different mechanism from traditional reversal agents such as the combination drug neostigmine (acetylcholinesterase inhibitor)/glycopyrrolate (antimuscarinic agent). Sugammadex has theoretical advantages related to more predictable and rapid reversal, and decreased autonomic side effects. While these agents have been compared in non-spine literature, there is minimal research examining their impact during prone lumbar fusion.

Methods: All adult patients who underwent a primary one- or two-level posterior lumbar fusion (L4-S1) at a single academic center (2018-2021) were retrospectively identified. Neuromuscular blockade reversal agents (sugammadex or NG), demographics, surgical characteristics, and surgical outcomes were collected through a Structured Query Language search and confirmed by chart review. Bivariate analysis and multivariate linear regression were performed. Alpha was set at P<0.05.

Results: In the NG group, more patients had ≥1 inpatient complication (31.2% vs. 19.9%, P=0.012) and cardiac complication (19.1% vs. 11.3%, P=0.040). NG had higher total (0.40±0.66 vs. 0.28±0.62, P=0.046) and cardiac (0.23±0.50 vs. 0.13±0.37, P=0.009) complication rates per person. Operative time was longer amongst patients reversed with NG (182±55.9 vs. 174±55.9, P=0.039). Multivariable linear regression for inpatient complications demonstrated that sugammadex (estimate=-0.124, P=0.045) was negatively predictive of inpatient complications, while Elixhauser (estimate=0.073, P<0.001) was positively predictive.

Conclusion: The current results demonstrate that sugammadex may create less risk for cardiac complications, and is likely associated with more rapid reversal and decreased OR time during prone lumbar fusion. However, additional research is needed to further validate these findings, especially amongst patients with cardiac comorbidities.