In vivo study of a novel 3D-printed motion-preservation artificial cervical corpectomy construct: short-term imaging and biocompatibility evaluations in a goat model.

BACKGROUND: Nonfusion technologies, such as motion-preservation devices, have begun a new era of treatment options in spine surgery. Motion-preservation approaches mainly include total disc replacement for anterior cervical discectomy and fusion. However, for multisegment fusion, such as anterior cervical corpectomy and fusion, the options are more limited. Therefore, we designed a novel 3D-printed motion-preservation artificial cervical corpectomy construct (ACCC) for multisegment fusion. The aim of this study was to explore the feasibility of ACCC in a goat model. METHODS: Goats were treated with anterior C3 corpectomy and ACCC implantation and randomly divided into two groups evaluated at 3 or 6 months. Radiography, 3D CT reconstruction and MRI evaluations were performed. Biocompatibility was evaluated using micro-CT and histology. RESULTS: Postoperatively, all goats were in good condition, with free neck movement. Implant positioning was optimal. The relationship between facet joints was stable. The range of motion of the C2-C4 segments during flexion-extension at 3 and 6 months postoperatively was 7.8° and 7.3°, respectively. The implants were wrapped by new bone tissue, which had grown into the porous structure. Cartilage tissue, ossification centres, new blood vessels, and bone mineralization were observed at the porous metal vertebrae-bone interface and in the metal pores. CONCLUSIONS: The ACCC provided stabilization while preserving the motion of the functional spinal unit and promoting bone regeneration and vascularization. In this study, the ACCC was used for anterior cervical corpectomy and fusion (ACCF) in a goat model. We hope that this study will propel further research of motion-preservation devices.

Flexible posterior vertebral tethering for the management of Scheuermann's kyphosis: correction by using growth modulation-clinical and radiographic outcomes of the first 10 patients with at least 3 years of follow-up.

PURPOSE: The present prospective cohort study was intended to present the minimum 3 years' results of flexible posterior vertebral tethering (PVT) applied to 10 skeletally immature patients with SK to question, if it could be an alternative to fusion. METHODS: Ten skeletally immature patients with radiographically confirmed SK, who had flexible (minimum 35%) kyphotic curves (T2-T12), were included. A decision to proceed with PVT was based on curve progression within the brace, and/or persistent pain, and/or unacceptable cosmetic concerns of the patient/caregivers, and/or non-compliance within the brace. RESULTS: Patients had an average age of 13.1 (range 11-15) and an average follow-up duration of 47.6 months (range 36-60). Posterior vertebral tethering (PVT) was undertaken to all patients by utilizing Wiltse approach and placing monoaxial pedicle screws intermittently. At the final follow-up: mean pre-operative thoracic kyphosis and lumbar lordosis improved from 73.6°-45.7° to 34.7°-32.1°. Mean sagittal vertical axis, vertebral wedge angle and total SRS-22 scores improved significantly. A fulcrum lateral X-ray obtained at the latest follow-up, showed that the tethered levels remained mobile. CONCLUSION: This study, for the first time in the literature, concluded, that as a result of growth modulation applied to skeletally immature patients with SK, flexible PVT was detected to yield gradual correction of the thoracic kyphosis by reverting the pathological vertebral wedging process, while keeping the mobility of the tethered segments in addition to successful clinical-functional results. The successful results of the present study answered the role of the PVT as a viable alternative to fusion in skeletally immature patients with SK. LEVEL OF EVIDENCE: IV.

The efficacy of anterior vertebral body tethering in lenke type 6 curves for adolescent idiopathic scoliosis.

PURPOSE: Spinal fusion is the standard treatment for severe forms of adolescent idiopathic scoliosis (AIS). However, with the lowest instrumented vertebra that is usually located at L3 or L4, patients are prone to develop adjacent segment degeneration in the long term. Vertebral body tethering (VBT) as motion preserving technique has become an alternative for select patients with AIS. Several studies have presented the outcome after thoracic VBT but no study has analyzed the outcome after VBT for Lenke type 6 curves. METHODS: This is a retrospective single center data analysis of patients who have had bilateral VBT for Lenke type 6 curves and a minimum follow up of 24 months. Radiographic analysis was performed on several time points. Suspected tether breakages were additionally analyzed with respect to location and time at occurrence. RESULTS: 25 patients were included. Immediate thoracic curve correction was 55.4% and 71.7% for TL/L curves. Loss of correction was higher for TL/L curves and resulted in a correction rate of 48.3% for thoracic curves and 48.9% for TL/L curves at 24 months post-operatively. 22 patients were suspected to have at least one segment with a tether breakage. Three patients required a re-VBT but no patient received posterior spinal fusion. CONCLUSION: Bilateral VBT for Lenke type 6 curves is feasible and shows a significant curve correction for thoracic and TL/L curves at a minimum of 24 months post-operatively. Tether breakage rate and loss of correction remain an unfavorable observation that needs to be improved in the future.

Early-term outcome of apical fusion with vertebral body tethering for thoracolumbar curves in adolescent idiopathic scoliosis: a preliminary study.

INTRODUCTION: Vertebral body tethering (VBT) has become an alternative option for select patients with idiopathic scoliosis. However, studies have shown a high number of tether breakages, specifically after thoracolumbar (TL) VBT, that can have a negative impact on the outcome, when the breakage occurs within the first year after surgery. In order to overcome this problem, we have started to apply an apical fusion (AF) in combination with TL VBT for select patients. This study aims to analyze the outcome after AF plus VBT. METHODS: This is a retrospective single surgeon's data analysis. All patients were included who have had TL VBT after January 2022 and a follow-up of 12 months. Patients were grouped based on whether they only had VBT or VBT + AF. RESULTS: Twenty-five patients were analyzed (15 VBT, 10 VBT + AF). Both groups showed a significant curve correction for thoracic and TL curves. Minor loss of correction was observed in both groups. A significant difference was seen regarding early tether breakages, which were found in 60% of VBT patients and 10% of VBT + AF patients. CONCLUSION: The preliminary data shows a significant reduction of early tether breakages when TL VBT is applied in combination with AF.

A prospective study of lumbar facet arthroplasty in the treatment of degenerative spondylolisthesis and stenosis: cost-effective assessment from the Total Posterior Spine system (TOPSTM) IDE Study: 2-year model revision and sensitivity analyses based on 305 subjects.

BACKGROUND CONTEXT: A previous cost-effectiveness analysis published in 2022 found that the Total Posterior Spine (TOPSTM) system was dominant over transforaminal lumbar interbody fusion (TLIF). This analysis required updating to reflect a more complete dataset and pricing considerations. PURPOSE: To evaluate the cost-effectiveness of TOPSTM system as compared with TLIF based on an updated and complete FDA investigational device exemption (IDE) data set. STUDY DESIGN/SETTING: Cost-utility analysis of the TOPSTM system compared to TLIF. PATIENT SAMPLE: A multicenter, FDA IDE, randomized control trial (RCT) investigated the efficacy of TOPSTM compared to TLIF with a current population of n=305 enrolled and n=168 with complete 2-year follow-up. OUTCOME MEASURES: Cost and quality adjusted life years (QALYs) were calculated to determine our primary outcome measure, the incremental cost-effectiveness ratio. Secondary outcome measures included: net monetary benefit as well at willingness-to-pay (WTP) thresholds. METHODS: The primary outcome of cost-effectiveness is determined by incremental cost-effectiveness ratio. A Markov model was used to simulate the health outcomes and costs of patients undergoing TOPSTM or TLIF over a 2-year period. alternative scenario sensitivity analysis, one-way sensitivity analysis, and probabilistic sensitivity analysis were conducted to assess the robustness of the model results. RESULTS: The updated base case result demonstrated that TOPSTM was immediately and longitudinally dominant compared with the control with an incremental cost-effectiveness ratio of -9,637.37 $/QALY. The net monetary benefit was correspondingly $2,237, both from the health system's perspective and at a WTP threshold of 50,000 $/QALY at the 2-year time point. This remained true in all scenarios tested. The Alternative Scenario Sensitivity Analysis suggested cost-effectiveness irrespective of payer type and surgical setting. To remain cost-effective, the cost difference between TOPSTM and TLIF should be no greater than $1,875 and $3,750 at WTP thresholds of $50,000 and 100,000 $/QALY, respectively. CONCLUSIONS: This updated analysis confirms that the TOPSTM device is a cost-effective and economically dominant surgical treatment option for patients with lumbar stenosis and degenerative spondylolisthesis compared to TLIF in all scenarios examined.

Cadaveric biomechanical studies of ADDISC total lumbar disc prosthesis.

BACKGROUND: Most total disc replacements provide excessive mobility and not reproduce spinal kinematics, inducing zygapophyseal joint arthritic changes and chronic back pain. In cadaveric lumbosacral spines, we studied if a new lumbar disc prosthesis kinematics mimics the intact intervertebral disc. METHODS: In eight cold preserved cadaveric lumbosacral spines, we registered the movement ranges in flexion, extension, right and left lateral bending, and rotation in the intact status, post-discectomy, and after our prosthesis implantation, comparing them for each specimen. FINDINGS: Comparing the intact lumbosacral spine with the L4-L5 prosthesis implanted specimens, we saw statistically significant differences in lateral bending and right rotation but not in the full range of rotation. Analyzing segments, we also noticed statistically significant differences at L4-L5 in flexion-extension and rotation. On the other hand, the L4-L5 discectomy, compared to the baseline spine condition, showed a statistically significant mobility increase in flexion, extension, lateral bending, and axial rotation, with an abnormal instantaneous center of rotation, which destabilizes the segment partly due to anterior annulus surgical removal. Disc prosthesis implantation reversed these changes in instantaneous center of rotation, but the prosthesis failed to restore the initial range of motion due to the destabilization of the ligaments in the operated disc. INTERPRETATION: The ADDISC total disc replacement reproduces the intact disc kinematics and Instantaneous Center of Rotation, but the prosthesis fails to restore the initial range of motion due to ligament destabilization. More studies will be necessary to define a technique that restores the damaged ligaments when implanting the prosthesis.

Prospective, multicenter clinical trial comparing the M6-C compressible cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 5-year results of an FDA investigational device exemption study.

BACKGROUND CONTEXT: Various total disc replacement (TDR) designs have been compared to anterior cervical discectomy and fusion (ACDF) with favorable short and long-term outcomes in FDA-approved investigational device exemption (IDE) trials. The unique design of M6-C, with a compressible viscoelastic nuclear core and an annular structure, has previously demonstrated favorable clinical outcomes through 24 months. PURPOSE: To evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare to ACDF at 5 years. STUDY DESIGN: Prospective, multicenter, concurrently and historically controlled, FDA-approved IDE clinical trial. PATIENT SAMPLE: Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and received M6-C (n=160) or ACDF (n=189) treatment as part of the IDE study. Safety outcomes were evaluated at 5 years for all subjects. The primary effectiveness endpoint was available at 5 years for 113 M6-C subjects and 106 ACDF controls. OUTCOME MEASURES: The primary endpoint of this analysis was composite clinical success (CCS) at 60 months. Secondary endpoints were function and pain (neck disability index, VAS), physical quality of life (SF-36, SF-12), safety, neurologic, and radiographic assessments. METHODS: Propensity score subclassification was used to control for selection bias and match baseline covariates of the control group to the M6-C subjects. Sixty-month CCS rates were estimated for each treatment group using a generalized linear model controlling for propensity score. RESULTS: At 5 years postoperatively, the M6-C treatment resulted in 82.3% CCS while the ACDF group showed 67.0% CCS (superiority p=.013). Secondary endpoints indicated that significantly more M6-C subjects achieved VAS neck and arm pain improvements and showed maintained or improved physical functioning on quality-of-life measures compared to baseline assessments. The M6-C group-maintained flexion-extension motion, with significantly greater increases from baseline disc height and disc angle than observed in the control group. The rates of M6-C subsequent surgical interventions (SSI; 3.1%) and definitely device- or procedure-related serious adverse events (SAE failure; 3.1%) were similar to ACDF rates (SSI=5.3%, SAE failure=4.8%; p>.05 for both). CONCLUSIONS: Subjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls. In addition, significantly more subjects in the M6-C group showed improved pain and physical functioning scores than observed in ACDF subjects, with no difference in reoperation rates or safety outcomes.

Cervical disc arthroplasty with the Baguera C prosthesis: clinical and radiological results of a 10-year follow-up study.

PURPOSE: We evaluated the long-term safety, mobility and complications of cervical total disc arthroplasty with the Baguera®C prosthesis over 10 years. METHODS: We included 91 patients treated by arthroplasty for cervical degenerative disc disease. A total of 113 prostheses were implanted (50 one-level, 44 two-level and 19 hybrid constructs). They were assessed for complications, clinically, with NDI and SF-12 questionnaires and by independent radiologists for ROM, HO, disc height and adjacent level degeneration. RESULTS: No spontaneous migration, loss of fixation, subsidence, vascular complication or dislocation were observed. The reoperation rate was 1%. About 82.7% of the patients were pain free. About 9.9% were taking occasional grade I painkillers. Motricity and sensitivity were preserved in 98.8% and 96.3%. The NDI showed an average functional disability of 17.58%, 26% lower than preoperatively. The SF-12 scores were close to normal health. The average ROM at the treated level was 7.4°. Motion was preserved in 86.6%. Lack of motion was observed in 13.4%. Grades II and III H0 were present in 53.7% and 31.7%, respectively, Grade IV was present in 13.4%. Motion was preserved in 100% of the grades 0-III. The preoperative adjacent level disc height of 4.3 mm remained stable during all the follow-ups at 4.4 mm and 4.2 mm, respectively, at 5 and 10 years. CONCLUSIONS: After 10 years, cervical arthroplasty with the Baguera®C prosthesis presents excellent safety and functional results and low complications. Motion was preserved in 86.6%, with a 7.4° ROM. Although common, HO did not hinder motion. Adjacent disc height preservation confirms some adjacent level degeneration protection.

Radiological factors affecting functional outcome after the implantation of BDYN™ dynamic stabilization system for low-grade lumbar degenerative spondylolisthesis.

BACKGROUND: The objectives of this study are to identify radiological factors associated with good functional outcomes after the implantation of BDYN™ dynamic stabilization system in the setting of painful low-grade degenerative lumbar spondylolisthesis (DLS). MATERIAL AND METHODS: In this monocentric, retrospective study, we followed 50 patients, a 5-years period, with chronic lower back pain, radiculopathy and/or neurogenic claudication evolving for at least one year that failed conservative treatment. All patients presented low-grade DLS and underwent lumbar dynamic stabilization. Radiological and clinical outcomes were assessed preoperatively and 24months after surgery. Functional evaluation was based on the Oswestry Disability Index (ODI), the Numerical Rating Scale (NRS), and the Walking Distance (WD). Radiological analysis was based on lumbar X-rays and MRI parameters. Patients were divided into two groups according to the reduction in the postoperative ODI score (more or less than 15 points), and statistical analysis was performed between both groups to find predictive radiological factors for a satisfying functional outcome. RESULTS: Clinically, 80% (40 patients) had a satisfying functional result, and 20% (10 patients) were considered having a poor outcome according to the ODI score. Radiologically, the loss in segmental lordosis was statistically associated with bad functional outcomes (18° for ODI decrease>15 versus 11° for ODI decrease<15). There is also a tendency showing that a higher Pfirmann disc signal grade (grade IV) and a severe canal stenosis according to Schizas classification (grade C & D) are predictive of a poor clinical result, but that must be confirmed in future studies. CONCLUSIONS: BDYN™ appears safe and well-tolerated. This new device should be effective for the treatment of patients with low-grade DLS. It provides significant improvement in terms of daily life activity and pain. Moreover, we have been able to deduce that a kyphotic disc is associated with a bad functional outcome after BDYN™ device implantation. It may represent a contraindication for the implantation of such DS device. Moreover, it seems that it is better to implant BDYN™ in DLS with mild or moderate disc degeneration and canal stenosis.

Radiographic outcome after vertebral body tethering of the lumbar spine.

INTRODUCTION: Multiple studies have analyzed the outcome after thoracic Vertebral Body Tethering (VBT). The results seem reproducible with most studies reporting coronal correction rates around 50% and a tether breakage rate near 20% at two years follow-up. There is a paucity of data on lumbar VBT, and no study has yet analyzed the radiographic outcome after lumbar VBT in a double tether technique at two years follow-up, which was the aim of this study. METHODS: This is a retrospective, single surgeons' data analysis of all consecutive immature patients who have had VBT of the lumbar spine (to L3 or L4) between January 2019 and September 2020. Primary interest focused on coronal curve correction at two years post-operatively. Suspected tether breakages were analyzed separately and defined as an angular change of more than 5° between two adjacent screws. RESULTS: Forty-one patients were eligible for this study and 35 (85%) had complete two-year follow-up data. Average age at surgery was 14.3 years. All patients had a Sanders stage of 7 or below. Average curve correction for thoracolumbar/lumbar curves at two years follow-up was 50%. 90% of patients had at least one level with a suspected tether breakage. No patient required a revision surgery within two years from surgery but two patients were surgically revised after two years. CONCLUSION: VBT in the lumbar spine resulted in 50% coronal curve correction two years post-operatively despite a tether breakage in 90% of patients.

Bionate® nucleus disc replacement: bench testing comparing two different designs.

BACKGROUND: Intervertebral disc nucleus degeneration initiates a degenerative cascade and can induce chronic low back pain. Nucleus replacement aims to replace the nucleus while the annulus is still intact. Over time, several designs have been introduced, but the definitive solution continues to be elusive. Therefore, we aimed to create a new nucleus replacement that replicates intact intervertebral disc biomechanics, and thus has the potential for clinical applications. MATERIALS AND METHODS: Two implants with an outer ring and one (D2) with an additional midline strut were compared. Static and fatigue tests were performed with an INSTRON 8874 following the American Society for Testing and Materials F2267-04, F2346-05, 2077-03, D2990-01, and WK4863. Implant stiffness was analyzed at 0-300 N, 500-2000 N, and 2000-6000 N and implant compression at 300 N, 1000 N, 2000 N, and 6000 N. Wear tests were performed following ISO 18192-1:2008 and 18192-2:2010. GNU Octave software was used to calculate movement angles and parameters. The statistical analysis package R was used with the Deducer user interface. Statistically significant differences between the two designs were analyzed with ANOVA, followed by a post hoc analysis. RESULTS: D1 had better behavior in unconfined compression tests, while D2 showed a "jump." D2 deformed 1 mm more than D1. Sterilized implants were more rigid and deformed less. Both designs showed similar behavior under confined compression and when adding shear. A silicone annulus minimized differences between the designs. Wear under compression fatigue was negligible for D1 but permanent for D2. D1 suffered permanent height deformation but kept its width. D2 suffered less height loss than D1 but underwent a permanent width deformation. Both designs showed excellent responses to compression fatigue with no breaks, cracks, or delamination. At 10 million cycles, D2 showed 3-times higher wear than D1. D1 had better and more homogeneous behavior, and its wear was relatively low. It showed good mechanical endurance under dynamic loading conditions, with excellent response to axial compression fatigue loading without functional failure after long-term testing. CONCLUSION: D1 performed better than D2. Further studies in cadaveric specimens, and eventually in a clinical setting, are recommended. Level of evidence 2c.

An investigation of range of motion preservation in fusionless anterior double screw and cord constructs for scoliosis correction.

PURPOSE: To evaluate the motion-preserving properties of vertebral body tethering with varying cord/screw constructs and cord thicknesses in cadaveric thoracolumbar spines. METHODS: In vitro flexibility tests were performed on six fresh-frozen human cadaveric spines (T1-L5) (2 M, 4F) with a median age of 63 (59-to-80). An ± 8 Nm load was applied to determine range of motion (ROM) in flexion-extension (FE), lateral bending (LB), and axial rotation (AR) in the thoracic and lumbar spine. Specimens were tested with screws (T5-L4) and without cords. Single (4.0 mm and 5.0 mm) and double (4.0 mm) cord constructs were sequentially tensioned to 100 N and tested: (1) Single 4.0 mm and (2) 5.0 mm cords (T5-T12); (3) Double 4.0 mm cords (T5-12); (4) Single 4.0 mm and (5) 5.0 mm cord (T12-L4); (6) Double 4.0 mm cords (T12-L4). RESULTS: In the thoracic spine (T5-T12), 4.0-5.0 mm single-cord constructs showed slight reductions in FE and 27-33% reductions in LB compared to intact, while double-cord constructs showed reductions of 24% and 40%, respectively. In the lumbar spine (T12-L4), double-cord constructs had greater reductions in FE (24%), LB (74%), and AR (25%) compared to intact, while single-cord constructs exhibited reductions of 2-4%, 68-69%, and 19-20%, respectively. CONCLUSIONS: The present biomechanical study found similar motion for 4.0-5.0 mm single-cord constructs and the least motion for double-cord constructs in the thoracic and lumbar spine suggesting that larger diameter 5.0 mm cords may be a more promising motion-preserving option, due to their increased durability compared to smaller cords. Future clinical studies are necessary to determine the impact of these findings on patient outcomes.

Lumbar arthroplasty for treatment of primary or recurrent lumbar disc herniation.

PURPOSE: Microdiscectomy is the current gold standard surgical treatment for primary lumbar disc herniations that fail non-surgical measures. Herniated nucleus pulposus is the manifestation of underlying discopathy that remains unaddressed with microdiscectomy. Therefore, risk remains of recurrent disc herniation, progression of the degenerative cascade, and on-going discogenic pain. Lumbar arthroplasty allows for complete discectomy, complete direct and indirect decompression of neural elements, restoration of alignment, restoration of foraminal height, and preservation of motion. In addition, arthroplasty avoids disruption of posterior elements and musculoligamentous stabilizers. The purpose of this study is to describe the feasibility of the use of lumbar arthroplasty in the treatment of patients with primary or recurrent disc herniations. In addition, we describe the clinical and peri-operative outcomes associated with this technique. METHODS: All patients that underwent lumbar arthroplasty by a single surgeon at a single institution from 2015 to 2020 were reviewed. All patients with radiculopathy and pre-operative imaging demonstrating disc herniation that received lumbar arthroplasty were included in the study. In general, these patients were those with large disc herniations, advanced degenerative disc disease, and a clinical component of axial back pain. Patient-reported outcomes of VAS back, VAS leg, and ODI pre-operatively, at three months, one year, and at last follow-up were collected. Reoperation rate, patient satisfaction, and return to work were documented at last follow-up. RESULTS: Twenty-four patients underwent lumbar arthroplasty during the study period. Twenty-two (91.6%) patients underwent lumbar total disc replacement (LTDR) for a primary disc herniation. Two patients (8.3%) underwent LTDR for a recurrent disc herniation after prior microdiscectomy. The mean age was 40 years. The mean pre-operative VAS leg and back pain were 9.2 and 8.9, respectively. The mean pre-operative ODI was 22.3. Mean VAS back and leg pain was 1.2 and 0.5 at three months post-operative. The mean VAS back and leg pain was 1.3 and 0.6 at one year post-operative. The mean ODI was 3.0 at one year post-operative. One patient (4.2%) underwent re-operation for migrated arthroplasty device which required repositioning. At last follow-up, 92% of patients were satisfied with their outcome and would undergo the same treatment again. The mean time for return-to-work was 4.8 weeks. After returning to work, 89% of patients required no further leave of absence for recurrent back or leg pain at last follow-up. Forty-four percent of patients were pain free at last follow-up. CONCLUSION: Most patients with lumbar disc herniations can avoid surgical intervention altogether. Of those that require surgical treatment, microdiscectomy may be appropriate for certain patients with preserved disc height and extruded fragments. In a subset of patients with lumbar disc herniation that require surgical treatment, lumbar total disc replacement is an effective option by performing complete discectomy, restoring disc height, restoring alignment, and preserving motion. The restoration of physiologic alignment and motion may result in durable outcomes for these patients. Longer follow-up and comparative and prospective trials are needed to determine how the outcomes of microdiscectomy may differ from lumbar total disc replacement in the treatment of primary or recurrent disc herniation.

A Novel Treatment of Pediatric Atlanto-Occipital Dislocation with Nonfusion Using Muscle-Preserving Temporary Internal Fixation of C0-C2: Case Series and Technical Note.

Study Design Case series with surgical technical note. Objectives This article reports experiences and results of muscle-preserving temporary C0-C2 fixation for the treatment of atlanto-occipital dislocation (AOD). Methods AOD is a rare injury caused by high-energy trauma, occurring in less than 1% of pediatric trauma patients. Recommended treatment is C0-C2 fusion which, however, will result in significant loss of mobility in the craniocervical junction (CCJ), especially C1-C2 rotation. An alternative approach, with the ability of preserving mobility in the C1-C2 segment, is a temporary fixation that allows the ligaments to heal, after which the implants can be removed to regain function in the CCJ joints. By using a muscle-preserving approach and navigation for the C2 screws, a relatively atraumatic fixation of the CCJ can be achieved with motion recovery after implant removal. Results We present two cases of AOD treated with temporary fixation. A 12-year-old boy involved in a frontal car collision, as a strapped back seat passenger, was treated with temporary C0-C2 fixation for 10 months. Follow-up at 11 months after implant removal included clinical evaluation, computed tomography, magnetic resonance imaging (MRI), and flexion-extension X-rays. He was free of symptoms at follow-up. The CCJ was radiographically stable and he had 45 degrees of C1-C2 rotation. A 7-year-old girl was hit by a car as she got off a bus. She was treated with temporary fixation for 4 months after which the implant was removed. Follow-up at 8 years included clinical evaluation and MRI in rotation. She was free of symptoms. The ligaments of the CCJ appeared normal and her C1-C2 rotation was 30 degrees. Conclusion C0-C2 fixation without fusion allows the CCJ ligaments to heal in pediatric AOD. By removing the implants after ligament healing, rotation in the C1-C2 segment can be regained without subsequent instability. Both our patients tolerated the treatment well and were free of symptoms at follow-up. By using minimally invasive muscle-preserving technique and navigation, temporary fixation of the CCJ can be achieved with minimal damage to the soft tissues allowing recovery of almost normal function after implant removal.

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.

Range of motion after 1, 2, and 3 level cervical disc arthroplasty.

Background: Motion of a solid body involves translation and rotation. Few investigations examine the isolated translational and rotational components associated with disc arthroplasty devices. This study investigates single- and multi-level cervical disc arthroplasty with respect to index and adjacent level range of motion. The investigators hypothesized that single- and multilevel cervical disc replacement will lead to comparable or improved motion at implanted and adjacent levels. Methods: Seven human cervical spines from C2 to C7 were subjected to displacement-controlled loading in flexion, extension, and lateral bending under intact, 1-Level (C5-C6), 2-Level (C5-C6, C6-C7) and 3-Level (C5-C6, C6-C7, C4-C5) conditions. 3D motions sensors were mounted at C4, C5, and C6. Motion data for translations and rotations at each level for each surgical condition and loading mode were compared to intact conditions. Results: 1-Level: The index surgery resulted in statistically increased translations in extension and lateral bending at all levels with statistically increased translation observed in flexion in the superior and inferior levels. In rotation, the index surgeries decreased rotation under flexion, with remaining levels not statistically different to intact conditions. 2-Level: A device placed inferiorly resulted in statistically increased translations at all levels in extension with statistically increased translations superior and inferior to the index level in flexion. Lateral bending resulted in increased nonsignificant translations. Rotations were elevated or comparable to the intact level for all loading. 3-Level: Translations were statistically increased for all levels in all loading modes while rotations were elevated or were comparable to the intact level for all loading modes and levels. Conclusions: Micromotion sensors permitted monitoring and recording of small magnitude angulations and translations using a loading mechanism that did not over constrain cervical segmental motion. Multilevel cervical disc arthroplasty yielded comparable or increased overall motion at the index and adjacent levels compared to intact conditions.

Ceramics in total disc replacements: A scoping review.

BACKGROUND: Ceramics are used in Total Disc Replacements (1) in articulating surfaces for their wear resistance and biocompatibility and (2) on endplates to promote osseointegration. They furthermore exhibit MRI and CT compatibility. These properties address main challenges associated with non-ceramic Total Disc Replacements i.e. wear, migration and postoperative imaging. While brittleness of ceramics caused fear of fracture in the past, improvements of ceramic materials were made and considerable clinical experience with ceramic Total Disc Replacements was gained. This review aims to assess the evidence on the use of ceramics in Total Disc Replacements and compare safety and effectiveness of ceramic Total Disc Replacements to spinal fusion and Total Disc Replacements in general. METHODS: We conducted a scoping review on the use of ceramics in Total Disc Replacements using Scopus, Web of Science and PubMed. The review includes 36 clinical, ex vivo and nonhuman in vivo, tribological and mechanical studies and case reports. FINDINGS: Ceramics are used in cervical Total Disc Replacements, with safety and efficacy confirmed in clinical studies, with up to 10 and 3.3 years follow-up, for articulation and osseointegration applications, respectively. Clinical evidence shows that ceramic Total Disc Replacements (alike non-ceramic ones) restore segmental motion and result in non-inferior and possibly superior outcomes to spinal fusion. In vivo studies show osseointegration comparable to non-ceramic devices. Tribological studies suggest appropriate wear properties. INTERPRETATION: We found no indications of systematic problems with the use of ceramics in Total Disc Replacements. Ceramics are suitable materials for Total Disc Replacements.

Single-Level Total Disc Replacement: Index-Level and Adjacent-Level Revision Surgery Incidence, Characteristics, and Outcomes.

BACKGROUND: The literature reports that index level (IL) revision spine surgery (RSS) and adjacent level (AL) RSS are diminished in lumbar TDR compared with fusion procedures. There is a paucity of PROMs reported after RSS. OBJECTIVE: To present the incidence of RSS at the IL and AL following single-level lumbar total disc replacement (TDR) and to document patient-related outcome measures (PROMs) associated with RSS. METHODS: PROMs and timelines were analyzed for 32 RSS patients from a prospective cohort study of 401 patients treated with TDR for single-level degenerative disc disease. The data collected prospectively are analyzed from baseline (prior to index surgery) to latest follow-up following RSS. PROMs, including visual analog scales for back and leg, Oswestry Disability Index, and Roland-Morris Disability Questionnaire, were collected preoperatively; postoperatively at 3, 6, and 12 months; and annually thereafter until RSS. The time to RSS was recorded, and PROMs for RSS (IL, AL, or both) were documented, analyzed, and compared. RESULTS: The median time to RSS in the IL cohort was 35 months (interquartile range [IQR] = 9-51 months). The median time to RSS cohort was 70 months (IQR = 41.3-105.3 months). Timepoints facilitate PROM discussion for RSS. Patients in both groups achieved thresholds for the minimum clinically important difference for pain and disability scores. The small sample size in each group contributed to the variability demonstrated by the 95% CIs, thereby cautioning definitive conclusions. CONCLUSIONS: This study reveals that statistically significant and modest clinical improvements in PROMs can be achieved in RSS for lumbar TDR at IL and AL. The surgical approach and technique are reflective of the pathology and suggest that anterior RSS for AL degeneration and posterior RSS for IL pathology yield similar results. CLINICAL RELEVANCE: Statistical and clinical improvements can be achieved in IL-RSS and AL-RSS following single level TDR. It is essential for clinicians to understand and verify the underlying IL and/or AL pathology to select an appropriate management strategy and to facilitate balanced informed discussions with patients.

Single-Level Total Disc Replacement: Mid- to Long-Term Outcomes.

BACKGROUND: Total disc replacement (TDR) has been shown to be effective for the treatment of lumbar degenerative disc disease (DDD) in carefully selected patients. Previous studies have demonstrated high rates of patient satisfaction and improvement in patient-reported outcome measures (PROMs) compared with preoperative status but most have short-term follow-up or small cohort sizes only. OBJECTIVE: The aim of this study is to report mid- to long-term PROMs from the treatment of symptomatic single-level lumbar DDD with TDR. METHODS: Data collected prospectively concerning single-level TDR performed via an anterior approach were included for analysis. A preoperative assessment was obtained followed by postoperative follow-up assessments at 3, 6, and 12 months, and yearly follow-up thereafter. PROMs included patient satisfaction, visual analog score back and leg, Oswestry Disability Index, and Roland-Morris Disability Questionnaire. RESULTS: A total of 211 patients (118 men, 93 women) operated on between June 1997 and July 2015 were included in this study. Minimum follow-up was 4 years. The average age was 42.2 (range 24-87) years and median follow-up 96 interquartile range 72-132, range 48-120) months. The operative levels were L5-S1 (160, 75.8%) and L4-L5 (61, 24.2%). Both statistically and clinically significant improvements observed postoperatively were maintained at 10 years. In addition, 92% of patients reported either good (n = 29) or excellent satisfaction (n = 155) with treatment at final review. CONCLUSIONS: This study shows that single-level lumbar TDR used appropriately in selected patient results in clinically significant improvements in pain and function, well above the minimum clinically important difference, and good to excellent satisfaction in most patients. Further study to define long-term outcomes and survivorship is required. CLINICAL RELEVANCE: Statistically significant and clinically relevant improvements can be achieved by single-level lumbar TDR, in the treatment of single-level discogenic axial low back pain, with or without radiculopathy. These outcomes are sustained in the mid- to long-term followup periods.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-effective Assessment from the Total Posterior Spine System (TOPS™) IDE Study.

Background: Given the increased attention to functional improvement in spine surgery as it relates to motion preservation, activities of daily living, and cost, it is critical to fully understand the healthcare economic impact of new devices being tested in large FDA randomized controlled trials (RCT). The purpose of this analysis was to comprehensively evaluate the cost-effectiveness of the novel Total Posterior Spine (TOPS™) System investigational device compared with the trial control group, standard transforaminal lumbar interbody fusion (TLIF). Objective: To evaluate the cost-effectiveness of TOPS™ compared with TLIF. Methods: The study patient population was extracted from a multicenter RCT with current enrollment at n=121 with complete 1-year follow-up. The primary outcome was cost-effectiveness, expressed as the incremental cost-effectiveness ratio. Secondary outcomes were health-related utility, presented as quality-adjusted life-years (QALYs), and cost, calculated in US dollars. Analysis was conducted following Second Panel on Cost-Effectiveness Health and Medicine recommendations. The base case analysis utilized SF-36 survey data from the RCT. Both cost and QALY outcomes were discounted at a yearly rate of 3% to reflect their present value. A cohort Markov model was constructed to analyze perioperative and postoperative costs and QALYs for both TOPS™ and control groups. Scenario, probabilistic, and threshold sensitivity analyses were conducted to determine model discrimination and calibration. Results: The primary time horizon used to estimate cost and health utility was 2 years after index surgery. From a health system perspective, assuming a 50/50 split between Medicare and private payers, the TOPS™ cohort is cost-effective 2 years postoperatively ($6158/QALY) compared with control. At 6 years and beyond, TOPS™ becomes dominant, irrespective of payer mix and surgical setting. At willingness-to-pay thresholds of $100 000/QALY, 63% of all 5000 input parameter simulations favor TOPS, even with a $4000 upcharge vs TLIF. Discussion: The novel TOPS™ device is cost-effective compared with TLIF and becomes the dominant economic strategy over time. Conclusions: In the emerging, rapidly expanding field of value-based medicine, there will be an increased demand for these analyses, ensuring surgeons are empowered to make the best, most sustainable solutions for their patients and society.