Lumbar Facet Arthroplasty Versus Fusion for Grade-I Degenerative Spondylolisthesis with Stenosis: A Prospective Randomized Controlled Trial.

BACKGROUND: The comparative effectiveness of decompression plus lumbar facet arthroplasty versus decompression plus instrumented lumbar spinal fusion in patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis is unknown. METHODS: In this randomized, controlled, Food and Drug Administration Investigational Device Exemption trial, we assigned patients who had single-level lumbar spinal stenosis and grade-I degenerative spondylolisthesis to undergo decompression plus lumbar facet arthroplasty (arthroplasty group) or decompression plus fusion (fusion group). The primary outcome was a predetermined composite clinical success score. Secondary outcomes included the Oswestry Disability Index (ODI), visual analog scale (VAS) back and leg pain, Zurich Claudication Questionnaire (ZCQ), Short Form (SF)-12, radiographic parameters, surgical variables, and complications. RESULTS: A total of 321 adult patients were randomized in a 2:1 fashion, with 219 patients assigned to undergo facet arthroplasty and 102 patients assigned to undergo fusion. Of these, 113 patients (51.6%) in the arthroplasty group and 47 (46.1%) in the fusion group who had either reached 24 months of postoperative follow-up or were deemed early clinical failures were included in the primary outcome analysis. The arthroplasty group had a higher proportion of patients who achieved composite clinical success than did the fusion group (73.5% versus 25.5%; p < 0.001), equating to a between-group difference of 47.9% (95% confidence interval, 33.0% to 62.8%). The arthroplasty group outperformed the fusion group in most patient-reported outcome measures (including the ODI, VAS back pain, and all ZCQ component scores) at 24 months postoperatively. There were no significant differences between groups in surgical variables or complications, except that the fusion group had a higher rate of developing symptomatic adjacent segment degeneration. CONCLUSIONS: Among patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis, lumbar facet arthroplasty was associated with a higher rate of composite clinical success than fusion was at 24 months postoperatively. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Evolution of the Transforaminal Lumbar Interbody Fusion (TLIF): From Open to Percutaneous to Patient-Specific.

The transforaminal lumbar interbody fusion (TLIF) has seen significant evolution since its early inception, reflecting advancements in surgical techniques, patient safety, and outcomes. Originally described as an improvement over the posterior lumbar interbody fusion (PLIF), the TLIF began as an open surgical procedure, that notably reduced the need for the extensive neural retractation that hindered the PLIF. In line with the broader practice of surgery, trending toward minimally invasive access, the TLIF was followed by the development of the minimally invasive TLIF (MIS-TLIF), a technique that further decreased tissue trauma and postoperative complications. Subsequent advancements, including Trans-Kambin's Triangle TLIF (percLIF) and transfacet LIF, have continued to refine surgical access, minimize surgical footprint, and reduce the risk of injury to the patient. The latest evolution, as we will describe it, the patient-specific TLIF, is a culmination of the aforementioned adaptations and incorporates advanced imaging and segmentation technologies into perioperative planning, allowing surgeons to tailor approaches based on individual patient anatomy and pathology. These developments signify a shift towards more precise methods in spine surgery. The ongoing evolution of the TLIF technique illustrates the dynamic nature of surgery and emphasizes the need for continued adaptation and refinement.

Catheter Tip-Associated Mass With Continuous Infusion of Sufentanil for Persistent Spinal Pain Syndrome Type 2: A Case Report Including Histopathologic Examination and Review of the Associated Basic and Clinical Research.

OBJECTIVES: Intrathecal opioids delivered by implanted pumps are used to treat malignant or nonmalignant chronic pain. In this study, we 1) review a case in which intrathecal infusions of sufentanil along with other adjuvants were used and after an extended period led to an intrathecal mass and 2) compared and contrasted the potential mechanisms for these phenomena. MATERIALS AND METHODS: A woman aged 66 years with a history of scoliosis and multiple spine surgeries was treated with an implantable drug delivery system for treating persistent pain after laminectomy. The patient received intrathecal medication comprising sufentanil, bupivacaine, and clonidine. RESULTS: Intrathecal therapy over approximately ten years served to reduce pain and improve function over the treatment period. After the extended treatment interval, the patient developed an intrathecal mass that was associated with impairment. The mass was surgically removed. Systematic histopathology revealed the space-occupying mass to largely comprise fibroblasts and some inflammatory cells embedded in a collagen mass located proximally to the catheter tip. CONCLUSIONS: To our knowledge, this is the first published case report of sufentanil causing this complication. The science and mechanism of intrathecal catheter tip-associated mass formation and associated clinical research correlates are reviewed in detail, and explanations for this phenomenon are proposed based on histochemical analysis of the patient's pathology findings.

Using Novel Segmentation Technology to Define Safe Corridors for Minimally Invasive Posterior Lumbar Interbody Fusion.

BACKGROUND AND OBJECTIVES: There has been a rise in minimally invasive methods to access the intervertebral disk space posteriorly given their decreased tissue destruction, lower blood loss, and earlier return to work. Two such options include the percutaneous lumbar interbody fusion through the Kambin triangle and the endoscopic transfacet approach. However, without accurate preoperative visualization, these approaches carry risks of damaging surrounding structures, especially the nerve roots. Using novel segmentation technology, our goal was to analyze the anatomic borders and relative sizes of the safe triangle, trans-Kambin, and the transfacet corridors to assist surgeons in planning a safe approach and determining cannula diameters. METHODS: The areas of the safe triangle, Kambin, and transfacet corridors were measured using commercially available software (BrainLab, Munich, Germany). For each approach, the exiting nerve root, traversing nerve roots, theca, disk, and vertebrae were manually segmented on 3-dimensional T2-SPACE magnetic resonance imaging using a region-growing algorithm. The triangles' borders were delineated ensuring no overlap between the area and the nerves. RESULTS: A total of 11 patients (65.4 ± 12.5 years, 33.3% female) were retrospectively reviewed. The Kambin, safe, and transfacet corridors were measured bilaterally at the operative level. The mean area (124.1 ± 19.7 mm2 vs 83.0 ± 11.7 mm2 vs 49.5 ± 11.4 mm2) and maximum permissible cannula diameter (9.9 ± 0.7 mm vs 6.8 ± 0.5 mm vs 6.05 ± 0.7 mm) for the transfacet triangles were significantly larger than Kambin and the traditional safe triangles, respectively (P < .001). CONCLUSION: We identified, in 3-dimensional, the borders for the transfacet corridor: the traversing nerve root extending inferiorly until the caudal pedicle, the theca medially, and the exiting nerve root superiorly. These results illustrate the utility of preoperatively segmenting anatomic landmarks, specifically the nerve roots, to help guide decision-making when selecting the optimal operative approach.

Geriatric Surgery Produces a Hypoactive Molecular Phenotype in the Monocyte Immune Gene Transcriptome.

Surgery is a major challenge for the immune system, but little is known about the immune response of geriatric patients to surgery. We therefore investigated the impact of surgery on the molecular signature of circulating CD14+ monocytes, cells implicated in clinical recovery from surgery, in older patients. We enrolled older patients having elective joint replacement (N = 19) or spine (N = 16) surgery and investigated pre- to postoperative expression changes in 784 immune-related genes in monocytes. Joint replacement altered the expression of 489 genes (adjusted p < 0.05), of which 38 had a |logFC| > 1. Spine surgery changed the expression of 209 genes (adjusted p < 0.05), of which 27 had a |logFC| > 1. In both, the majority of genes with a |logFC| > 1 change were downregulated. In the combined group (N = 35), 471 transcripts were differentially expressed (adjusted p < 0.05) after surgery; 29 had a |logFC| > 1 and 72% of these were downregulated. Notably, 21 transcripts were common across procedures. Thus, elective surgery in older patients produces myriad changes in the immune gene transcriptome of monocytes, with many suggesting development of an immunocompromised/hypoactive phenotype. Because monocytes are strongly implicated in the quality of surgical recovery, this signature provides insight into the cellular and molecular mechanisms of the immune response to surgery and warrants further study as a potential biomarker for predicting poor outcomes in older surgical patients.

Shared Decision-Making in Patients Seeking Surgery for Facial Trauma: The Role of Decisional Conflict and Perceived Discrimination.

Background: Shared decision-making (SDM) may facilitate challenging discussions between patients with facial trauma and reconstructive surgeons. Objective: To determine among patients seeking surgical evaluation for facial trauma, whether patient demographics, decisional conflict (DC), or experiences of discrimination in health care are associated with patient perceptions of SDM, as measured by scored responses on the CollaboRATE-10 questionnaire. Methods: English-speaking adults who presented to the offices of five facial trauma surgeons were contacted by telephone after their visit to complete a cross-sectional survey. Results: After screening 247 patients, 131 patients were recruited (53.0%). DC and history of discrimination were associated with lower perceived SDM (p < 0.001 and p = 0.048, respectively). After adjusting for age, sex, race, education, initial emergency department presentation, DC, and past discrimination, patients of older age (odds ratio [OR] 1.1, 95% confidence interval [CI] 1.02-1.09) and non-White race (OR 3.5, 95% CI 1.1-11.4) had higher perceptions of SDM; patients with DC (OR 0.52, 95% CI 0.01-0.20) reported less SDM. Conclusions: Patients who present to clinic for surgical evaluation after facial trauma feel that their physicians involve them less when deciding on a treatment plan if they have experienced discrimination in health care settings in the past, or if they have significant difficulty deciding between treatment options.

Genomic analysis of spinal meningiomas: correlation with histopathological grade.

OBJECTIVE: Spinal meningiomas are one of the most common primary intradural tumors of the adult spine. Spinal meningiomas typically have a benign course with low rates of recurrence. Recent advances in genomic profiling have provided valuable information on meningioma biology and natural history, but these studies have focused primarily on cranial meningiomas. Chromosomal copy number analysis of meningiomas has been shown to be a valuable molecular profiling technique for distinguishing benign from aggressive tumors. The Integrated Grade for Meningioma is a novel grading scheme that uses mitotic index and copy-number profile to identify aggressive tumors at high risk for recurrence. The integrated grade has been shown to be a better predictor of tumor behavior than WHO grade alone. The objective of this study was to evaluate the chromosomal copy-number profile of spinal meningiomas, and to correlate these findings with the assigned WHO grades. METHODS: The authors evaluated 94 spinal meningiomas treated surgically at their institution between 2002 and 2022. The histopathological results including WHO grade, mitotic index, presence of atypical features, and MIB-1 index were recorded. Chromosomal copy number as determined by institutional whole-genome DNA copy-number profiling was available for 57 tumors. RESULTS: The WHO grades of the cohort consisted of 81 (86%) WHO grade 1 tumors and 13 (14%) WHO grade 2 tumors. In tumors for which copy-number profiling was available, 44 (77%) of 57 demonstrated loss of 22q/NF2. Notably absent were frequent high-risk copy number alterations including loss of 1p, 3p, 4p/q, 6p/q, 10p/q, 14q, 18p/q, 19p/q, and focal loss of CDKN2A on 9p. Of the 9 WHO grade 2 tumors for which copy-number profiling was available, 6 tumors were reclassified to a lower risk profile (integrated grade 1). CONCLUSIONS: This analysis suggests that spinal meningiomas exhibit overwhelmingly indolent biology, as supported by their benign integrated grade. These findings have implications in the surgical management of these patients in relation to the need for complete Simpson grade I resection, as well as the potential avoidance of adjuvant therapy following surgery in the setting of otherwise frequently benign pathology.

Two-Year Clinical and Radiographic Outcomes for Percutaneous Lumbar Interbody Fusion With an Expandable Titanium Cage Through Kambin's Triangle Without Facetectomy.

BACKGROUND: There has been heightened interest in performing percutaneous lumbar interbody fusions (percLIFs) through Kambin's triangle, an anatomic corridor allowing entrance into the disc space. However, due to its novelty, there are limited data regarding the long-term benefits of this procedure. Our objective was to determine the long-term efficacy and durability of the percutaneous insertion of an expandable titanium cage through Kambin's triangle without facetectomy. METHODS: A retrospective review of patients undergoing percLIF via Kambin's triangle using an expandable titanium cage was performed. Demographics, visual analog scale (VAS) scores, Oswestry Disability Index (ODI), radiographic measurements, perioperative variables, and complications were recorded. VAS, ODI, and radiographic measurements were compared with baseline using the generalized estimating equations assuming normally distributed data. Fusion was assessed with computed tomography (CT) at 1 and 2 years after the procedure. RESULTS: A total of 49 patients were included. Spondylolisthesis, lumbar lordosis (LL), sacral slope, pelvic tilt, and anterior/posterior disc space height were all significantly improved postoperatively at each time point of 3, 6, 12, and 24 months (P < 0.001). Pelvic incidence-LL mismatch decreased significantly at each follow-up (P < 0.001) with a mean reduction of 4° by 24 months. VAS back scores reduced by >2 points at the 6, 12, and 24 month follow-ups. ODI scores reduced by >15 points at the 12- and 24-month follow-ups. Of the patients who had 1- and 2-year CT images, fusion rates at those time points were 94.4% (17/18) and 87.5% (7/8), respectively. The mean annual rate of surgically significant adjacent segment disease was 2.74% through an average follow-up of 2.74 years. CONCLUSION: These results highlight that percLIF, a procedure done without an endoscope or facetectomy, can be performed using an expandable titanium cage through Kambin's triangle with excellent radiographic and clinical results. CLINICAL RELEVANCE: percLIF via Kambin's triangle is a safe and succesful procedure with long-term improvements in both clinical and radiographic outcomes.

Patient-Reported Outcomes Measures in Rhinoplasty: Need for Use and Implementation.

Patient-reported outcome metrics (PROMs) are increasingly utilized to capture data about patients' quality of life. PROMs play an important role in the value-based health care movement by providing a patient-centered metric of quality. There are many barriers to the implementation of PROMs, and widespread adoption requires buy-in from numerous stakeholders including patients, clinicians, institutions, and payers. Several validated PROMs have been utilized by facial plastic surgeons to measure both functional and aesthetic outcomes among rhinoplasty patients. These PROMs can help clinicians and rhinoplasty patients participate in shared decision making (SDM), a process via which clinicians and patients arrive at treatment decisions together through a patient-centered approach. However, widespread adoption of PROMs and SDM has not yet been achieved. Further work should focus on overcoming barriers to implementation and engaging key stakeholders to increase the utilization of PROMs in rhinoplasty.

Novel Approach to Percutaneous Lumbar Surgeries via Kambin's Triangle-Radiographic and Surgical Planning Analysis with Nerve Segmentation Technology.

OBJECTIVE: While Kambin's Triangle has become an ever more important anatomic window given its proximity to the exiting nerve root, there have been limited studies examining the effect of disease on the corridor. Our goal was to better understand how pathology can affect Kambin's Triangle, thereby altering the laterality of approach for percutaneous lumbar interbody fusion (percLIF). METHODS: The authors performed a single-center retrospective review of patients evaluated for percLIF. The areas of Kambin's Triangle were measured without and with nerve segmentation. For the latter, the lumbosacral nerve roots on 3-dimensional T2 magnetic resonance imaging were manually segmented. Next, the borders of Kambin's Triangle were delineated, ensuring no overlap between the area and nerve above. RESULTS: Fifteen patients (67.5 ± 9.7 years, 46.7% female) were retrospectively reviewed. We measured 150 Kambin's Triangles. The mean areas from L1-S1 were 50.0 ± 12.3 mm2, 73.8 ± 12.5 mm2, 83.8 ± 12.2 mm2, 88.5 ± 19.0 mm2, and 116 ± 29.3 mm2, respectively. When pathology was present, the areas significantly decreased at L4-L5 (P = 0.046) and L5-S1 (P = 0.049). Higher spondylolisthesis and smaller posterior disk heights were linked with decreased areas via linear regression analysis (P < 0.05). When nerve segmentation was used, the areas were significantly smaller from L1-L5 (P < 0.05). Among 11 patients who underwent surgery, none suffered from postoperative neuropathies. CONCLUSIONS: These results illustrate the feasibility of preoperatively segmenting lumbosacral nerves and measuring Kambin's Triangle to help guide surgical planning and determine the ideal laterality of approach for percLIF.

Mastering Midface Injections.

Injectable filler is one of the most common cosmetic procedures performed annually. An aging face shows a characteristic loss of volume in the deep fat pads of the midface. The goal of midfacial rejuvenation with injectable filler is to restore lost volume, with the suborbicularis fat pad and deep medial cheek fat being the most critical areas. Filler can be instilled here with a cannula or needle with successful outcomes. However, this procedure is not without complications if proper technique and underlying anatomy are not respected.

Facial Trauma Operative Volume Demonstrates Consistent and Significant Yearly Periodicity.

PURPOSE: Facial trauma requiring operative care increases during the summer and fall months, which is colloquially referred to as trauma season. The purpose of this study is to determine if there is a quantifiable and statistically significant yearly periodicity of operative facial trauma volume. MATERIALS AND METHODS: To confirm the existence and quantify the magnitude of trauma season, we conducted a retrospective cohort study. The Plastic Surgery divisional billing database was queried for Current Procedural Terminology (CPT) codes related to acute facial trauma. The outcome variable is monthly CPT code volume and calendar month is the predictor. Monthly CPT volume was tabulated for 120 consecutive months. Raw data were plotted as a time series and transformed as a ratio to the moving average. Autocorrelation was applied to the transformed dataset to detect yearly periodicity. Multivariable modeling quantified the proportion of volume variability (R2) attributable to yearly periodicity. Subanalysis assessed presence and strength of periodicity in 4 age groups. Patient identifiers, demographic information, surgeon, and date of surgery were collected as covariates. RESULTS: One thousand six hundred fifty eight CPT codes obtained through Plastic Surgery billing records were included. Mean age at presentation was 32.5 ± 16.3 years (range = 85.05). Monthly trauma-related CPT volume was highest in June-September and lowest in December-February. Time series analysis revealed yearly oscillation, in addition to a growth trend. Autocorrelation revealed statistically significant positive and negative peaks at a lag of 12 and 6 months, respectively, confirming the presence of yearly periodicity. Multivariable linear modeling revealed R2 attributable to periodicity of 0.23 (P = .008). Periodicity was strongest in younger populations and weaker in older populations. R2 = 0.25 for ages 0-17, R2 = 0.18 for ages 18-44, R2 = 0.16 for ages 45-64, and R2 = 0.034 for ages ≥ 65. CONCLUSION: Operative facial trauma volumes peak in the summer and early fall and reach a winter nadir. This periodicity is statistically significant and accounts for 23% of overall trauma volume variability at our Level 1 trauma hospital. Younger patients drive the majority of this effect. Our findings have implications for operative block time and personnel allocation, in addition to expectation management over the course of the year.

Evidence-Based Medicine for Mandible Fracture Repair: Current Controversies and Future Opportunities.

Mandibular fractures are among the most common facial fractures resulting from trauma. The nature of the injury, involved facial structures, presence of associated injuries, the dental status of the patient, comorbid conditions, and psychosocial context all must be considered by the surgeon when planning the optimal treatment for these patients. While consensus exists for many aspects of the management of mandibular trauma, some elements remain controversial. Three such topics-antibiotic therapy, treatment of subcondylar fractures, and management of the third molar-remain particularly controversial, with significant heterogeneity in practice patterns and without widely accepted evidence-based guidelines to standardize care. The goals of this work are to (1) review the historical perspective underlying these controversies, (2) summarize recent evidence shaping the current debate, and (3) highlight opportunities for continued efforts to identify best practices.

Gross total resection of spinal chondrosarcoma is associated with improved locoregional relapse-free survival and overall survival.

BACKGROUND: Spinal chondrosarcomas are rare malignant osseous tumors. The low incidence of spinal chondrosarcomas and the complexity of spine anatomy have led to heterogeneous treatment strategies with varying curative and survival rates. The goal of this study is to investigate prognostic factors for locoregional recurrence-free survival (LRFS) and overall survival (OS) comparing en bloc vs. piecemeal resection for the management of spinal chondrosarcoma. METHODS: We retrospectively identified patients who underwent curative-intent resection of primary and metastatic spinal chondrosarcoma over a 25-year period. Univariate and multivariate survival analyses were conducted with LRFS as primary endpoint and OS as secondary endpoint. LRFS and OS were modeled using the Kaplan-Meier method and assessed using Cox regression analysis. RESULTS: For 72 patients who underwent first resection, the median follow-up time was 5.1 years (95% CI 2.2-7.0). Thirty-three patients (45.8%) had en bloc resection, and 39 (54.2%) had piecemeal resection. Of the 68 patients for whom extent of resection was known, 44 patients had gross total resection (GTR) and 24 patients had subtotal resection. In survival analyses, both LRFS and OS showed statistically significant difference based on the extent of resection (p = 0.001; p = 0.04, respectively). However, only LRFS showed statistically significant difference when assessing the type of resection (p = 0.02). In addition, higher tumor grade and more invasive disease were associated with worse LRFS and OS rates. CONCLUSION: Although in our study en bloc and GTR were associated with improved survival, heterogenous and complex spinal presentations may limit total resection. Therefore, the surgical management should be tailored individually to ensure the best local control and maximum preservation of function.

A Contemporary Review of the Role of Facial Prostheses in Complex Facial Reconstruction.

BACKGROUND: Maxillofacial prostheses provide effective rehabilitation of complex facial defects as alternatives to surgical reconstruction. Although facial prostheses provide aesthetically pleasing reconstructions, multiple barriers exist that prevent their routine clinical use. The accessibility of facial prostheses is limited by the scarce supply of maxillofacial prosthodontists, significant time commitment and number of clinic appointments required of patients during prosthesis fabrication, short lifespan of prostheses, and limited outcomes data. METHODS: A literature review was completed using PubMed and Embase databases, with search phrases including face and maxillofacial prostheses. Patient cases are included to illustrate the use of facial prostheses to reconstruct complex facial defects. RESULTS: The clinical use of facial prostheses requires a multidisciplinary team including a reconstructive surgeon, a maxillofacial prosthodontist, and an anaplastologist, if available, to provide patients with aesthetically appropriate facial prostheses. Developing technology including computer-aided design and three-dimensional printing may improve the availability of facial prostheses by eliminating multiple steps during prosthesis fabrication, ultimately decreasing the time required to fabricate a prosthesis. In addition, enhanced materials may improve prosthesis durability. Long-term outcomes data using validated measures is needed to support the continued use of facial prostheses. CONCLUSIONS: Facial prostheses can be used to reconstruct complex facial defects, and bone-anchored prostheses are associated with high patient satisfaction. Multiple barriers prevent prostheses from being used for facial reconstruction. New technologies to assist the design and fabrication of prostheses, and cost reduction measures, may allow their use in the appropriately selected patient.

Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis.

OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial. METHODS: The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory. RESULTS: A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4-5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°). CONCLUSIONS: This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study.

STUDY DESIGN: Prospective randomized Food and Drug Administration investigational device exemption clinical trial. OBJECTIVE: The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device. SUMMARY OF BACKGROUND DATA: Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty. METHODS: Standard demographic information was collected for each patient. Radiographic parameters and patient-reported outcome measures were assessed preoperatively and at regular postoperative intervals. Complication and reoperation data were also collected for each patient. RESULTS: At the time of this study, 153 patients had undergone implantation of the TOPS device. The mean surgical time was 187.8 minutes and the mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean Oswestry Disability Index, Visual Analog Score leg and back, and Zurich Claudication Questionnaire scores improved significantly at all postoperative time points ( P >0.001). There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device. Nine patients (5.9%) underwent a total of 13 reoperations, 1 (0.6%) of which was for device-related failure owing to bilateral L5 pedicle screw loosening. CONCLUSIONS: Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all patient-reported outcome measures and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate.