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Bassel G. Diebo, Jonathan H. Oren, Vincent Challier, Renaud Lafage, Emmanuelle Ferrero, Shian Liu, Shaleen Vira, Matthew Adam Spiegel, Bradley Yates Harris, Barthelemy Liabaud, Jensen K. Henry, Thomas J. Errico, Frank J. Schwab and Virginie Lafage

OBJECTIVE

Sagittal malalignment requires higher energy expenditure to maintain an erect posture. Because the clinical impact of sagittal alignment is affected by both the severity of the deformity and recruitment of compensatory mechanisms, it is important to investigate new parameters that reflect both disability level and compensatory mechanisms for all patients. This study investigated the clinical relevance of the global sagittal axis (GSA), a novel measure to evaluate the standing axis of the human body.

METHODS

This is a retrospective review of patients who underwent full-body radiographs and completed health-related quality of life (HRQOL) questionnaires: Oswestry Disability Index (ODI), Scoliosis Research Society–22, EuroQol-5D (EQ-5D), and the visual analog scale for back and leg pain. The GSA was defined as the angle formed by a line from the midpoint of the femoral condyles to the center of C-7, and a line from the midpoint between the femoral condyles to the posterior superior corner of the S-1 sacral endplate. After evaluating the correlation of GSA/HRQOL with sagittal parameters, linear regression models were generated to investigate how ODI and GSA related to radiographic parameters (T-1 pelvic angle, pelvic retroversion, knee flexion, and pelvic posterior translation).

RESULTS

One hundred forty-three patients (mean age 44 years) were included. The GSA correlated significantly with all HRQOL (up to r = 0.6 with EQ-5D) and radiographic parameters (up to r = 0.962 with sagittal vertical axis). Regression between ODI and sagittal radiographic parameters identified the GSA as an independent predictor (r = 0.517, r2 = 0.267; p < 0.001). Analysis of standardized coefficients revealed that when controlling for deformity, the GSA increased with a concurrent decrease in pelvic retroversion (−0.837) and increases in knee flexion (+0.287) and pelvic posterior translation (+0.193).

CONCLUSIONS

The GSA is a simple, novel measure to assess the standing axis of the human body in the sagittal plane. The GSA correlated highly with spinopelvic and lower-extremities sagittal parameters and exhibited remarkable correlations with HRQOL, which exceeded other commonly used parameters.

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Alexander A. Theologis, Tamir Ailon, Justin K. Scheer, Justin S. Smith, Christopher I. Shaffrey, Shay Bess, Munish Gupta, Eric O. Klineberg, Khaled Kebaish, Frank Schwab, Virginie Lafage, Douglas Burton, Robert Hart, Christopher P. Ames and The International Spine Study Group

OBJECTIVE

The objective of this study was to isolate whether the effect of a baseline clinical history of depression on outcome is independent of associated physical disability and to evaluate which mental health screening tool has the most utility in determining 2-year clinical outcomes after adult spinal deformity (ASD) surgery.

METHODS

Consecutively enrolled patients with ASD in a prospective, multicenter ASD database who underwent surgical intervention with a minimum 2-year follow-up were retrospectively reviewed. A subset of patients who completed the Distress and Risk Assessment Method (DRAM) was also analyzed. The effects of categorical baseline depression and DRAM classification on the Oswestry Disability Index (ODI), SF-36, and Scoliosis Research Society questionnaire (SRS-22r) were assessed using univariate and multivariate linear regression analyses. The probability of achieving ≥ 1 minimal clinically important difference (MCID) on the ODI based on the DRAM’s Modified Somatic Perceptions Questionnaire (MSPQ) score was estimated.

RESULTS

Of 267 patients, 66 (24.7%) had self-reported preoperative depression. Patients with baseline depression had significantly more preoperative back pain, greater BMI and Charlson Comorbidity Indices, higher ODIs, and lower SRS-22r and SF-36 Physical/Mental Component Summary (PCS/MCS) scores compared with those without self-reported baseline depression. They also had more severe regional and global sagittal malalignment. After adjusting for these differences, preoperative depression did not impact 2-year ODI, PCS/MCS, or SRS-22r totals (p > 0.05). Compared with those in the “normal” DRAM category, “distressed somatics” (n = 11) had higher ODI (+23.5 points), lower PCS (−10.9), SRS-22r activity (−0.9), and SRS-22r total (−0.8) scores (p ≤ 0.01), while “distressed depressives” (n = 25) had lower PCS (−8.4) and SRS-22r total (−0.5) scores (p < 0.05). After adjusting for important covariates, each additional point on the baseline MSPQ was associated with a 0.8-point increase in 2-year ODI (p = 0.03). The probability of improving by at least 1 MCID in 2-year ODI ranged from 77% to 21% for MSPQ scores 0–20, respectively.

CONCLUSIONS

A baseline clinical history of depression does not correlate with worse 2-year outcomes after ASD surgery after adjusting for baseline differences in comorbidities, health-related quality of life, and spinal deformity severity. Conversely, DRAM improved risk stratification of patient subgroups predisposed to achieving suboptimal surgical outcomes. The DRAM’s MSPQ was more predictive than MCS and SRS mental domain for 2-year outcomes and may be a valuable tool for surgical screening.

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Justin S. Smith, Eric Klineberg, Virginie Lafage, Christopher I. Shaffrey, Frank Schwab, Renaud Lafage, Richard Hostin, Gregory M. Mundis Jr., Thomas J. Errico, Han Jo Kim, Themistocles S. Protopsaltis, D. Kojo Hamilton, Justin K. Scheer, Alex Soroceanu, Michael P. Kelly, Breton Line, Munish Gupta, Vedat Deviren, Robert Hart, Douglas C. Burton, Shay Bess, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

Although multiple reports have documented significant benefit from surgical treatment of adult spinal deformity (ASD), these procedures can have high complication rates. Previously reported complications rates associated with ASD surgery are limited by retrospective design, single-surgeon or single-center cohorts, lack of rigorous data on complications, and/or limited follow-up. Accurate definition of complications associated with ASD surgery is important and may serve as a resource for patient counseling and efforts to improve the safety of patient care. The authors conducted a study to prospectively assess the rates of complications associated with ASD surgery with a minimum 2-year follow-up based on a multicenter study design that incorporated standardized data-collection forms, on-site study coordinators, and regular auditing of data to help ensure complete and accurate reporting of complications. In addition, they report age stratification of complication rates and provide a general assessment of factors that may be associated with the occurrence of complications.

METHODS

As part of a prospective, multicenter ASD database, standardized forms were used to collect data on surgery-related complications. On-site coordinators and central auditing helped ensure complete capture of complication data. Inclusion criteria were age older than 18 years, ASD, and plan for operative treatment. Complications were classified as perioperative (within 6 weeks of surgery) or delayed (between 6 weeks after surgery and time of last follow-up), and as minor or major. The primary focus for analyses was on patients who reached a minimum follow-up of 2 years.

RESULTS

Of 346 patients who met the inclusion criteria, 291 (84%) had a minimum 2-year follow-up (mean 2.1 years); their mean age was 56.2 years. The vast majority (99%) had treatment including a posterior procedure, 25% had an anterior procedure, and 19% had a 3-column osteotomy. At least 1 revision was required in 82 patients (28.2%). A total of 270 perioperative complications (145 minor; 125 major) were reported, with 152 patients (52.2%) affected, and a total of 199 delayed complications (62 minor; 137 major) were reported, with 124 patients (42.6%) affected. Overall, 469 complications (207 minor; 262 major) were documented, with 203 patients (69.8%) affected. The most common complication categories included implant related, radiographic, neurological, operative, cardiopulmonary, and infection. Higher complication rates were associated with older age (p = 0.009), greater body mass index (p ≤ 0.031), increased comorbidities (p ≤ 0.007), previous spine fusion (p = 0.029), and 3-column osteotomies (p = 0.036). Cases in which 2-year follow-up was not achieved included 2 perioperative mortalities (pulmonary embolus and inferior vena cava injury).

CONCLUSIONS

This study provides an assessment of complications associated with ASD surgery based on a prospective, multicenter design and with a minimum 2-year follow-up. Although the overall complication rates were high, in interpreting these findings, it is important to recognize that not all complications are equally impactful. This study represents one of the most complete and detailed reports of perioperative and delayed complications associated with ASD surgery to date. These findings may prove useful for treatment planning, patient counseling, benchmarking of complication rates, and efforts to improve the safety and cost-effectiveness of patient care.

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Bong Ju Moon, Justin S. Smith, Christopher P. Ames, Christopher I. Shaffrey, Virginie Lafage, Frank Schwab, Morio Matsumoto, Jong Sam Baik and Yoon Ha

OBJECT

To identify the characteristics of cervical deformities in Parkinson's disease (PD) and the role of severity of PD in the development of cervical spine deformities, the authors investigated the prevalence of the cervical deformities, cervical kyphosis (CK), and cervical positive sagittal malalignment (CPSM) in patients with PD. They also analyzed the association of severity of cervical deformities with the stage of PD in the context of global sagittal spinopelvic alignment.

METHODS

This study was a prospective assessment of consecutively treated patients (n = 89) with PD. A control group of the age- and sex-matched patients was selected from patients with degenerative cervical spine disease but without PD. Clinical and demographic parameters including age, sex, duration of PD, and Hoehn and Yahr (H&Y) stage were collected. Full-length standing radiographs were used to assess spinopelvic parameters. CK was defined as a C2–7 Cobb angle < 0°. CPSM was defined as C2–7 sagittal vertical axis (SVA) > 4 cm.

RESULTS

A significantly higher prevalence of CPSM (28% vs 1.1%, p < 0.001), but not CK (12% vs 10.1%, p = 0.635), was found in PD patients compared with control patients. Among patients with PD, those with CK were younger (62.1 vs 69.0 years, p = 0.013) and had longer duration of PD (56.4 vs 36.2 months, p = 0.034), but the severity of PD was not significantly different. Logistic regression analysis revealed that the presence of CK was associated with younger age, higher mismatch between pelvic incidence and lumbar lordosis, and lower C7–S1 SVA. The patients with CPSM had significantly greater thoracic kyphosis (TK) (p < 0.001) and a trend toward more advanced H&Y stage (p = 0.05). Logistic regression analysis revealed that CPSM was associated with male sex, greater TK, and more advanced H&Y stage.

CONCLUSIONS

Patients with PD have a significantly higher prevalence of CPSM compared with age- and sex-matched control patients with cervical degenerative disease but without PD. Among patients with PD, CK is not associated with the severity of PD but is associated with overall global sagittal malalignment. In contrast, the presence of CPSM is associated more with the severity of PD than it is with the presence of global sagittal malalignment. Collectively, these data suggest that the neuromuscular pathogenesis of PD may affect the development of CPSM more than of CK.

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Emmanuelle Ferrero, Barthelemy Liabaud, Vincent Challier, Renaud Lafage, Bassel G. Diebo, Shaleen Vira, Shian Liu, Jean Marc Vital, Brice Ilharreborde, Themistocles S. Protopsaltis, Thomas J. Errico, Frank J. Schwab and Virginie Lafage

OBJECT

Previous forceplate studies analyzing the impact of sagittal-plane spinal deformity on pelvic parameters have demonstrated the compensatory mechanisms of pelvis translation in addition to rotation. However, the mechanisms recruited for this pelvic rotation were not assessed. This study aims to analyze the relationship between spinopelvic and lower-extremity parameters and clarify the role of pelvic translation.

METHODS

This is a retrospective study of patients with spinal deformity and full-body EOS images. Patients with only stenosis or low-back pain were excluded. Patients were grouped according to T-1 spinopelvic inclination (T1SPi): sagittal forward (forward, > 0.5°), neutral (−6.3° to 0.5°), or backward (< −6.3°). Pelvic translation was quantified by pelvic shift (sagittal offset between the posterosuperior corner of the sacrum and anterior cortex of the distal tibia), hip extension was measured using the sacrofemoral angle (SFA; the angle formed by the middle of the sacral endplate and the bicoxofemoral axis and the line between the bicoxofemoral axis and the femoral axis), and chin-brow vertical angle (CBVA). Univariate and multivariate analyses were used to compare the parameters and correlation with the Oswestry Disability Index (ODI).

RESULTS

In total, 336 patients (71% female; mean age 57 years; mean body mass index 27 kg/m2) had mean T1SPi values of −8.8°, −3.5°, and 5.9° in the backward, neutral, and forward groups, respectively. There were significant differences in the lower-extremity and spinopelvic parameters between T1SPi groups. The backward group had a normal lumbar lordosis (LL), negative SVA and pelvic shift, and the largest hip extension. Forward patients had a small LL and an increased SVA, with a large pelvic shift creating compensatory knee flexion. Significant correlations existed between lower-limb parameter and pelvic shift, pelvic tilt, T-1 pelvic angle, T1SPi, and sagittal vertical axis (0.3 < r < 0.8; p < 0.001). ODI was significantly correlated with knee flexion and pelvic shift.

CONCLUSIONS

This is the first study to describe full-body alignment in a large population of patients with spinal pathologies. Furthermore, patients categorized based on T1SPi were found to have significant differences in the pelvic shift and lower-limb compensatory mechanisms. Correlations between lower-limb angles, pelvic shift, and ODI were identified. These differences in compensatory mechanisms should be considered when evaluating and planning surgical intervention for adult patients with spinal deformity.

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Justin K. Scheer, Peter G. Passias, Alexandra M. Sorocean, Anthony J. Boniello, Gregory M. Mundis Jr., Eric Klineberg, Han Jo Kim, Themistocles S. Protopsaltis, Munish Gupta, Shay Bess, Christopher I. Shaffrey, Frank Schwab, Virginie Lafage, Justin S. Smith, Christopher P. Ames and The International Spine Study Group

OBJECT

A high prevalence of cervical deformity (CD) has been identified among adult patients with thoracolumbar spinal deformity undergoing surgical treatment. The clinical impact of this is uncertain. This study aimed to quantify the differences in patient-reported outcomes among patients with adult spinal deformity (ASD) based on presence of CD prior to treatment.

METHODS

A retrospective review was conducted of a multicenter prospective database of patients with ASD who underwent surgical treatment with 2-year follow-up. Patients were grouped by the presence of preoperative CD: 1) cervical positive sagittal malalignment (CPSM) C2–7 sagittal vertical axis ≥ 4 cm; 2) cervical kyphosis (CK) C2–7 angle > 0; 3) CPSM and CK (BOTH); and 4) no baseline CD (NONE). Health-related quality of life (HRQOL) scores included the Physical Component Summary and Mental Component Summary (PCS and MCS) scores of the 36-Item Short Form Health Survey (SF-36), Oswestry Disability Index (ODI), Scoliosis Research Society-22 questionnaire (SRS-22), and minimum clinically important difference (MCID) of these scores at 2 years. Standard radiographic measurements were conducted for cervical, thoracic, and thoracolumbar parameters.

RESULTS

One hundred eighty-two patients were included in this study: CPSM, 45; CK, 37; BOTH, 16; and NONE, 84. Patients with preoperative CD and those without had similar baseline thoracolumbar radiographic measurements and similar correction rates at 2 years. Patients with and without preoperative CD had similar baseline HRQOL and on average both groups experienced some HRQOL improvement. However, those with preoperative CPSM had significantly worse postoperative ODI, PCS, SRS-22 Activity, SRS-22 Appearance, SRS-22 Pain, SRS-22 Satisfaction, and SRS-22 Total score, and were less likely to meet MCID for ODI, PCS, SRS-22 Activity, and SRS-22 Pain scores with the following ORs and 95% CIs: ODI 0.19 (0.07–0.58), PCS 0.17 (0.06–0.47), SRS-22 Activity 0.23 (0.09–0.62), SRS-22 Pain 0.20 (0.08–0.53), and SRS-22 Appearance 0.34 (0.12–0.94). Preoperative CK did not have an effect on outcomes. Interestingly, despite correction of the thoracolumbar deformity, 53.3% and 51.4% of patients had persistent CPSM and persistent CK, respectively.

CONCLUSIONS

Patients with thoracolumbar deformity without preoperative CD are likely to have greater improvements in HRQOL after surgery than patients with concomitant preoperative CD. Cervical positive sagittal alignment in adult patients with thoracolumbar deformity is strongly associated with inferior outcomes and failure to reach MCID at 2-year follow-up despite having similar baseline HRQOL to patients without CD. This was the first study to assess the impact of concomitant preoperative cervical malalignment in adult patients with thoracolumbar deformity. These results can help surgeons educate patients at risk for inferior outcomes and direct future research to identify an etiology and improve patient outcomes. Investigation into the etiology of the baseline cervical malalignment may be warranted in patients who present with thoracolumbar deformity.

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Michael P. Kelly, Lukas P. Zebala, Han Jo Kim, Daniel M. Sciubba, Justin S. Smith, Christopher I. Shaffrey, Shay Bess, Eric Klineberg, Gregory Mundis Jr., Douglas Burton, Robert Hart, Alex Soroceanu, Frank Schwab, Virginie Lafage and International Spine Study Group

OBJECT

The goal of this study was to examine the effectiveness of preoperative autologous blood donation (PABD) in adult spinal deformity (ASD) surgery.

METHODS

Patients undergoing single-stay ASD reconstructions were identified in a multicenter database. Patients were divided into groups according to PABD (either PABD or NoPABD). Propensity weighting was used to create matched cohorts of PABD and NoPABD patients. Allogeneic (ALLO) exposure, autologous (AUTO) wastage (unused AUTO), and complication rates were compared between groups.

RESULTS

Four hundred twenty-eight patients were identified as meeting eligibility criteria. Sixty patients were treated with PABD, of whom 50 were matched to 50 patients who were not treated with PABD (NoPABD). Nearly one-third of patients in the PABD group (18/60, 30%) did not receive any autologous transfusion and donated blood was wasted. In 6 of these cases (6/60, 10%), patients received ALLO blood transfusions without AUTO. In 9 cases (9/60, 15%), patients received ALLO and AUTO blood transfusions. Overall rates of transfusion of any type were similar between groups (PABD 70% [42/60], NoPABD 75% [275/368], p = 0.438). Major and minor in-hospital complications were similar between groups (Major PABD 10% [6/60], NoPABD 12% [43/368], p = 0.537; Minor PABD 30% [18/60], NoPABD 24% [87/368], p = 0.499). When controlling for potential confounders, PABD patients were more likely to receive some transfusion (OR 15.1, 95% CI 2.1-106.7). No relationship between PABD and ALLO blood exposure was observed, however, refuting the concept that PABD is protective against ALLO blood exposure. In the matched cohorts, PABD patients were more likely to sustain a major perioperative cardiac complication (PABD 8/50 [16%], NoPABD 1/50 [2%], p = 0.046). No differences in rates of infection or wound-healing complications were observed between cohorts.

CONCLUSIONS

Preoperative autologous blood donation was associated with a higher probability of perioperative transfusions of any type in patients with ASD. No protective effect of PABD against ALLO blood exposure was observed, and no risk of perioperative infectious complications was observed in patients exposed to ALLO blood only. The benefit of PABD in patients with ASD remains undefined.

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Christopher P. Ames, Justin S. Smith, Robert Eastlack, Donald J. Blaskiewicz, Christopher I. Shaffrey, Frank Schwab, Shay Bess, Han Jo Kim, Gregory M. Mundis Jr., Eric Klineberg, Munish Gupta, Michael O’Brien, Richard Hostin, Justin K. Scheer, Themistocles S. Protopsaltis, Kai-Ming G. Fu, Robert Hart, Todd J. Albert, K. Daniel Riew, Michael G. Fehlings, Vedat Deviren, Virginie Lafage and International Spine Study Group

OBJECT

Despite the complexity of cervical spine deformity (CSD) and its significant impact on patient quality of life, there exists no comprehensive classification system. The objective of this study was to develop a novel classification system based on a modified Delphi approach and to characterize the intra- and interobserver reliability of this classification.

METHODS

Based on an extensive literature review and a modified Delphi approach with an expert panel, a CSD classification system was generated. The classification system included a deformity descriptor and 5 modifiers that incorporated sagittal, regional, and global spinopelvic alignment and neurological status. The descriptors included: “C,” “CT,” and “T” for primary cervical kyphotic deformities with an apex in the cervical spine, cervicothoracic junction, or thoracic spine, respectively; “S” for primary coronal deformity with a coronal Cobb angle ≥ 15°; and “CVJ” for primary craniovertebral junction deformity. The modifiers included C2–7 sagittal vertical axis (SVA), horizontal gaze (chin-brow to vertical angle [CBVA]), T1 slope (TS) minus C2–7 lordosis (TS–CL), myelopathy (modified Japanese Orthopaedic Association [mJOA] scale score), and the Scoliosis Research Society (SRS)-Schwab classification for thoracolumbar deformity. Application of the classification system requires the following: 1) full-length standing posteroanterior (PA) and lateral spine radiographs that include the cervical spine and femoral heads; 2) standing PA and lateral cervical spine radiographs; 3) completed and scored mJOA questionnaire; and 4) a clinical photograph or radiograph that includes the skull for measurement of the CBVA. A series of 10 CSD cases, broadly representative of the classification system, were selected and sufficient radiographic and clinical history to enable classification were assembled. A panel of spinal deformity surgeons was queried to classify each case twice, with a minimum of 1 intervening week. Inter- and intrarater reliability measures were based on calculations of Fleiss k coefficient values.

RESULTS

Twenty spinal deformity surgeons participated in this study. Interrater reliability (Fleiss k coefficients) for the deformity descriptor rounds 1 and 2 were 0.489 and 0.280, respectively, and mean intrarater reliability was 0.584. For the modifiers, including the SRS-Schwab components, the interrater (round 1/round 2) and intrarater reliabilities (Fleiss k coefficients) were: C2–7 SVA (0.338/0.412, 0.584), horizontal gaze (0.779/0.430, 0.768), TS-CL (0.721/0.567, 0.720), myelopathy (0.602/0.477, 0.746), SRS-Schwab curve type (0.590/0.433, 0.564), pelvic incidence-lumbar lordosis (0.554/0.386, 0.826), pelvic tilt (0.714/0.627, 0.633), and C7-S1 SVA (0.071/0.064, 0.233), respectively. The parameter with the poorest reliability was the C7–S1 SVA, which may have resulted from differences in interpretation of positive and negative measurements.

CONCLUSIONS

The proposed classification provides a mechanism to assess CSD within the framework of global spinopelvic malalignment and clinically relevant parameters. The intra- and interobserver reliabilities suggest moderate agreement and serve as the basis for subsequent improvement and study of the proposed classification.