Browsing by Subject "Pseudarthrosis"
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Item Open Access Changes in radiographic and clinical outcomes with primary treatment adult spinal deformity surgeries from two years to three- to five-years follow-up.(Spine, 2010-09) Bridwell, Keith H; Baldus, Christine; Berven, Sigurd; Edwards, Charles; Glassman, Steven; Hamill, Christopher; Horton, William; Lenke, Lawrence G; Ondra, Stephen; Schwab, Frank; Shaffrey, Christopher; Wootten, DavidStudy design
Retrospective analysis of data entered prospectively into a multicenter database-clinical and radiographic outcomes assessment.Objective
Our hypothesis is that between the 2-year and the 3- to 5-year points surgically treated adult spinal deformity patients will show significant reduction in outcomes by Scoliosis Research Society (SRS), Oswestry Disability Index (ODI), and numerical rating scale back and leg pain scores and will show increasing thoracic kyphosis, loss of lumbar lordosis, and loss of coronal and sagittal balance.Summary of background data
Most analyses of primary presentation adult spinal deformity surgery assess 2-year follow-up. However, it is established that in some patients unfavorable events occur between the 2-year and 5-year points.Methods
The cohort of 113 patients entered into a multicenter database with complete preoperative, 2-year, and 3- to 5-year data. All patients who had adult spinal deformity and surgical treatment represented their first reconstruction. Diagnoses were scoliosis (82.5%), kyphosis (10%), and scoliosis and kyphosis combined (7.5%). Outcome measures and basic radiographic parameters (curve size, thoracic and lumbar sagittal plane, coronal and sagittal balance) were assessed at those 3 time intervals. Complications (pseudarthrosis/implant failure, infection, and junctional deformities) were assessed at the 2-year and the 3- to 5-year (mean, 3.76 years) points. RESULTS.: The mean major curve Cobb angle (preoperative, 57°; 2-year, 29°; 3-5 year, 26°); thoracic kyphosis T5 to T12 (30°, 31°, 32°) and lumbar lordosis T12 to sacrum (48°, 49°, 51°) did not change from the 2-year to ultimate follow-up. Likewise, coronal and sagittal balance parameters were the same at 2-year and ultimate follow-up. SRS total scores and modified ODI were similar at the 2 year and final follow-up (SRS: 3.89-3.88; ODI: 19-18). Preoperative SRS total score was 3.17. Six patients demonstrated complications at the 2-year point and additional 9 patients demonstrated complications at the 3- to 5-year point. Those 9 patients with complications at ultimate follow-up demonstrated significant deterioration in their ODI and SRS scores when compared with the patients who did not have complications at ultimate follow-up.Conclusion
Contrary to our hypothesis, we could not establish deterioration in mean radiographic or clinical outcomes between the 2-year and 3- to 5-year follow-up points when analyzing the group as a whole. However, for the 9 patients who experienced complications between 3- and 5-year follow-up, their outcomes were significantly worse than for the other 104 patients.One should not anticipate an overall radiographic and clinical deterioration of the outcomes of surgically treated primary presentation adult spinal deformity patients in this studied time interval. However, close to 10% of patients will experience a new complication at the 3- to 5-year point, most commonly implant failure/nonunion and/or junctional kyphosis, which will negatively effect the patient-reported outcome.Item Open Access Cost-Utility Analysis of rhBMP-2 Use in Adult Spinal Deformity Surgery.(Spine, 2020-07) Jain, Amit; Yeramaneni, Samrat; Kebaish, Khaled M; Raad, Micheal; Gum, Jeffrey L; Klineberg, Eric O; Hassanzadeh, Hamid; Kelly, Michael P; Passias, Peter G; Ames, Christopher P; Smith, Justin S; Shaffrey, Christopher I; Bess, Shay; Lafage, Virginie; Glassman, Steve; Carreon, Leah Y; Hostin, Richard A; International Spine Study GroupStudy design
Economic modeling of data from a multicenter, prospective registry.Objective
The aim of this study was to analyze the cost utility of recombinant human bone morphogenetic protein-2 (BMP) in adult spinal deformity (ASD) surgery.Summary of background data
ASD surgery is expensive and presents risk of major complications. BMP is frequently used off-label to reduce the risk of pseudarthrosis.Methods
Of 522 ASD patients with fusion of five or more spinal levels, 367 (70%) had at least 2-year follow-up. Total direct cost was calculated by adding direct costs of the index surgery and any subsequent reoperations or readmissions. Cumulative quality-adjusted life years (QALYs) gained were calculated from the change in preoperative to final follow-up SF-6D health utility score. A decision-analysis model comparing BMP versus no-BMP was developed with pseudarthrosis as the primary outcome. Costs and benefits were discounted at 3%. Probabilistic sensitivity analysis was performed using mixed first-order and second-order Monte Carlo simulations. One-way sensitivity analyses were performed by varying cost, probability, and QALY estimates (Alpha = 0.05).Results
BMP was used in the index surgery for 267 patients (73%). The mean (±standard deviation) direct cost of BMP for the index surgery was $14,000 ± $6400. Forty patients (11%) underwent revision surgery for symptomatic pseudarthrosis (BMP group, 8.6%; no-BMP group, 17%; P = 0.022). The mean 2-year direct cost was significantly higher for patients with pseudarthrosis ($138,000 ± $17,000) than for patients without pseudarthrosis ($61,000 ± $25,000) (P < 0.001). Simulation analysis revealed that BMP was associated with positive incremental utility in 67% of patients and considered favorable at a willingness-to-pay threshold of $150,000/QALY in >52% of patients.Conclusion
BMP use was associated with reduction in revisions for symptomatic pseudarthrosis in ASD surgery. Cost-utility analysis suggests that BMP use may be favored in ASD surgery; however, this determination requires further research.Level of evidence
2.Item Open Access Depression and outcome.(Journal of neurosurgery. Spine, 2014-08) Shaffrey, Christopher I; Smith, Justin SItem Open Access Development of a validated computer-based preoperative predictive model for pseudarthrosis with 91% accuracy in 336 adult spinal deformity patients.(Neurosurgical focus, 2018-11) Scheer, Justin K; Oh, Taemin; Smith, Justin S; Shaffrey, Christopher I; Daniels, Alan H; Sciubba, Daniel M; Hamilton, D Kojo; Protopsaltis, Themistocles S; Passias, Peter G; Hart, Robert A; Burton, Douglas C; Bess, Shay; Lafage, Renaud; Lafage, Virginie; Schwab, Frank; Klineberg, Eric O; Ames, Christopher P; International Spine Study GroupOBJECTIVEPseudarthrosis can occur following adult spinal deformity (ASD) surgery and can lead to instrumentation failure, recurrent pain, and ultimately revision surgery. In addition, it is one of the most expensive complications of ASD surgery. Risk factors contributing to pseudarthrosis in ASD have been described; however, a preoperative model predicting the development of pseudarthrosis does not exist. The goal of this study was to create a preoperative predictive model for pseudarthrosis based on demographic, radiographic, and surgical factors.METHODSA retrospective review of a prospectively maintained, multicenter ASD database was conducted. Study inclusion criteria consisted of adult patients (age ≥ 18 years) with spinal deformity and surgery for the ASD. From among 82 variables assessed, 21 were used for model building after applying collinearity testing, redundancy, and univariable predictor importance ≥ 0.90. Variables included demographic data along with comorbidities, modifiable surgical variables, baseline coronal and sagittal radiographic parameters, and baseline scores for health-related quality of life measures. Patients groups were determined according to their Lenke radiographic fusion type at the 2-year follow-up: bilateral or unilateral fusion (union) or pseudarthrosis (nonunion). A decision tree was constructed, and internal validation was accomplished via bootstrapped training and testing data sets. Accuracy and the area under the receiver operating characteristic curve (AUC) were calculated to evaluate the model.RESULTSA total of 336 patients were included in the study (nonunion: 105, union: 231). The model was 91.3% accurate with an AUC of 0.94. From 82 initial variables, the top 21 covered a wide range of areas including preoperative alignment, comorbidities, patient demographics, and surgical use of graft material.CONCLUSIONSA model for predicting the development of pseudarthrosis at the 2-year follow-up was successfully created. This model is the first of its kind for complex predictive analytics in the development of pseudarthrosis for patients with ASD undergoing surgical correction and can aid in clinical decision-making for potential preventative strategies.Item Open Access Effect of Serious Adverse Events on Health-related Quality of Life Measures Following Surgery for Adult Symptomatic Lumbar Scoliosis.(Spine, 2019-09) Smith, Justin S; Shaffrey, Christopher I; Kelly, Michael P; Yanik, Elizabeth L; Lurie, Jon D; Baldus, Christine R; Edwards, Charles; Glassman, Steven D; Lenke, Lawrence G; Boachie-Adjei, Oheneba; Buchowski, Jacob M; Carreon, Leah Y; Crawford, Charles H; Errico, Thomas J; Lewis, Stephen J; Koski, Tyler; Parent, Stefan; Kim, Han Jo; Ames, Christopher P; Bess, Shay; Schwab, Frank J; Bridwell, Keith HStudy design
Secondary analysis of prospective multicenter cohort.Objective
To assess effect of serious adverse events (SAEs) on 2- and 4-year patient-reported outcomes measures (PROMs) in patients surgically treated for adult symptomatic lumbar scoliosis (ASLS).Summary of background data
Operative treatment for ASLS can improve health-related quality of life, but has high rates of SAEs. How these SAEs effect health-related quality of life remain unclear.Methods
The ASLS study assessed operative versus nonoperative ASLS treatment, with randomized and observational arms. Patients were 40- to 80-years-old with ASLS, defined as lumbar coronal Cobb ≥30° and Oswestry Disability Index (ODI) ≥20 or Scoliosis Research Society-22 (SRS-22) ≤4.0 in pain, function, and/or self-image domains. SRS-22 subscore and ODI were compared between operative patients with and without a related SAE and nonoperative patients using an as-treated analysis combining randomized and observational cohorts.Results
Two hundred eighty-six patients were enrolled, and 2- and 4-year follow-up rates were 90% and 81%, respectively, although at the time of data extraction not all patients were eligible for 4-year follow-up. A total of 97 SAEs were reported among 173 operatively treated patients. The most common were implant failure/pseudarthrosis (n = 25), proximal junctional kyphosis/failure (n = 10), and minor motor deficit (n = 8). At 2 years patients with an SAE improved less than those without an SAE based on SRS-22 (0.52 vs. 0.79, P = 0.004) and ODI (-11.59 vs. -17.34, P = 0.021). These differences were maintained at 4-years for both SRS-22 (0.51 vs. 0.86, P = 0.001) and ODI (-10.73 vs. -16.69, P = 0.012). Despite this effect, patients sustaining an operative SAE had greater PROM improvement than nonoperative patients (P<0.001).Conclusion
Patients affected by SAEs following surgery for ASLS had significantly less improvement of PROMs at 2- and 4-year follow-ups versus those without an SAE. Regardless of SAE occurrence, operatively treated patients had significantly greater improvement in PROMs than those treated nonoperatively.Level of evidence
2.Item Open Access Kickstand Rod Technique for Correcting Coronal Imbalance in Adult Scoliosis: 2-Dimensional Operative Video.(Operative neurosurgery (Hagerstown, Md.), 2020-08) Buell, Thomas J; Buchholz, Avery L; Mazur, Marcus D; Mullin, Jeffrey P; Chen, Ching-Jen; Sokolowski, Jennifer D; Yen, Chun-Po; Shaffrey, Mark E; Shaffrey, Christopher I; Smith, Justin SRestoration of spinal alignment and balance is a major goal of adult scoliosis surgery. In the past, sagittal alignment has been emphasized and was shown to have the greatest impact on functional outcomes. However, recent evidence suggests the impact of coronal imbalance on pain and functional outcomes has likely been underestimated.1,2 In addition, iatrogenic coronal imbalance may be common and frequently results from inadequate correction of the lumbosacral fractional curve.2,3 The "kickstand rod" is a recently described technique to achieve and maintain significant coronal-plane correction.4 Also, of secondary benefit, the kickstand rod may function as an accessory supplemental rod to offload stress and bolster primary instrumentation. This may reduce occurrence of rod fracture (RF) or pseudarthrosis (PA).5 Briefly, this technique involves positioning the kickstand rod on the side of coronal imbalance (along the major curve concavity or fractional curve convexity in our video demonstration). The kickstand rod spans the thoracolumbar junction proximally to the pelvis distally and is secured with an additional iliac screw placed just superior to the primary iliac screw. By using the iliac wing as a base, powerful distraction forces can reduce the major curve to achieve more normal coronal balance. This operative video illustrates the technical nuances of utilizing the kickstand rod technique for correction of severe lumbar scoliosis and coronal malalignment in a 60-yr-old male patient. Alignment correction was achieved and maintained without evidence of RF/PA after nearly 6 mo postoperatively. The patient gave informed consent for surgery and to use imaging for medical publication.Item Open Access Outcomes and complications of extension of previous long fusion to the sacro-pelvis: is an anterior approach necessary?(World neurosurgery, 2013-01) Fu, Kai-Ming G; Smith, Justin S; Burton, Douglas C; Shaffrey, Christopher I; Boachie-Adjei, Oheneba; Carlson, Brandon; Schwab, Frank J; Lafage, Virginie; Hostin, Richard; Bess, Shay; Akbarnia, Behrooz A; Mundis, Greg; Klineberg, Eric; Gupta, Munish; International Spine Study GroupBackground
Patients with previous multilevel spinal fusion may require extension of the fusion to the sacro-pelvis. Our objective was to evaluate the outcomes and complications of these patients, stratified based on whether the revision was performed using a posterior-only spinal fusion (PSF) or combined anterior-posterior spinal fusion (APSF).Methods
A retrospective, multicenter evaluation of adults (>18 years old) with a history of prior spinal fusion for scoliosis (≥4 levels) terminating in the distal lumbar spine requiring extension of fusion to the sacro-pelvis (including iliac fixation in all cases), with minimum 2-year follow-up, was performed. Patients were stratified based on approach (APSF vs. PSF) and inclusion of pedicle subtraction osteotomy (PSO). The PSF group included patients treated with an anterior interbody fusion done through a posterior approach, whereas patients in the APSF group all had both anterior and posterior surgical approaches. Clinical outcomes were based on the Scoliosis Research Society (SRS-22) questionnaire.Results
Between 1995 and 2006, 45 patients (mean age = 49 years) met inclusion criteria, with a mean follow-up of 41.9 months (range 24 to 135 months). Demographic, preoperative, operative, and postoperative radiographic, SRS-22, and follow-up results were similar between APSF (n=30) and PSF (n=15) groups. The APSF group had more complications (13 of 30 vs. 3 of 15) and a greater number of pseudarthrosis (4 of 30 vs. 0 of 15) than the PSF group; however, these differences did not reach statistical significance. Patients treated with a PSO (n=13) had greater sagittal vertical axis correction (7.7 cm vs. 2.2 cm; P=.04) compared with patients not treated with a PSO (n=32). There were no differences in complication rates or follow-up SRS-22 scores based on whether a PSO was performed (P>.05).Conclusions
Among adults with previously treated scoliosis requiring extension to the sacro-pelvis, PSF produced radiographic fusion and clinical outcomes equivalent to APSF, whereas complication rates may be lower. PSO resulted in greater sagittal plane correction, without an increase in overall complication rates.Item Open Access Pseudarthrosis in adult and pediatric spinal deformity surgery: a systematic review of the literature and meta-analysis of incidence, characteristics, and risk factors.(Neurosurgical review, 2019-06) How, Nathan E; Street, John T; Dvorak, Marcel F; Fisher, Charles G; Kwon, Brian K; Paquette, Scott; Smith, Justin S; Shaffrey, Christopher I; Ailon, TamirWe conducted a systematic review with meta-analysis and qualitative synthesis. This study aims to characterize pseudarthrosis after long-segment fusion in spinal deformity by identifying incidence rates by etiology, risk factors for its development, and common features. Pseudarthrosis can be a painful and debilitating complication of spinal fusion that may require reoperation. It is poorly characterized in the setting of spinal deformity. The MEDLINE, EMBASE, and Cochrane databases were searched for clinical research including spinal deformity patients treated with long-segment fusions reporting pseudarthrosis as a complication. Meta-analysis was performed on etiologic subsets of the studies to calculate incidence rates for pseudarthrosis. Qualitative synthesis was performed to identify characteristics of and risk factors for pseudarthrosis. The review found 162 articles reporting outcomes for 16,938 patients which met inclusion criteria. In general, the included studies were of medium to low quality according to recommended reporting standards and study design. Meta-analysis calculated an incidence of 1.4% (95% CI 0.9-1.8%) for pseudarthrosis in adolescent idiopathic scoliosis, 2.2% (95% CI 1.3-3.2%) in neuromuscular scoliosis, and 6.3% (95% CI 4.3-8.2%) in adult spinal deformity. Risk factors for pseudarthrosis include age over 55, construct length greater than 12 segments, smoking, thoracolumbar kyphosis greater than 20°, and fusion to the sacrum. Choice of graft material, pre-operative coronal alignment, post-operative analgesics, and sex have no significant impact on fusion rates. Older patients with greater deformity requiring more extensive instrumentation are at higher risk for pseudarthrosis. Overall incidence of pseudarthrosis requiring reoperation is low in adult populations and very low in adolescent populations.Item Open Access Pseudarthrosis rate following anterior cervical discectomy with fusion using an allograft cellular bone matrix: a multi-institutional analysis.(Neurosurgical focus, 2021-06) Bergin, Stephen M; Wang, Timothy Y; Park, Christine; Rajkumar, Shashank; Goodwin, C Rory; Karikari, Isaac O; Abd-El-Barr, Muhammad M; Shaffrey, Christopher I; Yarbrough, Chester K; Than, Khoi DObjective
The use of osteobiologics, engineered materials designed to promote bone healing by enhancing bone growth, is becoming increasingly common for spinal fusion procedures, but the efficacy of some of these products is unclear. The authors performed a retrospective, multi-institutional study to investigate the clinical and radiographic characteristics of patients undergoing single-level anterior cervical discectomy with fusion performed using the osteobiologic agent Osteocel, an allograft mesenchymal stem cell matrix.Methods
The medical records across 3 medical centers and 12 spine surgeons were retrospectively queried for patients undergoing single-level anterior cervical discectomy and fusion (ACDF) with the use of Osteocel. Pseudarthrosis was determined based on CT or radiographic imaging of the cervical spine. Patients were determined to have radiographic pseudarthrosis if they met any of the following criteria: 1) lack of bridging bone on CT obtained > 300 days postoperatively, 2) evidence of instrumentation failure, or 3) motion across the index level as seen on flexion-extension cervical spine radiographs. Univariate and multivariate analyses were then performed to identify independent preoperative or perioperative predictors of pseudarthrosis in this population.Results
A total of 326 patients met the inclusion criteria; 43 (13.2%) patients met criteria for pseudarthrosis, of whom 15 (34.9%) underwent revision surgery. There were no significant differences between patients with and those without pseudarthrosis, respectively, for patient age (54.1 vs 53.8 years), sex (34.9% vs 47.4% male), race, prior cervical spine surgery (37.2% vs 33.6%), tobacco abuse (16.3% vs 14.5%), chronic kidney disease (2.3% vs 2.8%), and diabetes (18.6% vs 14.5%) (p > 0.05). Presence of osteopenia or osteoporosis (16.3% vs 3.5%) was associated with pseudarthrosis (p < 0.001). Implant type was also significantly associated with pseudarthrosis, with a 16.4% rate of pseudarthrosis for patients with polyetherethereketone (PEEK) implants versus 8.4% for patients with allograft implants (p = 0.04). Average lengths of follow-up were 27.6 and 23.8 months for patients with and those without pseudarthrosis, respectively. Multivariate analysis demonstrated osteopenia or osteoporosis (OR 4.97, 95% CI 1.51-16.4, p < 0.01) and usage of PEEK implant (OR 2.24, 95% CI 1.04-4.83, p = 0.04) as independent predictors of pseudarthrosis.Conclusions
In patients who underwent single-level ACDF, rates of pseudarthrosis associated with the use of the osteobiologic agent Osteocel are higher than the literature-reported rates associated with the use of alternative osteobiologics. This is especially true when Osteocel is combined with a PEEK implant.Item Open Access Surgical management of high-grade paediatric spondylolisthesis: meta-analysis and systematic review.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2023-02) Koucheki, Robert; Rocos, Brett; Gandhi, Rajiv; Lewis, Stephen J; Lebel, David EPurpose
There is currently no consensus on the management of high-grade spondylolisthesis (HGS) in paediatric populations. The objective of this analysis is to compare the outcomes of reduction followed by fusion (RFF) or in situ fusion (ISF) in paediatric patients.Methods
Using major databases, a systematic literature search was performed. Primary studies comparing ISF with RFF in paediatric and adolescent patients were identified. Study data including patient-reported outcomes, complications, and spinopelvic parameters were collected and analysed.Results
Seven studies were included, comprising 97 ISF and 131 RFF. Average patient age was 14.4 ± 2.1 years and follow up was 8.2 ± 5.1 years. Patients undergoing RFF compared to patients undergoing ISF alone were less likely to develop pseudarthrosis (RR 0.51, 95% CI, [0.26, 0.99], p = 0.05). On average, RFF led to 11.97º more reduction in slip angle and 34.8% more reduction in sagittal translation (p < 0.00001) compared to ISF. There was no significant difference between patient satisfaction and pain at follow up. Neurologic complications and reoperation rates were not significantly different.Conclusions
Both RFF and ISF are effective techniques for managing HGS. Performing a reduction followed by fusion reduces the likelihood of pseudarthrosis in paediatric patients. The difference between risk of neurologic complications, need for reoperation, patient satisfaction, and pain outcomes did not reach statistical significance. Correlation with patient-reported outcomes still needs to be further explored. LEVEL 3 EVIDENCE: Meta-analysis of Level 3 studies.Item Open Access What is the Optimal Surgical Method for Achieving Correction and Avoiding Neurological Complications in Pediatric High-grade Spondylolisthesis?(Journal of pediatric orthopedics, 2021-03) Rocos, Brett; Strantzas, Samuel; Zeller, Reinhard; Lewis, Stephen; Tan, Tony; Lebel, DavidBackground
Controversy persists in the treatment of high-grade spondylolisthesis (HGS). Surgery is recommended in patients with intrusive symptoms and evidence debates the competing strategies. This study compares the radiologic outcomes and postoperative complications at a minimum of 2 years follow-up for patients with HGS treated with instrumented fusion with partial reduction (IFIS) with those treated with reduction, decompression, and instrumented fusion (RIF). We hypothesize that IFIS leads to a lower rate of complication and revision surgery than RIF.Methods
A retrospective comparative methodology was used to analyze consecutive HGS treated surgically between 2006 and 2017. Patients diagnosed with ≥grade 3 spondylolisthesis treated with arthrodesis before the age of 18 years with a minimum of 2 years follow-up were included. Patients were excluded if surgery did not aim to achieve arthrodesis or was a revision procedure. Cases were identified through departmental and neurophysiological records.Results
Thirty patients met the inclusion criteria. Mean follow-up was 4 years. Ten patients underwent IFIS and the remaining 20 underwent RIF. The 2 groups showed no difference in demographics, grade of slip, deformity or presenting symptoms. Of 10 treated with IFIS, the SA reduced by a mean of 10 degrees and C7 sagittal vertical line changed by 31 mm. In the RIF cohort, SA reduced by 16 degrees and C7 sagittal vertical line reduced by 26 mm. PT was unchanged in both groups. In IFIS cohort, 2 patients showed postoperative weakness, resolved by 2 years. None required revision surgery. In the RIF group, 4 sustained dural tears and 1 a laminar fracture, 7 showed postoperative weakness or dysaesthesia, 3 of which had not resolved by 2 years. Eight patients underwent unplanned further surgery, 3 for pseudarthrosis.Conclusions
RIF and IFIS show similar radiologic outcomes. RIF shows a higher rate of unplanned return to surgery, pseudarthrosis and persisting neurological changes.Level of evidence
Level III-retrospective comparative study.