BACKGROUND: Literature supports the need for improved techniques to achieve spinopelvic alignment and reduce complication rates in patients with adult spinal deformity (ASD). Personalized interbody devices were developed to address this need and are under evaluation in the multicenter Clinical Outcome Measures in Personalized aprevo (circle R superscript) Spine Surgery (COMPASS (TM suprascript) registry. This report presents interim COMPASS pre- and postoperative sagittal alignment results and complication rates for a subcohort of COMPASS patients diagnosed and surgically treated for spinal deformity. METHODS: COMPASS is a postmarket observational registry of patients enrolled either before or after index surgery and then followed prospectively for 24 months. Sagittal alignment was assessed with SRS-Schwab modifiers for pelvic incidence minus lumbar lordosis, pelvic tilt, and T1 pelvic angle. Summed SRS-Schwab modifiers were utilized to assign overall deformity status as mild, moderate, or severe. Complications were extracted from patient medical records. RESULTS: The study included 67 patients from 9 centers. Preoperative severe deformity was observed in 66% of patients. Index surgeries included implantation of a median of 2 personalized interbody devices by anterior, lateral, or transforaminal approaches and with a median of 8 posteriorly instrumented levels. Overall postoperative sagittal alignment improved with a significant decrease in the mean sum of SRS-Schwab modifiers that correlated strongly to improvements in pelvic incidence minus lumbar lordosis. Among 44 patients with preoperative severe overall deformity, 16 improved to moderate and 9 to mild deformity. Complications occurred for 13 patients (19.4%), including 1 mechanical complication requiring revision 9 months after surgery and none related to personalized interbody devices. CONCLUSIONS: This study demonstrates that ASD patients whose treatment included personalized interbody devices can obtain favorable postoperative alignment status comparable to published results and with no complications related to the personalized interbody devices. CLINICAL RELEVANCE: This study contributes to growing evidence that personalized interbody devices contribute to improved sagittal alignment in ASD patients by directly adjusting the orientation of adjacent vertebra.

BACKGROUND: Lumbar lordosis distribution has become a pivotal factor in re-establishing the foundational alignment of the lumbar spine. This can directly influence overall sagittal alignment, leading to improved long-term outcomes for patients. Despite the wide availability of hyperlordotic stock cages intended to achieve optimal postoperative alignment, there is a lack of correlation between the lordotic shape of a cage and the resultant intervertebral alignment. Recently, personalized spine surgery has witnessed significant advancements, including 3D-printed personalized interbody implants, which are customized to the surgeons treatment and alignment goals. This study evaluates the reliability of 3D-printed patient-specific interbody implants to achieve the planned postoperative intervertebral alignment. METHODS: This is a retrospective study of 217 patients with spinal deformity or degenerative conditions. Patients were included if they received 3D-printed personalized interbody implants. The desired intervertebral lordosis (IVL) angle was prescribed into the device design for each personalized interbody (IVL goal). Standing postoperative radiographs were measured, and the IVL offset was calculated as IVL achieved minus IVL goal. RESULTS: In this patient population, 365 personalized interbodies were implanted, including 145 anterior lumbar interbody fusions (ALIFs), 99 lateral lumbar interbody fusions (LLIFs), and 121 transforaminal lumbar interbody fusions. Among the 365 treated levels, IVL offset was 1.1° ± 4.4° (mean ± SD). IVL was achieved within 5° of the plan in 299 levels (81.9%). IVL offset depended on the approach of the lumbar interbody fusion and was achieved within 5° for 85.9% of LLIF, 82.6% of transforaminal lumbar interbody fusions and 78.6% of ALIFs. Ten levels (2.7%) missed the planned IVL by >10°. ALIF and LLIF levels in which the plan was missed by more than 5° tended to be overcorrected. CONCLUSIONS: This study supports the use of 3D-printed personalized interbody implants to achieve planned sagittal intervertebral alignment. CLINICAL RELEVANCE: Personalized interbody implants can consistently achieve IVL goals and potentially impact foundational lumbar alignment.

Objective

Previous reports of rod fracture (RF) in adult spinal deformity are limited by heterogeneous cohorts, low follow-up rates, and relatively short follow-up durations. Since the majority of RFs present > 2 years after surgery, true occurrence and revision rates remain unclear. The objectives of this study were to better understand the risk factors for RF and assess its occurrence and revision rates following primary thoracolumbar fusions to the sacrum/pelvis for adult symptomatic lumbar scoliosis (ASLS) in a prospective series with long-term follow-up.

Methods

Patient records were obtained from the Adult Symptomatic Lumbar Scoliosis-1 (ASLS-1) database, an NIH-sponsored multicenter, prospective study. Inclusion criteria were as follows: patients aged 40-80 years undergoing primary surgeries for ASLS (Cobb angle ≥ 30° and Oswestry Disability Index ≥ 20 or Scoliosis Research Society-22r ≤ 4.0 in pain, function, and/or self-image) with instrumented fusion of ≥ 7 levels that included the sacrum/pelvis. Patients with and without RF were compared to assess risk factors for RF and revision surgery.

Results

Inclusion criteria were met by 160 patients (median age 62 years, IQR 55.7-67.9 years). At a median follow-up of 5.1 years (IQR 3.8-6.6 years), there were 92 RFs in 62 patients (38.8%). The median time to RF was 3.0 years (IQR 1.9-4.54 years), and 73% occurred > 2 years following surgery. Based on Kaplan-Meier analyses, estimated RF rates at 2, 4, 5, and 8 years after surgery were 11%, 24%, 35%, and 49%, respectively. Baseline radiographic, clinical, and demographic characteristics were similar between patients with and without RF. In Cox regression models, greater postoperative pelvic tilt (HR 1.895, 95% CI 1.196-3.002, p = 0.0065) and greater estimated blood loss (HR 1.02, 95% CI 1.005-1.036, p = 0.0088) were associated with increased risk of RF. Thirty-eight patients (61% of all RFs) underwent revision surgery. Bilateral RF was predictive of revision surgery (HR 3.52, 95% CI 1.8-6.9, p = 0.0002), while patients with unilateral nondisplaced RFs were less likely to require revision (HR 0.39, 95% CI 0.18-0.84, p = 0.016).

Conclusions

This study provides what is to the authors' knowledge the highest-quality data to date on RF rates following ASLS surgery. At a median follow-up of 5.1 years, 38.8% of patients had at least one RF. Estimated RF rates at 2, 4, 5, and 8 years after surgery were 11%, 24%, 35%, and 49%, respectively. Greater estimated blood loss and postoperative pelvic tilt were significant risk factors for RF. These findings emphasize the importance of long-term follow-up to realize the true prevalence and cumulative incidence of RF.

Objective

Proximal junctional failure (PJF) is a severe form of proximal junctional kyphosis. Previous reports on PJF have been limited by heterogeneous cohorts and relatively short follow-ups. The authors' objectives herein were to identify risk factors for PJF and to assess its long-term incidence and revision rates in a homogeneous cohort.

Methods

The authors reviewed data from the Adult Symptomatic Lumbar Scoliosis 1 trial (ASLS-1), a National Institutes of Health-sponsored prospective multicenter study. Inclusion criteria were an age ≥ 40 years, ASLS (Cobb angle ≥ 30° and Oswestry Disability Index [ODI] ≥ 20 or Scoliosis Research Society revised 22-item questionnaire [SRS-22r] score ≤ 4.0 in pain, function, or self-image domains), and primary thoracolumbar fusion/fixation to the sacrum/pelvis of ≥ 7 levels. PJF was defined as a postoperative proximal junctional angle (PJA) change > 20°, fracture of the uppermost instrumented vertebra (UIV) or UIV+1 with > 20% vertebral height loss, spondylolisthesis of UIV/UIV+1 > 3 mm, or UIV screw dislodgment.

Results

One hundred sixty patients (141 women) were included in this analysis and had a median age of 62 years and a mean follow-up of 4.3 years (range 0.1-6.1 years). Forty-six patients (28.8%) had PJF at a median of 0.92 years (IQR 0.14, 1.23 years) following surgery. Based on Kaplan-Meier analyses, PJF rates at 1, 2, 3, and 4 years were 14.4%, 21.9%, 25.9%, and 27.4%, respectively. On univariate analysis, PJF was associated with greater age (p = 0.0316), greater body mass index (BMI; p = 0.0319), worse baseline patient-reported outcome measures (PROMs; ODI, SRS-22r, and SF-12 Physical Component Summary [PCS]; all p < 0.04), the use of posterior column osteotomies (PCOs; p = 0.0039), and greater postoperative thoracic kyphosis (TK; p = 0.0031) and PJA (p < 0.001). The use of UIV hooks was protective against PJF (p = 0.0340). On regression analysis (without postoperative measures), PJF was associated with greater BMI (HR 1.077, 95% CI 1.007-1.153, p = 0.0317), lower preoperative PJA (HR 0.607, 95% CI 0.407-0.906, p = 0.0146), and greater preoperative TK (HR 1.362, 95% CI 1.082-1.715, p = 0.0085). Patients with PJF had worse PROMs at the last follow-up (ODI, SRS-22r subscore and self-image, and SF-12 PCS; p < 0.04). Sixteen PJF patients (34.8%) underwent revision, and PJF recurred in 3 (18.8%).

Conclusions

Among 160 primary ASLS patients with a median age of 62 years and predominant coronal deformity, the PJF rate was 28.8% at a mean 4.3-year follow-up, with a revision rate of 34.8%. On univariate analysis, PJF was associated with a greater age and BMI, worse baseline PROMs, the use of PCOs, and greater postoperative TK and PJA. The use of UIV hooks was protective against PJF. On multivariate analysis (without postoperative measures), a higher risk of PJF was associated with greater BMI and preoperative TK and lower preoperative PJA.