RESUMEN

STUDY DESIGN: Retrospective case series. OBJECTIVE: To evaluate the short- and long-term treatment effect (TE) of spinopelvic parameters after surgical correction of adult spine deformity (ASD) utilizing preoperative planning and patient-specific spine rods (PSSRs), and to assess the correspondence between planned and real outcomes. SUMMARY OF BACKGROUND DATA: PSSR have been used in ASD correction for the last decade. However, a TE and predictability of spinopelvic alignment at long-term follow-up has not been studied. METHODS: Inclusion criteria: male or female; age more than 20 years; correction of ASD with PSSR; 24-month follow-up (or revision surgery). Studied parameters: sagittal vertical axis; lumbar lordosis (LL); pelvic tilt (PT); sacral slope; pelvic incidence (PI); and PI-LL. The measurement error, TE (the differences between postoperative and preoperative values), standardized TE, and predictability of the studied parameters assessed. The variables included categorical (optimal/nonoptimal) and continuous obtained by direct measurements and weighted by individual optimal values. Statistical significance was set at P ≤ 0.05. RESULTS: Thirty-four patients were included: 56% women; the mean age, 63.4 (standard deviation, 12.7); at each follow-up: 32 at 1 to 3 months, 34 at 11 to 13, and 14 at 23 to 25 with 9 followed to the revision surgery. Strong or moderate TE was shown for sagittal vertical axis, LL, and PI-LL. The TE of PT and sacral slope was less significant and lower than planned. PI was not stable in 18%. The changes of continuous variables were more prominent and statistically significant then categorical. The mean values did not show significant differences between planned and postoperative outcomes except for PT. However, the individual deviations were substantial for all parameters. Significant predictability was shown only for LL and PI. CONCLUSION: Use of PSSR showed strong and relatively stable TE in ASD during 2 postoperative years. However, improvement of the planning accuracy may contribute to further enhancement of the method's efficacy. LEVEL OF EVIDENCE: 4.

Asunto(s)

Fijadores Internos/tendencias , Lordosis/diagnóstico por imagen , Lordosis/cirugía , Vértebras Lumbares/diagnóstico por imagen , Vértebras Lumbares/cirugía , Huesos Pélvicos/diagnóstico por imagen , Reoperación/tendencias , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Reoperación/instrumentación , Reoperación/métodos , Estudios Retrospectivos , Fusión Vertebral/instrumentación , Fusión Vertebral/métodos , Resultado del Tratamiento , Adulto Joven

RESUMEN

STUDY DESIGN: A systematic review with meta-analysis. OBJECTIVE: To combine published data, focusing on the development of optimal spinopelvic parameters in adult asymptomatic subjects without spine deformity while taking into consideration the impact of potential confounders. SUMMARY OF BACKGROUND DATA: A well-grounded approach to define the optimal spinopelvic parameters is necessary for planning surgical correction of spine deformity. MATERIALS: Selection criteria: (1) randomized and nonrandomized prospective, cross-sectional, and retrospective studies; (2) participants: asymptomatic subjects without spine deformity aged above 18 years; (3) studied parameters: lumbar lordosis (LL), pelvic incidence, sacral slope, and pelvic tilt; (4) potential confounders: method of measurement, sex, age, ethnicity, weight, height, and body mass index. Search method: Ovid MEDLINE (1946-current) and EMBASE (1980-current), all years through October 2015 were included. Data were collected: number of enrolled subjects, means of the studied characteristics, SD, SE of the means, 95% confidence intervals. A meta-analysis was performed to evaluate the pooled means and range of optimal values (pooled mean±pooled SD) taking into consideration the impact of confounders. The GRADE approach was applied to evaluate the level of evidence. RESULTS: Seventeen of 1018 studies were included (2926 subjects from 9 countries). The pooled means and the optimal ranges were: LL (L1-S1), 54.6 (42-67) degrees; LL (L1-L5), 37.0 (22-53) degrees; pelvic incidence, 50.6 (39-62) degrees; sacral slope, 37.7 (28-48) degrees; pelvic tilt, 12.6 (3-22) degrees. The pooled results were statistically significant (P<0.001), but heterogeneous. Impact of the following confounders was revealed: method of measurement, ethnicity, age, and body mass index. A methodology was created to define an individualized optimal value and range of each studied parameter taking into consideration the influence of confounders. CONCLUSIONS: The pooled results and developed methodology can be used as diagnostic criteria for evaluation of the spinopelvic parameters, planning of surgical interventions and evaluation of the treatment effect.

Asunto(s)

Pelvis/patología , Enfermedades de la Columna Vertebral/patología , Columna Vertebral/anomalías , Humanos , Sesgo de Publicación , Análisis de Regresión

RESUMEN

STUDY DESIGN: Meta-analysis of 4 randomized controlled clinical trials (RCTs). OBJECTIVE: The aim of the study was to determine if patients with degenerative disc disease who achieve radiographic fusion after single-level lumbar interbody arthrodesis have better clinical outcomes than patients with radiographic pseudarthrosis at 12 and 24 months postoperative. SUMMARY OF BACKGROUND DATA: The clinical relevance of successful fusion after lumbar arthrodesis with recombinant human bone morphogenetic protein-2 or iliac crest bone autograft has recently been questioned in the literature. METHODS: Individual patient-level data of 4 RCTs were obtained from the Yale University Open Data Access Project project and analyzed. Clinical outcomes (Oswestry Disability Index [ODI]; Numeric Rating Scales [NRSs] for back and leg pain) were compared between patients with radiographically confirmed fusion and those with radiographic nonunion 1 and 2 years postoperative. The results of each study were first analyzed separately, and then were pooled by meta-analysis. The GRADE approach was applied to evaluate the level of evidence. RESULTS: A total of 496 patients with clinical and radiographic data at 1- and 2-year follow-ups were identified. Of these, 5.5% (95% confidence interval: 3.7; 8.3) had radiographic nonunion which did not require reoperation. Patients with fusion had better improvements in ODI (P < 0.001) and NRS back pain scores (P < 0.001). The overall percentage of fused patients with ODI and NRS back pain scores that exceeded the criteria for minimal clinically important differences was also significantly higher than that of patients with nonunion (ODI, odds ratio [OR] = 2.7, P = 0.019; NRS back pain, OR = 3.5, P = 0.033). The predictive values of fusion for clinical outcomes, however, were poor, with low specificity and low negative predictive values. CONCLUSION: The presence of radiographic fusion is clinically significant, as patients with fusion had better clinical outcomes at 1 and 2 years postoperative than those with nonunion; however, patient-centered clinical outcomes should also be taken into consideration as independent, complimentary variables when assessing treatment success.

Asunto(s)

Artrodesis/métodos , Artrodesis/estadística & datos numéricos , Degeneración del Disco Intervertebral/cirugía , Vértebras Lumbares/diagnóstico por imagen , Vértebras Lumbares/cirugía , Adulto , Dolor de Espalda , Bases de Datos Factuales , Femenino , Humanos , Degeneración del Disco Intervertebral/diagnóstico por imagen , Degeneración del Disco Intervertebral/epidemiología , Vértebras Lumbares/patología , Masculino , Persona de Mediana Edad , Radiografía

RESUMEN

STUDY DESIGN: Systematic review with meta-analysis. OBJECTIVE: To (1) evaluate long-term patient-centered clinical outcomes after lumbar arthrodesis with or without decompression for lumbar spondylosis (LS); and (2) compare these outcomes with those of alternative treatments, including nonsurgical and surgical which maintain mobility of the lumbar spine. SUMMARY OF BACKGROUND DATA: The effective treatment of LS is a complex clinical and economic concern for patients and health care providers. SELECTION CRITERIA: (1) randomized controlled clinical trials (RCTs) comparing treatment effects of lumbar arthrodesis with other interventions; (2) participants: skeletally mature adults with lumbar degenerative disk disease. SEARCH METHODS: Ovid MEDLINE, Embase, the Cochrane Library, and others. All years through February of 2013 were included. Patient-centered clinical outcomes before treatment, at 12, 24, or >24 months of follow-up, and rate of complications and additional surgical treatment were collected. A meta-analysis was performed to evaluate pooled treatment effects. The GRADE approach was applied to evaluate the level of evidence. RESULTS: The review included 38 studies of 5738 participants. All studies showed strong or at least moderate treatment effects of lumbar arthrodesis at 12, 24, and 48-72 months of follow-up. The level of evidence was moderate at 12 and 24 months, and low at 48-72 months. The pooled long-term treatment effect of lumbar arthrodesis exceeded those of: nonsurgical treatment (P<0.0001) with a moderate level of evidence, and decompression without fusion (P=0.005) with a low level of evidence. The treatment effect of lumbar arthrodesis showed a small inferiority versus arthroplasty at 12 and 24 months of follow-up (P<0.001), but not after 24 months postoperative. CONCLUSIONS: This review indicates that surgical stabilization of the lumbar spine is an effective treatment for LS; in particular, for patients with severe chronic low back pain that has been resistant to ≥3 months of conservative therapy.

Asunto(s)

Artrodesis/métodos , Degeneración del Disco Intervertebral/cirugía , Humanos , Dolor de la Región Lumbar/etiología , Evaluación del Resultado de la Atención al Paciente , Sesgo de Publicación , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento

RESUMEN

STUDY DESIGN: Systematic review with meta-analysis. OBJECTIVES: To compare the perioperative and long-term postoperative effectiveness of bone morphogenetic protein (BMP) for lumbar arthrodesis in skeletally mature adults with degenerative disk disease (DDD) to that of the current golden standard treatment, iliac crest autologous bone graft (ICBG). SUMMARY OF BACKGROUND DATA: The treatment efficacy of lumbar arthrodesis in DDD is a complex clinical and economic issue for patients and health care providers. METHODS: Comprehensive electronic literature search was performed using following databases: Ovid MEDLINE; Embase; Cochrane Library; Central Register of Controlled Trials (CENTRAL); Database of Abstracts of Reviews of Effects; Methodology Register; Technology Assessment Database; and Economic Evaluation Database. The full year ranges of each database until May of 2012 were included. RESULTS: Eight randomized controlled clinical trials of 383 citations were selected. The included studies involved 1138 participants. The pooled 2-year postoperative clinical outcomes were equivalent in BMP and ICBG groups, and exceeded minimum clinically important differences for Oswestry Disability Index, SF-36 (physical scale), and numeric rating scale (back pain). ICBG was associated with increased pain and complications at the donor site (P<0.01). The pooled average operative time was 21 minutes less in BMP versus ICBG (P<0.001). The pooled rate of additional surgical treatment was 2 times less in the BMP than in the ICBG groups (P=0.006). The pooled risk of nonunion at 24-month follow-up was 2 times less in the BMP than in the ICBG groups (P=0.037), however, this effect was likely biased. CONCLUSIONS: BMP, in particular rhBMP-2, is a good alternative to autogenous bone graft, especially in cases when harvesting of autologous bone is contraindicated or undesirable, operation time is limited, and there are no contraindications for BMP use.However, the current study did not reveal evidence robust enough to develop strong medical recommendations concerning BMP use for lumbar arthrodesis in degenerative disk disease.

Asunto(s)

Proteínas Morfogenéticas Óseas/uso terapéutico , Trasplante Óseo , Ilion/trasplante , Degeneración del Disco Intervertebral/tratamiento farmacológico , Vértebras Lumbares/cirugía , Atención Perioperativa , Fusión Vertebral/métodos , Adulto , Anciano , Autoinjertos , Proteínas Morfogenéticas Óseas/farmacología , Femenino , Estudios de Seguimiento , Humanos , Ilion/efectos de los fármacos , Degeneración del Disco Intervertebral/cirugía , Vértebras Lumbares/efectos de los fármacos , Región Lumbosacra/cirugía , Masculino , Persona de Mediana Edad , Tempo Operativo , Complicaciones Posoperatorias/etiología , Sesgo de Publicación , Proteínas Recombinantes/uso terapéutico , Fusión Vertebral/efectos adversos , Encuestas y Cuestionarios , Factor de Crecimiento Transformador beta , Resultado del Tratamiento