Transforaminal lumbar endoscopic discectomy: should we abandon it for L5-S1 foraminal and extraforaminal lumbar disc herniations? A prospective non-randomised study and literature review.

PURPOSE: The aim of this study is to investigate the clinical outcomes of transforaminal lumbar endoscopic discectomy (TLED) in patients with L5-S1 lumbar disc herniation (LDH). MATERIALS AND METHODS: Seventy-five consecutive individuals with diagnosed foraminal/extraforaminal L5-S1 LDH were included in this study. All patients underwent TLED, being subsequently evaluated in a 2-year follow-up period. Assessment was performed preoperatively and at 6 weeks and 3, 6, 12 and 24 months postoperatively. Visual Analogue Scale (distinctly applied for lower limb - VAS-LP and low back - VAS-BP pain) and Short-Form 36 (SF-36) Medical Health Survey Questionnaire were implemented to assess pain and health-related quality of life (HRQoL) of enrolled individuals, respectively. RESULTS: No major perioperative complications were observed. Recorded values of all studied indices were demonstrated to feature a clinically and statistically significant amelioration at 6 weeks, presenting lesser improvement at 3 months with subsequent stabilisation. VAS-LP and VAS-BP values were displayed to reach a plateau in 6 months postoperatively, whereas all parameters of SF-36 continued to present a statistically significant improvement until the end of follow-up at 2 years. CONCLUSIONS: TLED represent a safe and efficient technique in terms of diminishing perceived pain and improving HRQoL in patients with L5-S1 LDHs. However, specific patient- and technique-related circumstances on the ground of low surgical experience may limit its effectiveness in these patients.

Minimally invasive far lateral tubular microdiscectomy: surgical technique and case series of 176 patients.

BACKGROUND: Far lateral (extraforaminal) disc herniations comprise approximately 10% of symptomatic lumbar disc herniations. They represent operative challenges due to accessibility and surgical unfamiliarity. Surgical strategies in the past have included open discectomy and posterior lumbar interbody fusion. Tubular microdiscectomies have gained traction due to their minimally invasive advantages, including reduced morbidity, pain and length of hospital stay. METHODS: We report our retrospective single institution consecutive case series of tubular far lateral microdiscectomies. One hundred and seventy-six patients were operated on over an eight-year period. Clinical outcomes were assessed after institutional ethics approval. We additionally describe our surgical technique with an illustrative video case. RESULTS: Over a mean follow-up of 21 weeks, 77% of patients had good or excellent clinical outcomes according to the MacNab criteria. 12% of patients underwent reoperation at the index level for symptom recurrence or persistence. Mean length of hospital stay was 1.3 days. There was a 1% rate of both postoperative haematoma and infection. Mean operation duration was 86 minutes. CONCLUSION: This case series represents the largest currently reported in the literature. Minimally invasive microdiscectomies performed through tubes allow for precise localisation, reduced tissue disruption and favourable clinical outcomes. Our results appear consistent with a review of the literature, demonstrating the safety and efficacy of this approach.

Effect of Local Vibration Therapy on Pain, Joint Position Sense, Kinesiophobia, and Disability in Cervical Disc Herniation: A Randomized Controlled Trial.

Background/Objectives: Vibration therapy approaches are an effective and safe treatment option for musculoskeletal disorders. This study examines the effects of vibration therapy using a percussion massage gun (PMG) on joint position sense, range of motion, pain, functionality, and kinesiophobia in individuals with cervical disc herniation (CDH). Methods: This single-blind randomized controlled trial involved 44 CDH patients divided into a Vibration Group (VG) and a Conventional Group (CG). The CG underwent a standard physiotherapy treatment heat application, Transcutaneous Electrical Nerve Stimulation (TENS), and exercises for range of motion and strengthening. VG received conventional therapy augmented with vibration therapy (VT) via a PMG. Joint position sense (JPS) using the Laser Pointer Assisted Angle Repetition Test; pain intensity with the Visual Analog Scale, kinesiophobia with the Tampa Scale for Kinesiophobia, and cervical dysfunction with the Neck Disability Index were assessed. Results: Both groups showed statistically significant improvements in pain, kinesiophobia, disability, and proprioception after treatment (p < 0.05). When comparing the difference values between groups, the VG was found to be more effective than the CG in the parameters of VAS activity (p = 0.013). The CG had more improvement in JPS neck left rotation than the VG (p = 0.000). Conclusions: VT, when combined with conventional physiotherapy, is effective in improving pain, proprioception, and functionality in individuals with CDH. These findings support the inclusion of VT as a beneficial adjunct therapy. Further research with larger sample sizes and longer follow-ups is recommended to validate these results and explore the long-term effects of VT on CDH.

Postoperative Stroke Following Anterior Cervical Spine Surgery: A Case Report.

Vascular complications succeeding anterior cervical spine surgery are rare, but their consequences represent a major burden for the patient. Cerebral infarction following anterior cervical discectomy and fusion (ACDF) is uncommon. However, screening for risk factors before surgery should become mandatory. We present the case of a patient with no significant medical history who underwent ACDF for a C5/C6 herniated disc with myelopathy. Although the surgery was uneventful, after the surgery, partial right palpebral ptosis and miosis were noted, suggestive of Horner syndrome. On the fifth postoperative day, the patient experienced left hemiplegia and drowsiness. An emergency CT scan and cerebral MRI revealed ischemia in the right middle cerebral artery territory. The patient was transferred to a neurology center for mechanical thrombectomy, which revealed a complete occlusion of the right internal carotid artery. The procedure had to be halted due to blood extravasation at the internal carotid artery bifurcation to prevent further complications. An angio-CT examination of the cervical arteries exposed a soft atheromatous plaque on the right internal carotid artery, immediately after the bifurcation. Despite the patient having no significant medical history, blood tests indicated dyslipidemia. At the two-month follow-up, the patient remained hemiplegic, with mild dysphasia. Performing carotid and vertebral Doppler ultrasound before cervical spine surgery might be useful, whenever possible, to assess high-risk factors for ischemic events and avoid such debilitating complications.

Systematic Review and Critical Appraisal of Cauda Equina Syndrome Management During Pregnancy.

Cauda equina during pregnancy represents a rare entity, with data regarding optimal treatment being very scarce in the pertinent literature. Given the scarcity of current evidence on the topic, this study conducts a systematic review and analysis of existing literature concerning cauda equina syndrome (CES) management in pregnant women. A comprehensive search was performed across multiple databases, yielding 26 level IV peer-reviewed articles that met the inclusion criteria. These studies collectively encompassed 30 pregnant patients with CES, with a mean age of 31.2 years and an average gestational age of 26 weeks. Disc herniation emerged as the primary cause in 73% of cases. Regarding surgical interventions, the prone position was utilised in 70% of cases, with 73% receiving general anaesthesia. Notably, third-trimester spinal surgeries exhibited a higher complete recovery rate compared to earlier trimesters. Minimally invasive spinal surgery demonstrated superior outcomes in terms of complete recovery and reduced risk of persistent post-operative symptoms when compared to open approaches. Moreover, patients undergoing caesarean section (CS) after spinal surgery reported higher rates of symptom resolution and lower symptom persistence compared to those with CS before spinal surgery or vaginal delivery post-spinal surgery. Despite these study's findings, the overall evidence base remains limited, precluding definitive conclusions. Consequently, the study underscores the importance of multidisciplinary team discussions to formulate optimal treatment strategies for pregnant individuals presenting with CES. This highlights a critical need for further research to expand the knowledge base and improve the guidance available for managing CES in pregnant populations.

Minimal-invasive pain procedures are effective in different degenerative pain generators in CLBP: A prospective cohort study.

BACKGROUND: It is estimated that a significant number of spinal surgeries are performed, but many patients do not often benefit. OBJECTIVE: Our aim was to determine how effective minimally invasive pain procedures (MIP) are in chronic low back pain (CLBP) patients with proven degenerative causes (specific low back pain). METHODS: 386 eligible patients with CLBP/sciatica resistant to conservative therapy and scheduled for open surgery were screened, and 167 could be enrolled in this study. Indications for MIP in the remaining 150 individuals were made by one experienced spinal surgeon. Before and 6 months after the intervention, the numeric rating scale (NRS) and Oswestry Disability Index (ODI) were recorded. MIP was performed, such as radiofrequency of the facet and SI-joint, intradiscal electrothermal therapy in case of discogenic pain, as well as epidural neuroplasty in patients with disc herniation/epidural fibrosis. RESULTS: There was a statistically significant decrease in NRS (p< 0.05), as well as a significant increase in ODI (p< 0.001) 6 months after the procedures. This was also true for the results of all different pain generators and subsequent performed procedures alone. CONCLUSIONS: The indication of MIP should be routinely reviewed in patients with CLBP to avoid potentially open surgery and a burden on healthcare costs.

Symptomatic Subsidence of a Box-Shaped Titanium Cage After Anterior Cervical Discectomy and Fusion: Two Case Reports and Review of the Literature.

This study reports two cases of rare symptomatic subsidence of titanium cages after anterior cervical discectomy and fusion (ACDF). First, an 82-year-old man underwent ACDF at C5/6 and C6/7 using two 6 mm height box-type titanium cages. On the 34th postoperative day, motor weakness occurred in the right upper limb, and CT showed that the cage at C5/6 had subsided 6 mm into the C6 vertebral body. On postoperative day 55, both cages were removed, and C6 corpectomy was performed. The C5-7 space was refixed with a mesh cage and plate. He was discharged home from the rehabilitation hospital three months later. Second, a 41-year-old man underwent ACDF at C5/6 and C6/7 using two 5 mm height box-type titanium cages. He fell violently on the 33rd postoperative day, causing pain from the neck to the left hand, weakness, and skillful movement disorder in the left hand, and CT showed that the cages at C5/6 and C6/7 had subsided by 7 mm and 6 mm, respectively. On the 65th postoperative day, both cages were removed by reoperation, and C6 and 7 corpectomy was performed. The space between C5 and T1 was refixed with a mesh cage and plate. He was discharged home two months later. Possible causes of titanium cage subsidence include osteoporosis, trauma, vertebral cortex damage by an operative procedure, and cage height of 6 mm or more. While ACDF is safe and effective for cervical spondylosis, special caution is needed in older osteoporotic patients.

Full-endoscopic discectomy utilizing an interlaminar approach for gas-containing herniation at L5-S1.

Background: Intradiscal gas is frequently observed in older patients with disc degeneration and can occasionally result in nerve root compression. Case Description: A 79-year-old male patient presented with increasing left lower extremity sciatica. Lumbar computed tomography (CT) and magnetic resonance (MR) images revealed a left paramedian L5-S1 gas-containing disc herniation. Utilizing an interlaminar approach, a full-endoscopic discectomy (FED) was performed at L5-S1. During disc removal, we countered intradiscal gas bubbles. Postoperatively, the patient's symptoms/signs fully resolved, and follow-up MR and CT images revealed total resection of the disc herniation, and no further gas. Conclusion: Through an interlaminar FED, we effectively removed an L5-S1 MR/CT-documented gas-containing disc herniation.

Identification of copper death-associated molecular clusters and immunological profiles for lumbar disc herniation based on the machine learning.

Lumbar disc herniation (LDH) is a common clinical spinal disorder, yet its etiology remains unclear. We aimed to explore the role of cuproptosis-related genes (CRGs) and identify potential diagnostic biomarkers. Our analysis involved interrogating the GSE124272 and GSE150408 datasets for differential gene expression profiles associated with CRGs and immune characteristics. Molecular clustering was performed on LDH samples, followed by expression and immune infiltration analyses. Using the WGCNA algorithm, specific genes within CRG clusters were identified. After selecting the most predictive genes from the optimal model, four machine learning models were constructed and validated. This study identified nine CRGs associated with copper-regulated cell death. Two copper-containing molecular clusters linked to death were detected in LDH samples. Elevated expression and immune infiltration levels were found in LDH patients, particularly in CRG cluster C2. Utilizing XGB, five genes were identified for constructing a diagnostic model, achieving an area under the curve values of 0.715. In conclusion, this research provides valuable insights into the association between LDH and copper-regulated cell death, alongside proposing a promising predictive model.

Prediction of transforaminal epidural injection success in sciatica (POTEISS): a protocol for the development of a multivariable prediction model for outcome after transforaminal epidural steroid injection in patients with lumbar radicular pain due to disc herniation or stenosis.

BACKGROUND: Transforaminal epidural injections (TEI) can alleviate symptoms and help to maintain physical functioning and quality of life in patients with lumbar radicular pain. We aim to develop a prediction model for patient outcome after TEI in patients suffering from unilateral lumbar radicular pain due to lumbar disc herniation (LDH) or single-level spinal stenosis (LSS). The secondary aim is to estimate short-term patient outcome differences between LDH and LSS patients, the association between psychological variables and patient outcome, the rate of additional injections, surgery and complications, and to explore the short-term cost-effectiveness of TEI. METHODS: This study is designed as a multi-centre, observational, prospective cohort study in two large regional hospitals in the Netherlands. Patients diagnosed with unilateral lumbar radicular pain secondary to LDH or LSS and congruent with MRI findings, who are referred for TEI along usual care pathways, are eligible for study participation. A total of 388 patients with LDH or LSS will be included. A pre-defined set of demographic, clinical and radiological variables will be used as the predictors in the model. The primary outcome measure is the Numerical Rating Scale (NRS) for leg pain. Secondary outcome measures include back pain, physical functioning, perceived recovery, pain coping strategies, anxiety and depression and use of analgesics and physical therapy. Patients will be evaluated at baseline, 2 weeks and 6 weeks after treatment. NRS leg pain and Likert perceived recovery data will be used as the dependent variables in a generalized linear mixed model for prediction of TEI outcome, with internal validation of performance (explained variation) by bootstrap resampling. Cost-effectiveness for a period of 6 weeks prior to and after treatment will be performed with decision-analytic modelling. DISCUSSION: Patients with severe lumbar radicular pain often request additional treatment when conservative care is insufficient. TEI can offer relief of symptoms. Currently, it is not possible to predict responsiveness to this treatment for individual patients. This study is designed to explore predictors that can differentiate between patients that will and will not have a positive outcome after TEI. This information may support treatment strategies for this patient group. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov database under registry number NCT04540068 on September 1, 2020.

[Surgical treatment of recurrent herniated discs of the lumbar spine depending on risk factors]. / Vybor taktiki khirurgicheskogo lecheniya retsidivov gryzh diskov poyasnichnogo otdela pozvonochnika na osnovanii analiza faktorov riska ikh razvitiya.

According to the literature, recurrent disc herniation of the lumbar spine occurs in 5-10% of cases. Objective. To develop an algorithm for surgical treatment of recurrent lumbar spine disc herniation based on analysis of risk factors of relapse and assessment of intra- and postoperative period. MATERIAL AND METHODS: The study included 61 patients with recurrent intervertebral disc herniation. Thirty patients underwent repeated microdiscectomy without transpedicular fixation, 31 patients - resection of recurrent disc herniation with transpedicular fixation (PLIF technique). The control group included 63 patients without recurrent disc herniation. Mean follow-up period was 3.5 years. RESULTS: Discectomy with transpedicular fixation is characterized by larger extent, prolonged surgery time and rehabilitation period. However, there is lower risk of recurrent disc herniation and CSF leakage. Repeated microdisectomy without transpedicular fixation is characterized by smaller extent and shorter surgery time, as well as faster recovery period. Nevertheless, we have higher risk of recurrent disc herniation and CSF leakage. We developed a method for assessing the probability of recurrent intervertebral disc herniation. This algorithm allows us to predict the probability of recurrent disc herniation in a particular patient with 86.7% accuracy. CONCLUSION: We proposed an algorithm for choosing surgical treatment of recurrent disc herniation. Microdiscectomy without fixation is advisable for the risk of recurrent disc herniation <30%, discectomy with transpedicular fixation - for risk of disc herniation >30%.

[Orthopedic robot-assisted endoscopic transforaminal lumbar interbody fusion for lumbar disc herniation with lumbar instability].

OBJECTIVE: To explore the safety and effectiveness of the robot-assisted system for transforaminal percutaneous endoscopic in the treatment of lumbar disc herniation with lumbar instability. METHODS: From October 2021 to March 2023, 26 patients with single-segment lumbar disc herniation and lumbar spinal instability were treated with robot-assisted system for transforaminal percutaneous endoscopic. The operation time, intraoperative blood loss, incision length, postoperative drainage volume, postoperative ambulation activity time, postoperative hospitalization time were record. The intervertebral space height and the lumbar lordosis angle before and after surgery were observed and compared. Pain level was evaluated using the visual analogue scale(VAS). The clinical efficacy was evaluated by Oswestry disability index(ODI). The interbody fusion was evaluated by Brantigan Steffee criteria. RESULTS: All patients successfully completed the operation, the operation time ranged form 105 to 109 min with an average of (150.8±24.1) min. Intraoperative blood loss ranged form 35 to 88 ml with an average of (55.5±16.4) ml. Incision length ranged form 1.4 to 3.5 cm with an average of (2.3±0.8) cm. Postoperative drainage volume ranged form 15 to 40 ml with an average of (28.5±7.8) ml. Postoperative ambulation time ranged form 15 to 30 h with an average of (22.8±4.5) h. Postoperative hospitalization time was 3 to 7 d with an average of (4.2±1.3) d. Total of 26 patients were followed up, the duration ranged from 12 to 16 months with an average of (14.0±1.3) months. The VAS and ODI at 1 week [(2.96±0.72) points, (41.63±4.79)%] and 12 months[(1.27±0.60) points, (13.11±2.45)%] were significantly different from those before surgery[(6.69±0.93) points, (59.12±5.92)%], P<0.01. The height of the intervertebral space (11.95±1.47) mm and lumbar lordosis (57.46±7.59)° at 12 months were significantly different from those before surgery [(6.67±1.20) mm, (44.08±7.79)°], P<0.01. At 12 months after surgery, all patients had no pedicle screw rupture or dislocation of the fusion cage, and the intervertebral fusion was successful. According to Brantigan-Steffee classification, 17 cases were grade D and 9 cases were grade E. CONCLUSION: Robot-assisted system for transforaminal percutaneous endoscopic for the treatment of single-segment lumbar disc herniation with lumbar instability improved the accuracy and safety of the operation, and the clinical effect of early follow-up is accurate.

The Impact of Demographic Characteristics, Obesity, Surgical Level, and Intervertebral Disc Properties on Recurrence of Lumbar Disc Herniation.

BACKGROUND: This study focused on identifying factors influencing recurrent lumbar disc herniation (RLDH) by analyzing demographic data, body mass index (BMI), and radiologic disc properties in patients undergoing single-level unilateral lumbar disc herniation surgery. METHODS: Our retrospective analysis included 2 groups from our clinic: Group 1 (n = 41) with patients experiencing RLDH requiring a second surgery, and Group 2 (n = 73) with patients having a single surgery and no recurrence over at least a 5-year follow-up. We assessed age, sex, diabetes mellitus (DM), hypertension (HT), BMI, Pfirrmann disc degeneration type, herniation types (protrusion, extrusion, and sequestration), and surgical level. RESULTS: The mean ages of Groups 1 and 2 were 48.93 ± 13.47 and 44.4 ± 11.79 years, respectively, with no significant age difference (P = 0.064). Gender distribution was also not significantly different, with 63.41% males in Group 1 and 56.16% in Group 2 (P = 0.450). DM prevalence was similar in both groups (P = 0.727). Notably, HT was significantly lower in Group 2 (P = 0.018). The average BMI was comparable between groups (P = 0.607), and no significant difference in Pfirrmann disc degeneration scores was observed (P = 0.547). Radiologic disc type distributions did not significantly differ (P = 0.448). Most surgeries in both groups were at the L4-5 level, with no significant differences in surgical levels (P = 0.456). CONCLUSIONS: We found that factors like gender, age, DM, obesity, surgical level, disc degeneration, and disc types do not significantly impact RLDH. However, the higher occurrence of HT in recurrent cases indicates a potential area for further research.

Posterior biportal endoscopic discectomy for the treatment of central cervical disc herniation: technical note and preliminary results.

OBJECTIVE: To evaluate the preliminary outcomes and clinical efficacy of a novel posterior biportal endoscopic technique in the treatment of CCDH. METHOD: A total of eleven patients with symptomatic CCDH who met the inclusion criteria underwent posterior biportal endoscopic discectomy between December 2021 and May 2023. The surgical procedure involved flavectomy, foraminotomy, pediculoplasty, and discectomy using 30° and 45° arthroscopes and specialised minimally invasive tools. Functional outcomes were assessed using the Japanese Orthopedic Association (JOA) scoring system, Neck Disability Index (NDI), and visual analogue scale (VAS) for axial neck pain. Clinical efficacy was evaluated at the final follow-up using the modified Macnab criteria. RESULTS: All eleven patients successfully underwent posterior biportal endoscopic discectomy with a mean operative time of 82.7±10.1 minutes and mean estimated blood loss of 31.8±9.8 ml. The mean hospital stay was 5.2±1.1 days, and the mean follow-up period was 13.8±2.4 months. Significant improvements were observed in NDI, JOA and VAS scores. Clinical efficacy was rated as excellent in three patients, good in six patients, and fair in two patients according to the modified Macnab criteria. No cases of cervical instability or kyphosis were observed during postoperative follow-up. CONCLUSION: The novel posterior biportal endoscopic technique demonstrated significant clinical efficacy and safety in treating CCDH, with marked improvements in clinical outcomes, rapid postoperative recovery, and a low incidence of complications.

Usefulness and Safety of Gelatin-Thrombin Matrix Sealants in Minimally Invasive Microscopic Discectomy.

Objective This study aimed to evaluate the usefulness and safety of gelatin-thrombin matrix sealants (GTMSs) in minimally invasive microscopic discectomy, a surgical procedure commonly used to treat lumbar disc herniation. Materials and Methods Out of 484 patients who underwent minimally invasive microscopic discectomy between April 2018 and December 2022, 35 patients with a history of surgery at the same level were excluded, resulting in a total of 449 patients included in the study. Among them, 316 patients were treated using GTMS, whereas 133 were treated using collagen-based absorbable local hemostatic agents. Patient characteristics, surgical duration, intraoperative blood loss, postoperative drainage volume, intraoperative dural injury, and incidence of postoperative epidural hematoma were analyzed and compared between the two groups. Results No significant differences in patient demographics were observed between the two groups, except for activated partial thromboplastin time and prothrombin time. Although there were no significant differences in the mean surgical time and intraoperative blood loss between the two groups, they tended to be shorter and less in the GTMS group (56.3 ± 20.2 vs. 58.2 ± 20.4 minutes [ p = 0.36] and 10.0 ± 15.4 vs. 11.8 ± 8.3 g [ p = 0.20]). The volume of postoperative drainage was significantly lower in the GTMS group than that in the comparison group (35.3 ± 21.8 vs. 49.5 ± 34.1 g [ p < 0.01]). There was a trend indicating a difference in the number of intraoperative dural injuries and the need for reoperation due to postoperative epidural hematoma (2 vs. 3 ± 20.4 minutes [ p = 0.21] and 1 vs. 2 [ p = 0.16]). Conclusion The use of a GTMS in minimally invasive microscopic discectomy appears to be beneficial in reducing postoperative drainage volume. It has also been shown that it may improve clinical outcomes such as intraoperative dural injury and postoperative epidural hematoma. Furthermore, further consideration of the medical economic impact is required.

Clinical outcomes of fenestration discectomy and iLESSYS-Delta interlaminar endoscopic system for treatment of LDH: a single-center retrospective cohort study.

To compare the clinical efficacy of interlaminar endoscopic surgical system delta (iLESSYS-Delta) discectomy with that of classical fenestration discectomy for treating lumbar disc herniation. Patients who underwent iLESSYS-Delta or fenestration discectomy were enrolled in this study. Baseline information and clinical indicators were collected. The baseline data were matched using propensity score matching. Fifty-two patients were in each group. In the iLESSYS-Delta cohort, the volume of intraoperative bleeding was 18.17 ± 4.20 ml, the length of postoperative hospital stay was 4.16 ± 2.29 days, and the length of postoperative off-bed activity was 1.58 ± 0.88 days. In contrast, in the fenestration group, the volume of intraoperative bleeding was 32.50 ± 17.13 ml, the length of postoperative hospital stay was 6.66 ± 2.44 days, and the length of postoperative off-bed activity was 3.18 ± 1.28 days. The difference between the two groups was statistically significant (P < 0.05). The operation time was 88.90 ± 19.14 min in the iLESSYS-Delta group and 67.63 ± 19.32 min in the fenestration group, and the difference between the two groups was statistically significant (P < 0.05). Regarding the pain visual analogue scale scores at 24, 48, and 72 h after surgery, patients in the iLESSYS-Delta group had less pain than did those in the fenestration group (P < 0.05). The Oswestry disability indices of postoperative patients in both groups significantly improved at 3 months after surgery and at the last follow-up (P < 0.05); however, there was no statistically significant difference in the postoperative ODI scores between the two surgery groups (P > 0.05). The two groups showed no significant differences in clinical effects, postoperative recurrence rates, or perioperative complications. iLESSYS-Delta can cause less intraoperative bleeding and faster recovery than fenestration discectomy.

The effect of human assumed central sensitization on transforaminal epidural steroid injection in chronic lumbar radiculopathy: An observational study.

BACKGROUND: Human assumed central sensitization (HACS) is a potential pathophysiological mechanism underlying a group of musculoskeletal disorders. HACS may negatively influence the outcomes of surgical or interventional procedures. OBJECTIVE: The present study aimed to investigate the impact of HACS on treatment outcomes of transforaminal epidural steroid injection (TFESI). METHODS: Patients who received fluoroscopy-guided single-level lumbosacral TFESI between January 2020 and January 2021 were included in the study. The patients were divided into two groups with respect to the existence of HACS. Patients were assessed before the procedure, at the third week, and at the third month after the procedure. The presence of HACS was investigated by central sensitization inventory (CSI). The Numerical Rating Scale (NRS), Oswestry Disability Index (ODI), and Beck Depression Inventory (BDI) were used for patient assessment. RESULTS: A total of 65 patients were included in the study. Thirty-one of the patients had HACS. There was no difference between the groups in terms of demographic data. Significant improvement in NRS was found at 3rd week and 3rd month compared to the baseline. BDI and ODI scores were also significantly reduced at the end of 3 months (p< 0.001). NRS scores at all time points were significantly lower in patients without HACS (p< 0.05). CONCLUSION: The presence of HACS has a negative effect on pain scores, disability, and mental state in patients undergoing TFESI.

A phase 3, randomized, double-blind, sham-controlled trial of SI-6603 (condoliase) in patients with radicular leg pain associated with lumbar disc herniation.

BACKGROUND CONTEXT: SI-6603 (condoliase) is a chemonucleolytic agent approved in Japan in 2018 for the treatment of lumbar disc herniation (LDH) associated with radicular leg pain. Condoliase, a mucopolysaccharidase with high substrate specificity for glycosaminoglycans (GAGs), offers a unique mechanism of action through the degradation of GAGs in the nucleus pulposus. As LDH management is currently limited to conservative approaches and surgical intervention, condoliase could offer a less invasive treatment option than surgery for patients with LDH. PURPOSE: The Discover 6603 study (NCT03607838) evaluated the efficacy and safety of a single-dose injection of SI-6603 (condoliase) vs sham for the treatment of radicular leg pain associated with LDH. STUDY DESIGN/SETTING: A randomized, double-blind, sham-controlled, phase 3 study conducted across 41 sites in the United States. PATIENT SAMPLE: Male and female participants (N=352; aged 30-70 years) with contained posterolateral LDH and unilateral radiculopathy/radicular leg pain for greater than 6 weeks. OUTCOME MEASURES: The primary endpoint was the change from baseline (CFB) in average worst leg pain score at 13 weeks, assessed using the 100-mm visual analogue scale. Key secondary endpoints were CFB in average worst leg pain score at 52 weeks, herniation volume at 13 weeks, and Oswestry Disability Index (ODI) score at 13 weeks. Safety evaluations included adverse events (AEs) and imaging findings. METHODS: Participants were randomized 1:1 to receive a single intradiscal injection of condoliase (1.25 units) or sham injection followed by 52 weeks of observation. The primary and key secondary endpoints were assessed using a mixed model for repeated measures (MMRM) analysis and a protocol-specified multiple imputation (MI) sensitivity analysis on the modified intention-to-treat (mITT) population. A prespecified serial gatekeeping algorithm was used for multiple comparisons. Safety endpoints included AEs, laboratory tests, vital signs, imaging (by X-ray and magnetic resonance imaging [MRI]), and occurrence of posttreatment lumbar surgery. RESULTS: Of the 352 randomized participants, 341 constituted the mITT population (condoliase n=169; sham n=172) and the safety population (condoliase n=167; sham n=174). For the primary endpoint, the condoliase group showed significantly greater improvement in CFB in worst leg pain at Week 13 (least squares mean [LSM] CFB: -41.7) compared with sham injection (-34.2; LSM difference: -7.5; 95% confidence interval [CI]: -14.1, -0.9; p=.0263) based on the MMRM analysis. CFB in worst leg pain at Week 52 favored condoliase vs sham, but the difference was not statistically significant (p=.0558), which halted the serial gatekeeping testing algorithm and dictated that the CFB in herniation volume and ODI scores at Week 13 would be considered nonsignificant, regardless of their p-values. Treatment group differences in CFB in herniation volume and ODI score favored the condoliase group vs sham at all timepoints. The MI sensitivity analysis showed differences in CFB in worst leg pain at Week 13 (p=.0223) and Week 52 (p=.0433) in favor of the condoliase group. Treatment-emergent AEs (TEAEs) were more common in the condoliase group (≥1 TEAE: 71.9%; ≥1 treatment-related TEAE: 28.1%) compared with the sham group (≥1 TEAE: 60.3%; ≥1 treatment-related TEAE: 10.3%). Of the TEAEs, spinal MRI abnormalities and back pain occurred most frequently. No treatment-related serious AEs occurred. CONCLUSIONS: Condoliase met its primary endpoint of significantly improving radicular leg pain at Week 13 and was generally well tolerated in patients with LDH. Chemonucleolysis with condoliase has the potential to provide a less invasive treatment option than surgery for those unresponsive to conservative treatment strategies.

Indication and Limitation of Intradiscal Condoliase Injection for Patients with Lumbar Disc Herniation: Literature Review and Meta-Analysis.

Background: Intradiscal condoliase injection for lumbar disc herniation (LDH) was developed in Japan in 2018. The treatment is intermediate between conservative therapy and surgery, and its frequency is increasing. Condoliase is limited to a single application over a lifetime, rendering it important to understand the indications and predictors of its effectiveness. This review aimed to summarize published studies and provide appropriate indications and limitations for appropriate patient selection based on existing findings. Methods: While adhering to PRISMA guidelines, we searched the PubMed, Web of Science, and EMBASE databases to identify articles reporting the clinical outcomes of intradiscal condoliase injection for LDH. Data extraction focused on the effective rate, prognostic factors, and posttreatment imaging changes and was used in the meta-analysis. Results: Nineteen studies met the inclusion criteria. Our meta-analysis revealed 78% total response, 11% posttreatment surgery, and 42% posttreatment Pfirrmann-classification-grade progression rates. Posttreatment intervertebral disc degeneration was potentially associated with an improved response rate and disc regeneration one year posttreatment, especially in young patients. The Regimen for patients aged <20 and >70 years should be carefully selected, including those with a disease duration of >1 year, recurrent LDH, small-sized LDH, vertebral instability, and inadequate duration (<3 months) of conservative therapy. Conclusions: Although long-term outcomes and imaging changes must be evaluated owing to the heterogeneity of previous studies, intradiscal condoliase injection is a minimally invasive and cost-effective treatment option for patients with LDH. Treatment indications should be determined after carefully evaluating evidence from previous conservative and surgical treatments.

Patient-Reported Outcomes and Patient Satisfaction Following Surgery for Thoracic Myelopathy.

Introduction: The association between postoperative patient-reported outcomes (PROs) and patient satisfaction remains poorly defined in patients undergoing surgery for thoracic myelopathy. This study aimed to investigate PROs and patient satisfaction following surgical intervention for thoracic myelopathy. Methods: A prospective cohort of 133 patients who underwent surgery for thoracic myelopathy at 13 hospitals between April 2017 and August 2021 was enrolled. Patient demographics and perioperative complications were recorded. PROs were assessed using questionnaires administered preoperatively and 1 year postoperatively, including the EuroQol-5 dimension, physical and mental component summaries of the 12-item Short-Form Health Survey, Oswestry Disability Index, and numerical rating scales for low back, lower extremity, and plantar pain. Patients were categorized into two groups: satisfied (very satisfied, satisfied, and slightly satisfied) and dissatisfied (neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied, and very dissatisfied). Results: The mean age of the patients was 66.5 years, comprising 87 men and 46 women. The most common diagnoses were ossification of the ligamentum flavum (48.8%) and thoracic spondylotic myelopathy (26.3%). Seventy-four (55.6%) and 59 (44.3%) patients underwent decompression surgery and underwent decompression with fusion, respectively. Eight patients required reoperation due to postoperative surgical site infection, hematoma, and insufficient decompression in four, three, and one patient. Ninety (67.7%) patients completed both the preoperative and postoperative PRO questionnaires, all of which demonstrated significant improvement. Among them, 58 (64.4%) and 32 (35.6%) reported satisfaction and dissatisfaction with their treatment, respectively. The satisfied group showed superior improvement in PROs than the dissatisfied group, although there were no significant differences in complication rates between the two groups. Conclusions: The 64.4% satisfaction rate observed in patients undergoing surgery for thoracic myelopathy was lower than that reported in previous studies on cervical or lumbar spine surgery. The dissatisfied group exhibited significantly poorer quality of life (QOL) and higher pain scores than the satisfied group.