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Cheerag D. Upadhyaya, Jau-Ching Wu, Gregory Trost, Regis W. Haid, Vincent C. Traynelis, Bobby Tay, Domagoj Coric and Praveen V. Mummaneni

Object

There are now 3 randomized, multicenter, US FDA investigational device exemption, industry-sponsored studies comparing arthroplasty with anterior cervical discectomy and fusion (ACDF) for single-level cervical disease with 2 years of follow-up. These 3 studies evaluated the Prestige ST, Bryan, and ProDisc-C artificial discs. The authors analyzed the combined results of these trials.

Methods

A total of 1213 patients with symptomatic, single-level cervical disc disease were randomized into 2 treatment arms in the 3 randomized trials. Six hundred twenty-one patients received an artificial cervical disc, and 592 patients were treated with ACDF. In the three trials, 94% of the arthroplasty group and 87% of the ACDF group have completed 2 years of follow-up. The authors analyzed the 2-year data from these 3 trials including previously unpublished source data. Statistical analysis was performed with fixed and random effects models.

Results

The authors' analysis revealed that segmental sagittal motion was preserved with arthroplasty (preoperatively 7.26° and postoperatively 8.14°) at the 2-year time point. The fusion rate for ACDF at 2 years was 95%. The Neck Disability Index, 36-Item Short Form Health Survey Mental, and Physical Component Summaries, neck pain, and arm pain scores were not statistically different between the groups at the 24-month follow-up. The arthroplasty group demonstrated superior results at 24 months in neurological success (RR 0.595, I2 = 0%, p = 0.006). The arthroplasty group had a lower rate of secondary surgeries at the 2-year time point (RR 0.44, I2 = 0%, p = 0.004). At the 2-year time point, the reoperation rate for adjacent-level disease was lower for the arthroplasty group when the authors analyzed the combined data set using a fixed effects model (RR 0.460, I2 = 2.9%, p = 0.030), but this finding was not significant using a random effects model. Adverse event reporting was too heterogeneous between the 3 trials to combine for analysis.

Conclusions

Both anterior cervical discectomy and fusion as well as arthroplasty demonstrate excellent 2-year surgical results for the treatment of 1-level cervical disc disease with radiculopathy. Arthroplasty is associated with a lower rate of secondary surgery and a higher rate of neurological success at 2 years. Arthroplasty may be associated with a lower rate of adjacent-level disease at 2 years, but further follow-up and analysis are needed to confirm this finding.

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Dominic Amara, Praveen V. Mummaneni, Christopher P. Ames, Bobby Tay, Vedat Deviren, Shane Burch, Sigurd H. Berven and Dean Chou

OBJECTIVE

Many options exist for the surgical management of adult spinal deformity. Radiculopathy and lumbosacral pain from the fractional curve (FC), typically from L4 to S1, is frequently a reason for scoliosis patients to pursue surgical intervention. The purpose of this study was to evaluate the outcomes of limited fusion of the FC only versus treatment of the entire deformity with long fusions.

METHODS

All adult scoliosis patients treated at the authors’ institution in the period from 2006 to 2016 were retrospectively analyzed. Patients with FCs from L4 to S1 > 10° and radiculopathy ipsilateral to the concavity of the FC were eligible for study inclusion and had undergone three categories of surgery: 1) FC only (FC group), 2) lower thoracic to sacrum (LT group), or 3) upper thoracic to sacrum (UT group). Primary outcomes were the rates of revision surgery and complications. Secondary outcomes were estimated blood loss, length of hospital stay, and discharge destination. Spinopelvic parameters were measured, and patients were stratified accordingly.

RESULTS

Of the 99 patients eligible for inclusion in the study, 27 were in the FC group, 46 in the LT group, and 26 in the UT group. There were no significant preoperative differences in age, sex, smoking status, prior operation, FC magnitude, pelvic tilt (PT), sagittal vertical axis (SVA), coronal balance, pelvic incidence–lumbar lordosis (PI-LL) mismatch, or proportion of well-aligned spines (SVA < 5 cm, PI-LL mismatch < 10°, and PT < 20°) among the three treatment groups. Mean follow-up was 30 (range 12–112) months, with a minimum 1-year follow-up. The FC group had a lower medical complication rate (22% [FC] vs 57% [LT] vs 58% [UT], p = 0.009) but a higher rate of extension surgery (26% [FC] vs 13% [LT] vs 4% [UT], p = 0.068). The respective average estimated blood loss (592 vs 1950 vs 2634 ml, p < 0.001), length of hospital stay (5.5 vs 8.3 vs 8.3 days, p < 0.001), and rate of discharge to acute rehabilitation (30% vs 46% vs 85%, p < 0.001) were all lower for FC and highest for UT.

CONCLUSIONS

Treatment of the FC only is associated with a lower complication rate, shorter hospital stay, and less blood loss than complete scoliosis treatment. However, there is a higher associated rate of extension of the construct to the lower or upper thoracic levels, and patients should be counseled when considering their options.

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Yoon Ha, Keishi Maruo, Linda Racine, William W. Schairer, Serena S. Hu, Vedat Deviren, Shane Burch, Bobby Tay, Dean Chou, Praveen V. Mummaneni, Christopher P. Ames and Sigurd H. Berven

Object

Proximal junctional kyphosis (PJK) is a common and significant complication after corrective spinal deformity surgery. The object of this study was to compare—based on clinical outcomes, postoperative proximal junctional kyphosis rates, and prevalence of revision surgery—proximal thoracic (PT) and distal thoracic (DT) upper instrumented vertebra (UIV) in adults who underwent spine fusion to the sacrum for the treatment of spinal deformity.

Methods

In this retrospective study the authors evaluated clinical and radiographic data from consecutive adults (age > 21 years) with a deformity treated using long instrumented posterior spinal fusion to the sacrum in the period from 2007 to 2009. The PT group included patients in whom the UIV was between T-2 and T-5, whereas the DT group included patients in whom the UIV level was between T-9 and L-1. Perioperative surgical data were compared between the PT and DT groups. Additionally, segmental, regional, and global spinal alignments, as well as the sagittal Cobb angle at the proximal junction, were analyzed on preoperative, early postoperative, and final standing 36-in. radiographs. Patient-reported outcome measurements (visual analog scale, Scoliosis Research Society Patient Questionnaire-22, Oswestry Disability Index, and the 36-Item Short-Form Health Survey) were compared.

Results

Eighty-nine patients, 22 males and 67 females, had a minimum follow-up of 2 years, and thus were eligible for participation in this study. Sixty-seven patients were in the DT group and 22 were in the PT group. Operative time (p = 0.387) and estimated blood loss (p < 0.05) were slightly higher in the PT group. The overall rate of revision surgery was 48.0% and 54.5% in the DT and PT groups, respectively (p = 0.629). The prevalence of PJK according to radiological criteria was 34% in the DT group and 27% in the PT group (p = 0.609). The percent of patients with PJK that required surgical correction (surgical PJK) was 11.9% (8 of 67) in the DT group and 9.1% (2 of 22) in the PT group (p = 1.0). The onset of surgical PJK was significantly earlier than radiological PJK in the DT group (p < 0.01). The types of PJK were different in the PT and DT groups. Compression fracture at the UIV was more prevalent in the DT group, whereas subluxation was more prevalent in the PT group. Postoperatively, the PT group had less thoracic kyphosis (p = 0.02), less sagittal imbalance (p < 0.01), and less pelvic tilt (p = 0.04). In the DT group, early postoperative radiographs demonstrated that the proximal junctional angle of patients with surgical PJK was greater than in those without PJK and those with radiological PJK (p < 0.01). Clinical outcomes were significantly improved in both groups, and there was no significant difference between the groups.

Conclusions

Both PT and DT UIVs improve segmental and global sagittal plane alignment as well as patient-reported quality of life in those treated for adult spinal deformity. The prevalence of PJK was not different in the PT and DT groups. However, compression fracture was the mechanism more frequently observed with DT PJK, and subluxation was the mechanism more frequently observed in PT PJK. Strategies to avoid PJK may include vertebral augmentation to prevent fracture at the DT spine and mechanical means to prevent vertebral subluxation at the PT spine.

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Michael G. Fehlings and Aria Fallah

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Takahito Fujimori, Shinichi Inoue, Hai Le, William W. Schairer, Sigurd H. Berven, Bobby K. Tay, Vedat Deviren, Shane Burch, Motoki Iwasaki and Serena S. Hu

Object

Despite increasing numbers of patients with adult spinal deformity, it is unclear how to select the optimal upper instrumented vertebra (UIV) in long fusion surgery for these patients. The purpose of this study was to compare the use of vertebrae in the upper thoracic (UT) versus lower thoracic (LT) spine as the upper instrumented vertebra in long fusion surgery for adult spinal deformity.

Methods

Patients who underwent fusion from the sacrum to the thoracic spine for adult spinal deformity with sagittal imbalance at a single medical center were studied. The patients with a sagittal vertical axis (SVA) ≥ 40 mm who had radiographs and completed the 12-item Short-Form Health Survey (SF-12) preoperatively and at final follow-up (≥ 2 years postoperatively) were included.

Results

Eighty patients (mean age of 61.1 ± 10.9 years; 69 women and 11 men) met the inclusion criteria. There were 31 patients in the UT group and 49 patients in the LT group. The mean follow-up period was 3.6 ± 1.6 years. The physical component summary (PCS) score of the SF-12 significantly improved from the preoperative assessment to final follow-up in each group (UT, 34 to 41; LT, 29 to 37; p = 0.001). This improvement reached the minimum clinically important difference in both groups. There was no significant difference in PCS score improvement between the 2 groups (p = 0.8). The UT group had significantly greater preoperative lumbar lordosis (28° vs 18°, p = 0.03) and greater thoracic kyphosis (36° vs 18°, p = 0.001). After surgery, there was no significant difference in lumbar lordosis or thoracic kyphosis. The UT group had significantly greater postoperative cervicothoracic kyphosis (20° vs 11°, p = 0.009). The UT group tended to maintain a smaller positive SVA (51 vs 73 mm, p = 0.08) and smaller T-1 spinopelvic inclination (−2.6° vs 0.6°, p = 0.06). The LT group tended to have more proximal junctional kyphosis (PJK), although the difference did not reach statistical significance. Radiographic PJK was 32% in the UT group and 41% in the LT group (p = 0.4). Surgical PJK was 6.4% in the UT group and 10% in the LT group (p = 0.6).

Conclusions

Both the UT and LT groups demonstrated significant improvement in clinical and radiographic outcomes. A significant difference was not observed in improvement of clinical outcomes between the 2 groups.

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Junseok Bae, Alexander A. Theologis, Russell Strom, Bobby Tay, Shane Burch, Sigurd Berven, Praveen V. Mummaneni, Dean Chou, Christopher P. Ames and Vedat Deviren

OBJECTIVE

Surgical treatment of adult spinal deformity (ASD) is an effective endeavor that can be accomplished using a variety of surgical strategies. Here, the authors assess and compare radiographic data, complications, and health-related quality-of-life (HRQoL) outcome scores among patients with ASD who underwent a posterior spinal fixation (PSF)–only approach, a posterior approach combined with lateral lumbar interbody fusion (LLIF+PSF), or a posterior approach combined with anterior lumbar interbody fusion (ALIF+PSF).

METHODS

The medical records of consecutive adults who underwent thoracolumbar fusion for ASD between 2003 and 2013 at a single institution were reviewed. Included were patients who underwent instrumentation from the pelvis to L-1 or above, had a sagittal vertical axis (SVA) of < 10 cm, and underwent a minimum of 2 years’ follow-up. Those who underwent a 3-column osteotomy were excluded. Three groups of patients were compared on the basis of the procedure performed, LLIF+PSF, ALIF+PSF, and PSF only. Perioperative spinal deformity parameters, complications, and HRQoL outcome scores (Oswestry Disability Index [ODI], Scoliosis Research Society 22-question Questionnaire [SRS-22], 36-Item Short Form Health Survey [SF-36], visual analog scale [VAS] for back/leg pain) from each group were assessed and compared with each other using ANOVA. The minimal clinically important differences used were −1.2 (VAS back pain), −1.6 (VAS leg pain), −15 (ODI), 0.587/0.375/0.8/0.42 (SRS-22 pain/function/self-image/mental health), and 5.2 (SF-36, physical component summary).

RESULTS

A total of 221 patients (58 LLIF, 91 ALIF, 72 PSF only) met the inclusion criteria. Average deformities consisted of a SVA of < 10 cm, a pelvic incidence–lumbar lordosis (LL) mismatch of > 10°, a pelvic tilt of > 20°, a lumbar Cobb angle of > 20°, and a thoracic Cobb angle of > 15°. Preoperative SVA, LL, pelvic incidence–LL mismatch, and lumbar and thoracic Cobb angles were similar among the groups. Patients in the PSF-only group had more comorbidities, those in the ALIF+PSF group were, on average, younger and had a lower body mass index than those in the LLIF+PSF group, and patients in the LLIF+PSF group had a significantly higher mean number of interbody fusion levels than those in the ALIF+PSF and PSF-only groups. At final follow-up, all radiographic parameters and the mean numbers of complications were similar among the groups. Patients in the LLIF+PSF group had proximal junctional kyphosis that required revision surgery significantly less often and fewer proximal junctional fractures and vertebral slips. All preoperative HRQoL scores were similar among the groups. After surgery, the LLIF+PSF group had a significantly lower ODI score, higher SRS-22 self-image/total scores, and greater achievement of the minimal clinically important difference for the SRS-22 pain score.

CONCLUSIONS

Satisfactory radiographic outcomes can be achieved similarly and adequately with these 3 surgical approaches for patients with ASD with mild to moderate sagittal deformity. Compared with patients treated with an ALIF+PSF or PSF-only surgical strategy, patients who underwent LLIF+PSF had lower rates of proximal junctional kyphosis and mechanical failure at the upper instrumented vertebra and less back pain, less disability, and better SRS-22 scores.

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Michael M. Safaee, Alexander Tenorio, Joseph A. Osorio, Winward Choy, Dominic Amara, Lillian Lai, Annette M. Molinaro, Yalan Zhang, Serena S. Hu, Bobby Tay, Shane Burch, Sigurd H. Berven, Vedat Deviren, Sanjay S. Dhall, Dean Chou, Praveen V. Mummaneni, Charles M. Eichler, Christopher P. Ames and Aaron J. Clark

OBJECTIVE

Anterior approaches to the lumbar spine provide wide exposure that facilitates placement of large grafts with high fusion rates. There are limited data on the effects of obesity on perioperative complications.

METHODS

Data from consecutive patients undergoing anterior lumbar interbody fusion (ALIF) from 2007 to 2016 at a single academic center were analyzed. The primary outcome was any perioperative complication. Complications were divided into those occurring intraoperatively and those occurring postoperatively. Multivariate logistic regression was used to assess the association of obesity and other variables with these complications. An estimation table was used to identify a body mass index (BMI) threshold associated with increased risk of postoperative complication.

RESULTS

A total of 938 patients were identified, and the mean age was 57 years; 511 were females (54.5%). The mean BMI was 28.7 kg/m2, with 354 (37.7%) patients classified as obese (BMI ≥ 30 kg/m2). Forty patients (4.3%) underwent a lateral transthoracic approach, while the remaining 898 (95.7%) underwent a transabdominal retroperitoneal approach. Among patients undergoing transabdominal retroperitoneal ALIF, complication rates were higher for obese patients than for nonobese patients (37.0% vs 28.7%, p = 0.010), a difference that was driven primarily by postoperative complications (36.1% vs 26.0%, p = 0.001) rather than intraoperative complications (3.2% vs 4.3%, p = 0.416). Obese patients had higher rates of ileus (11.7% vs 7.2%, p = 0.020), wound complications (11.4% vs 3.4%, p < 0.001), and urinary tract infections (UTI) (5.0% vs 2.5%, p = 0.049). In a multivariate model, age, obesity, and number of ALIF levels fused were associated with an increased risk of postoperative complication. An estimation table including 19 candidate cut-points, odds ratios, and adjusted p values found a BMI ≥ 31 kg/m2 to have the highest association with postoperative complication (p = 0.012).

CONCLUSIONS

Obesity is associated with increased postoperative complications in ALIF, including ileus, wound complications, and UTI. ALIF is a safe and effective procedure. However, patients with a BMI ≥ 31 kg/m2 should be counseled on their increased risks and warrant careful preoperative medical optimization and close monitoring in the postoperative setting.