Comparing the Efficacy of Radiation Free Machine-Vision Image-Guided Surgery With Traditional 2-Dimensional Fluoroscopy: A Randomized, Single-Center Study.

Background: Three-dimensional (3D) computer-assisted navigation (CAN) has emerged as a potential alternative to 2-dimensional (2D) fluoroscopy in the surgical placement of spinal instrumentation. Recently, 3D-CAN systems have improved significantly in their ability to provide real-time anatomical referencing while shortening the registration and set-up time. A novel system in navigation, Machine-Vision Image-Guided Surgery (MvIGS; 7D Surgical, Toronto, Canada) was cleared by the US Food and Drug Administration, but its potential benefits in reducing intra-operative radiation exposure to patients and enhancing surgical accuracy of pedicle screw placement are not fully known. Purpose: We sought to conduct a prospective, randomized, clinical study comparing the 3D-MvIGS spinal navigation system and 2D-fluoroscopy for pedicle screw insertion up to 3 levels (T10-S1) and for various measures of surgical efficacy. Methods: Sixty-two eligible patients were randomized to receive spine surgery using either the 3D-MvIGS group or the conventional 2D-fluoroscopy for pedicle screw fixation for the treatment of spinal stenosis and degenerative spondylolisthesis. Intra-operative parameters and procedure-related unintended protocol violations were recorded. Results: Operative time and estimated blood loss were not significantly different between groups. Radiation time and exposure to patients were significantly reduced in the 3D-MvIGS group. There was no difference between groups in pedicle screw placement accuracy (2D-fluoroscopy group, 96.6%; 3D-MvIGS group, 94.2%). There were no major complications or cases that required revision surgery. Conclusion: The 3D-MvIGS navigation system performed comparably with 2D-fluoroscopy in terms of pedicle screw placement accuracy and operative time. The 3D-MvIGS showed a significant reduction in radiation exposure to patients. In more complex cases or larger cohorts, the true value of greater anatomical visualization can be elucidated.

Interlaminar stabilization for spinal stenosis in the Medicare population.

BACKGROUND CONTEXT: The number of complex fusions performed on Medicare beneficiaries, defined as ≥age 65, with lumbar spinal stenosis with or without spondylolisthesis has been increasing. Typically, these procedures are longer, more invasive and pose a greater risk for complications. Interlaminar stabilization (ILS) serves as an intermediary between decompression alone and decompression with fusion. PURPOSE: The purpose of this study was to prospectively examine the efficacy of ILS in patients ≥age 65 through comparison to fusion in the same age group and ILS in younger patients. STUDY DESIGN/SETTING: A prospective, multicentered, randomized controlled trial comparing decompression with ILS to decompression with posterolateral fusion with bilateral pedicle screw instrumentation. PATIENT SAMPLE: Patients from 21 sites in the United States underwent surgery for moderate stenosis with up to a grade 1 degenerative spondylolisthesis and failure of conservative treatment with low back pain at 1 or 2 contiguous levels from L1-L5. Preoperatively, patient-reported assessment had to meet the criteria of significant pain and disability (Visual Analog Scale [VAS back pain] ≥50 mm on a 100 mm scale; Oswestry Disability Index [ODI] of ≥20/50). OUTCOME MEASURES: The primary outcome was overall Composite Clinical Success (CCS) as determined by ODI scores, incidence of postoperative epidural injections and/or reoperations, incidence of device-related complications, and persistent or progressive neurological deficit. Secondary outcomes included patient satisfaction as measured by VAS for back and worse leg pain and Zurich Claudication Questionnaire scores. Narcotic usage data and radiographic assessment of changes in postoperative posterior disc height and foraminal height were also evaluated. METHODS: At 1- or 2-levels, 84 patients ≥age 65 underwent decompression with ILS, 57 patients ≥age 65 underwent decompression with fusion, and 131 patients

Single-center, consecutive series study of the use of a novel platelet-rich fibrin matrix (PRFM) and beta-tricalcium phosphate in posterolateral lumbar fusion.

PURPOSE: To evaluate the radiographic and clinical outcomes of the combination of platelet-rich fibrin matrix (PRFM) with beta-tricalcium phosphate (ß-TCP) and bone marrow aspirate (BMA) as a graft alternative in posterolateral lumbar fusion procedures. METHODS: Researchers evaluated 50 consecutive patients undergoing one-level to three-level posterolateral lumbar fusion procedures, resulting in a total of 66 operated levels. The primary outcome was evidence of radiographic fusion at 1-year follow-up, assessed by three independent evaluators using the Lenke scoring system. Secondary outcomes included back and leg VAS scores, incidence of reoperations and complications, return-to-work status, and opioid use. RESULTS: At 1-year follow-up, radiographic fusion was observed in 92.4% (61/66) of operated levels. There was significant improvement in VAS scores for both back and leg pain (p < 0.05). Compared to baseline figures, the number of patients using opioid analgesics at 12-months decreased by 38%. The majority (31/50) of patients were retired, yet 68% of employed patients (n = 19) were able to return to work. No surgical site infections were noted, and no revision surgery at the operated level was required. CONCLUSIONS: This is the first report to analyze the combination of PRFM with ß-TCP and BMA for PLF procedures. Our results indicate a rate of fusion similar to those reported using iliac crest bone graft (ICBG), while avoiding donor site morbidity related to ICBG harvesting such as hematoma, pain, and infection. These slides can be retrieved under Electronic Supplementary Material.

Split-Depressed Lateral Tibial Plateau Fractures: A Comparison of Augmented Percutaneous Screws Versus Augmented Plate and Screw Construct in a Cadaveric Model.

OBJECTIVES: To compare the strength of fixation of percutaneous screw versus plate/screw fixation in a paired cadaver model of OTA 41-B3 (Schatzker type II) split-depression fractures of the lateral tibial plateau. METHODS: Six matched pairs of cadaveric knees were acquired. An OTA 41-B3 (Schatzker type II) split-depression fracture was created in all specimens using a standardized method. One specimen from each matched pair of knees was fixed with percutaneous screws, and the other was fixed with a plate/screw construct. All specimens underwent augmentation of the central metaphyseal defect with calcium phosphate. Mean residual displacement (depression) was measured on thin-slice high-resolution computed tomography using a standardized methodology following 3 experimental conditions: (1) after they were fixed, before loading; (2) unloaded cycling (simulating postoperative range of motion exercises); and (3) loaded cycling (simulating postoperative weight-bearing). Load to failure was also compared. RESULTS: After adjustment for baseline measurements, there was no significant difference in mean residual depression of the lateral tibial plateau between treatments groups after unloaded or loaded cyclic testing. Mean residual depression was less than 1 mm in both the treatment groups. Load to failure was statistically equivalent between treatment groups. CONCLUSIONS: In our cadaveric study, in combination with calcium phosphate augmentation for both methods, percutaneous screw fixation conferred comparable strength of fixation compared with plate/screw constructs for treatment of OTA 41-B3 (Schatzker type II) tibial plateau fractures.

ISASS Recommendations and Coverage Criteria for Bone Graft Substitutes used in Spinal Surgery.

Autologous bone graft remains the gold standard by which bone graft substitutes are compared in spine fusion surgery. The utilization of bone graft substitutes, either as (1) an extender for spinal fusion constructs or (2) an alternative to minimize morbidity while maximizing outcomes, is changing. Moreover, current procedures technology (CPT) code 20939 became effective in 2018 defining bone marrow aspirate for bone grafting, spine surgery only. Changes in the complex landscape of grafting materials have prompted ISASS to provide category guidance for bone graft substitutes by comparing and contrasting US regulatory pathways, mechanisms of action, and supportive clinical evidence for these bone grafting materials.

Efficacy comparison of Accell Evo3 and Grafton demineralized bone matrix putties against autologous bone in a rat posterolateral spine fusion model.

BACKGROUND CONTEXT: Spinal fusion procedures are intended to stabilize the spinal column for a multitude of disorders including abnormal curvature, traumatic instability, degenerative instability, and damage from infections or tumors. As an aid in the bone healing response, bone graft materials are used to bridge joints for arthrodesis and promote unions in pseudoarthrosis. Currently, the gold standard for stabilizing fusion masses in spinal procedures involves using the osteogenic, osteoinductive, and osteoconductive properties of autologous iliac crest corticocancellous bone. However, considerable morbidity is associated with harvesting the autologous graft. Donor site complications including infection, large hematomas, and pain have been reported at rates as high as 50% (Boden and Jeffrey, 1995). Biologically, the rate of bone repair dictates the rate at which the fusion mass will unite under autologous graft conditions. PURPOSE: The purpose of this study is to compare the quality and rate of fusion between Accell Evo3 and Grafton demineralized bone matrix (DBM), with the gold standard iliac crest bone graft (ICBG) as the control, in athymic rat posterolateral fusion. STUDY DESIGN: This study was a randomized, controlled study in a laboratory setting at the Hospital for Special Surgery in New York City. Blinded observations were made, which created an assessment of outcomes for successful fusions between each method. PATIENT SAMPLE: Forty-eight (48) athymic rats were used in this study and underwent posterolateral lumbar fusion. They were assessed at either 3 weeks or 9 weeks to see the rate and efficacy of fusion. OUTCOME MEASURES: Outcome measures will be the efficacy of the different bone grafts and their success rates of fusion in the rats. METHODS: A comparison of the quality and rate of fusion between Accell Evo3® (DBM A) and Grafton (DBM B), with the gold standard iliac crest bone graft (ICBG) as the control, was performed using the established posterolateral intertransverse process on an athymic rat model. Materials were evaluated for fusion by several criteria, including manual palpation, standard and high-resolution radiographic imaging, micro-computed topography, and histologic analysis. Forty-eight (48) athymic rats received a bilateral intertransverse process fusion, using either bone from the iliac crest (control group), Accell Evo3, or Grafton. Twelve (12) rats (four from each group) were sacrificed at 3 weeks postoperatively, whereas the remaining thirty-six (36) were sacrificed at 9 weeks postoperatively. Three blinded observers examined the spines after the rats were euthanized, and they blindly assessed each rat for fusion success. RESULTS: Manual palpation of the three different groups at 3 weeks postoperatively found successful fusion in 1 of 4 (25%) of the autologous bone graft (ABG) group and 4 of 4 (100%) of both DBM A and B groups. Manual palpation of the remaining animals that were sacrificed at 9 weeks postoperatively showed successful fusion in 4 of 12 (33%) of the ABG group, 8 of 12 (66%) of the DBM A group, and 12 of 12 (100%) of the DBM B group. Radiography found that 9 of 16 (56%) of the ABG group and 16 of 16 (100%) of both DBM Putty A and B groups had fused. Histologic analysis of the ABG group demonstrated less mature and less organized osteoid at both 3 and 9 weeks than the DBM Putty A and B groups. Nondestructive mechanical testing demonstrated increased stiffness in 4-point bending of both DBM A and B compared with ABG. CONCLUSIONS: Both DBM-treated groups achieved a significantly higher rate of fusion than the ABG-treated group at 9 weeks in this model. Successful fusion was also demonstrated in the DBM-treated groups at 3 weeks.

Evaluation of a new formulation of demineralized bone matrix putty in a rabbit posterolateral spinal fusion model.

BACKGROUND CONTEXT: Alternatives to autologous bone graft (ABG) with osteoconductive, osteoinductive, and osteogenic potential continue to prove elusive. Demineralized bone matrix (DBM) however, with its osteoconductive and osteoinductive potential remains a viable option to ABG in posterolateral spine fusion. PURPOSE: To compare the efficacy of a new formulation of DBM putty with that of ABG in a rabbit posterolateral spinal fusion model. STUDY DESIGN: Efficacy of a new formulation of DBM was studied in an experimental animal posterolateral spinal fusion model. METHODS: Twenty-four male New Zealand White rabbits underwent bilateral posterolateral spine arthrodesis of the L5-L6 intertransverse processes, using either ABG (control group, n=12) or DBM (DBM made from rabbit bone) putty (test group, n=12). The animals were killed 12 weeks after surgery and the lumbar spines were excised. Fusion success was evaluated by manual palpation, high resolution X-rays, microcomputed tomography imaging, biomechanical four-point bending tests, and histology. RESULTS: Two animals were lost because of anesthetic related issues. Manual palpation to assess fusion success in the explanted lumbar spines showed no statistical significant difference in successful fusion in 81.8% (9/11) of DBM group and 72.7% (8/11) of ABG group (p=.99). Reliability of these assessments was measured between three independent observers and found near perfect agreement (intraclass correlation cofficient: 0.92 and 0.94, respectively). Fusion using high resolution X-rays was solid in 10 of the DBM group and 9 of the ABG group (p=.59). Biomechanical testing showed no significant difference in stiffness between the control and test groups on flexion, extension, and left lateral and right lateral bends, with p values accounting for .79, .42, .75, and .52, respectively. The bone volume/total volume was greater than 85% in the DBM treated fusion masses. Histologic evaluation revealed endochondral ossification in both groups, but the fusion masses were more mature in the DBM group. CONCLUSIONS: The DBM putty achieved comparable fusion rates to ABG in the rabbit posterolateral spinal fusion model.