Fusion rate of Escherichia coli-derived recombinant human bone morphogenetic protein-2 compared with local bone autograft in posterior lumbar interbody fusion for degenerative lumbar disorders.

BACKGROUND CONTEXT: The use of recombinant human bone morphogenetic proteins-2 (rhBMP-2) for spinal fusion has been reported to be effective. However, most studies have focused on posterolateral and anterior lumbar interbody fusion, and few have investigated posterior lumbar interbody fusion (PLIF). PURPOSE: This study aimed to determine the effectiveness and safety of the delivery of Escherichia coli-derived rhBMP-2 (E.BMP-2) with hydroxyapatite (HA) and ß-tricalcium phosphate (ß-TCP) poloxamer hydrogel composite carriers for PLIF. STUDY DESIGN: A retrospective study. PATIENT SAMPLE: Patients who underwent 1 to 3 levels of PLIF for lumbar degenerative disc disorders between 2015 and 2020 with a follow-up of ≥1 year were enrolled. In total, 254 patients (357 levels) were included in the analysis. The evaluation was performed at each segment level. In the E.BMP-2 group, 160 patients (221 levels) received autologous local bone with E.BMP-2 (maximum 0.5 mg/level), and in the control group, 94 patients (136 levels) received only local bone graft. OUTCOME MEASURES: The primary outcome of this study was to compare the X-ray and CT fusion rates between the two groups. Secondary outcomes included analysis of the patients' clinical outcomes and postoperative complications on CT scans. METHODS: Clinical evaluations were performed using a visual analog scale for back pain, the Oswestry Disability Index for disability, and physical and mental component summaries of the Short Form 36-Item Form Health Survey to assess functional effects and quality of life. The fusion was evaluated using radiography and CT. On radiography, solid fusion was defined when the difference between extension and flexion was less than 5°. On CT, solid fusion was defined when the upper and lower vertebral bodies were connected by the trabecular bone (bone bridge formation). In addition, complications such as osteolysis, cage subsidence, and screw loosening were investigated using CT. RESULTS: All clinical results for low back pain, disability, and quality of life in both groups were excellent and showed statistically significant improvements compared with baseline (p<.0001). According to the X-ray evaluations, fusion was achieved in 92.31% (204/221) of the patients in the E.BMP-2 group and 82.35% (112/136) of the patients in the control group (p=.0041). According to the CT evaluations, the fusion rates were 93.21% (206/221) and 88.24% (120/136) in the E.BMP-2 and control groups (p=.1048), respectively. Except for screw loosening, which had a significantly higher incidence in the control group (p=.0014), the rates of most postoperative complications were not significantly different between the groups. CONCLUSIONS: This study demonstrated that the adjunctive use of a low dose of E.BMP-2 with HA and ß-TCP hydrogel can effectively promote bone fusion, making it a promising option for patients with limited autograft availability or compromised bone quality in PLIF.

Single-Position Oblique Lumbar Interbody Fusion and Percutaneous Pedicle Screw Fixation under O-Arm Navigation: A Retrospective Comparative Study.

The insertion of pedicle screws in the lateral position without a position change has been reported. We completed a retrospective comparison of the radiologic and clinical outcomes of 36 patients who underwent either single-position oblique lateral lumbar interbody fusion (SP-OLIF) using the O-arm (36 cases) or conventional OLIF (C-OLIF) using the C-arm (20 cases) for L2-5 single-level lumbar degenerative diseases. Radiological parameters were analyzed, including screw accuracy (Gertzbein-Robbins classification system; GRS), segmental instability, and fusion status. Screw misplacement was defined as a discrepancy of ≥2 mm. Clinical outcomes, including visual analog scale, Oswestry Disability Index (ODI), 36-Item Short Form Health Survey (SF-36), and postoperative complications, were assessed. The spinal fusion rate was not different between the SP-OLIF and C-OLIF groups one year after surgery (p = 0.536). The ODI score was lower (p = 0.015) in the SP-OLIF than the C-OLIF group. Physical (p = 0.000) and mental component summaries (p = 0.000) of the SF-36 were significantly higher in the SP-OLIF group. Overall complication rates, including revision, surgical site infection, ipsilateral weakness, and radicular pain/numbness, were not significantly different. SP-OLIF using the O-arm procedure is feasible, with acceptable accuracy, fusion rate, and complication rate. This may be an alternative to conventional two-stage operations.

Efficacy and Safety of a Thrombin-Containing Collagen-Based Hemostatic Agent in Spinal Surgery: A Randomized Clinical Trial.

OBJECTIVE: When common hemostatic methods, such as suturing, cautery, and compression, fail to arrest bleeding during surgery, various local hemostatic agents are used. We aimed to evaluate the hemostatic efficacy and safety of CollaStat (Dalim Tissen Co. Ltd., Seoul, Korea), a novel thrombin-containing, collagen-based topical haemostatic agent used in spinal surgery, by comparing it with Floseal (Baxter Healthcare, Deerfield, Illinois, USA). METHODS: We performed a randomized controlled trial in 78 patients who underwent spinal surgery. The participants were randomly assigned to either an intervention group (use of CollaStat) or a control group (use of Floseal). We compared successful haemostasis rate, time to hemostasis, length of hospital stay, amount of fluid drainage, and rate of adverse events between the 2 groups. RESULTS: The hemostasis success rate was 94.87% in the intervention group and 97.44% in the control group. The hemostatic efficacy and safety of CollaStat were found to be noninferior to those of Floseal since the higher limit (11.09%) of the confidence interval (CI) for the difference with Floseal was greater than the prespecified noninferiority margin of -13%. There were no statistically significant differences at the 5% level in hemostasis time, number of hemostatic agents used, hospitalization period, and amount of drainage between the 2 groups. Also, there was no incidence of medical device-related serious adverse events or adverse events in both groups. CONCLUSIONS: The hemostatic efficacy and safety of CollaStat were found to be noninferior to those of Floseal. Therefore CollaStat can be safely and effectively used in spinal surgery.

Factors Affecting Postoperative Complications and Outcomes of Cervical Spondylotic Myelopathy with Cerebral Palsy : A Retrospective Analysis.

OBJECTIVE: Cervical surgery in patients with cervical spondylotic myelopathy (CSM) and cerebral palsy (CP) is challenging owing to the complexities of the deformity. We assessed factors affecting postoperative complications and outcomes after CSM surgery in patients with CP. METHODS: Thirty-five consecutive patients with CP and CSM who underwent cervical operations between January 2006 and January 2014 were matched to 35 non-cerebral palsy (NCP) control patients. Postoperative complications and radiologic outcomes were compared between the groups. In the CP group, the Japanese Orthopaedic Association score; Oswestry neck disability index; modified Barthel index; and values for the grip and pinch, Box and Block, and Jebsen-Taylor hand function tests were obtained preand postoperatively and compared between those with and without postoperative complications. RESULTS: Sixteen patients (16/35%) in the CP group and seven (7/35%) in the NCP group (p=0.021) had postoperative complications. Adjacent segment degeneration (p=0.021), postoperative motor weakness (p=0.037), and revisions (p=0.003) were significantly more frequent in the CP group than in the NCP group; however, instrument-related complications were not significantly higher in the CP group (7/35 vs. 5/35, p=0.280). The number of preoperative fixed cervical deformities were significantly higher in CP with postoperative complications (5/16 vs. 1/19, p=0.037). In the CP group, clinical outcomes were almost similar between those with and without postoperative complications. CONCLUSION: The occurrence of complications during the follow-up period was high in patients with CP. However, postoperative complications did not significantly affect clinical outcomes.

Surgical Strategies for Cervical Deformities Associated With Neuromuscular Disorders.

Neuromuscular disorders (NMDs) are diseases involving the upper and lower motor neurons and muscles. In patients with NMDs, cervical spinal deformities are a very common issue; however, unlike thoracolumbar spinal deformities, few studies have investigated these disorders. The patients with NMDs have irregular spinal curvature caused by poor balance and poor coordination of their head, neck, and trunk. Particularly, cervical deformity occurs at younger age, and is known to show more rigid and severe curvature at high cervical levels. Muscular physiologic dynamic characteristics such as spasticity or dystonia combined with static structural factors such as curvature flexibility can result in deformity and often lead to traumatic spinal cord injury. In addition, postoperative complication rate is higher due to abnormal involuntary movement and muscle tone. Therefore, it is important to control abnormal involuntary movement perioperatively along with strong instrumentation for correction of deformity. Various methods such as botulinum toxin injection, physical therapy, muscle division technique, or intrathecal baclofen pump implant may help control abnormal involuntary movements and improve spinal stability. Surgical management for cervical deformities associated with NMDs requires a multidisciplinary effort and a customized strategy.