Full-Endoscopic Foraminal Decompression for Foraminal Stenosis Following Osteoporotic Vertebral Fracture in an Elderly Woman Under Local Anesthesia:A Case Report.

Osteoporotic vertebral fracture (OVF) is common in the elderly population. In this report, we describe a case with radiculopathy due to foraminal stenosis caused by OVF in a very elderly patient that was treated successfully by full-endoscopic foraminotomy under local anesthesia. The patient was an 89-year-old woman who presented with a chief complaint of left leg pain for 5 years. She visited a couple of hospitals and finally consulted us to determine the exact cause of the pain. Computed tomography scans were obtained and selective nerve root block at L3 was performed. The diagnosis was radiculopathy at L3 due to foraminal stenosis following OVF. The patient had severe heart disease, so we decided to avoid surgery under general anesthesia and planned full-endoscopic spine surgery under local anesthesia. We performed transforaminal full-endoscopic lumbar foraminotomy at L3-L4 to decompress the L3 nerve root. The leg pain disappeared completely immediately after surgery. Postoperative computed tomography confirmed appropriate bone resection. The leg pain did not recur during a year of postoperative follow-up. OVF may cause lumbar radiculopathy as a result of foraminal stenosis, and transforaminal full-endoscopic lumbar foraminotomy under local anesthesia would be the best option in an elderly patient with poor general condition. J. Med. Invest. 71 : 179-183, February, 2024.

Surgical management of lower limb radiculopathy following acute singe-level osteoporotic vertebral fracture of lower lumbar spine in geriatric patient: a retrospective study.

BACKGROUND: Radiculopathy of the lower limb after acute osteoporotic vertebral fractures (OVFs) in the lower lumbar spine is uncommon in geriatric patients. Moreover, surgical intervention is generally recommended in patients who are irresponsive to conservative treatment. Determining an optimum surgical strategy is challenging considering the poor general condition of this population. Thus, herein, we established an algorithm for surgically managing this clinical scenario, hoping to provide a reference for making a surgical decision. METHODS: We retrospectively studied patients who suffered from new-onset radiculopathy of the lower limb after acute single-level OVFs in the lower lumbar spine and eventually underwent surgical intervention at our department. Information on the demographics, bone quality, AO spine classification of the vertebral fracture, pre-existing degenerative changes, including foraminal stenosis and lumbar disc herniation, and surgical intervention type was collected. Additionally, clinical outcomes, including preoperative and postoperative visual analog scale (VAS) scores for back and leg pain, Oswestry disability index (ODI), and MacNab criterion for response to surgery, were evaluated. RESULTS: From September 2019 to December 2021, a total of 22 patients with a mean age of 68.59 ± 9.74 years were analyzed. The most involved vertebra was L5 (54.5%), followed by L4 (27.3%) and L3 (18.2%). Among the 22 patients, 15 (68.2%) were diagnosed with the A1 type fracture of AO classification, and among them, 11 (73.3%) were characterized by the collapse of the inferior end plate (IEP). Three patients (13.6%) suffered from A2-type fractures, whereas four patients (18.2%) suffered from A3-type fractures. Pre-existing degenerative changes were observed in 12 patients (54.5%) of the patients. A total of 16 patients (72.7%) were treated by percutaneous kyphoplasty (PKP). Additionally, three patients underwent posterior instrumentation and fusion, two patients underwent a secondary endoscopic foraminoplasty, and one patient underwent a secondary radiofrequency ablation. The mean follow-up period was 17.42 ± 9.62 months. The mean VAS scores for leg and back pain and ODI decreased significantly after the surgery (P < 0.05). The total satisfaction rate at the last follow-up was 90.9% per the Macnab criterion. CONCLUSION: Patients with OVFs in the IEP are predisposed to suffer from radiculopathy of the lower limb. PKP alone or in combination with other minimally invasive surgical strategies is safe and effective in treating stable fractures. Additionally, aggressive surgical intervention should be considered in patients with unstable fractures or severe foraminal encroachment.

Basivertebral nerve ablation with concurrent lumbar laminotomy.

Lumbar radiculopathy due to impingement of nerve roots from facet hypertrophy and/or disc herniation can often coincide with vertebrogenic low back pain. This is demonstrated on MRI with foraminal stenosis and Modic changes. We examine the potential of using a combination of basivertebral nerve ablation (BVNA) and lumbar laminotomy as an alternative to traditional spinal fusion in specific patient populations. This unique combination of surgical techniques has not been previously reported in the medical literature. We report a man in his late 30s with chronic low back pain and lumbar radiculopathy, treated with BVNA and concurrent laminotomy. The patient reported progressive improvements in his mobility and pain over the next 2 years. We discuss the advantages of using this technique for lumbar radiculopathy and Modic changes compared with conventional surgical modalities.

Posterior Lateral Endoscopic Cervical Discectomy Through a Lateral Mass Approach in the Treatment of Cervical Spondylotic Radiculopathy.

OBJECTIVE: The present study outlines the feasibility, safety, and short-term clinical outcomes of posterior lateral endoscopic cervical discectomy (PLECD) through a lateral mass approach for treating cervical spondylotic radiculopathy (CSR). METHODS: This single-center retrospective observational study involved 30 patients with single-level CSR who had failed conservative treatment and presented with clinical symptoms consistent with imaging findings undergoing PLECD via a lateral mass approach. Primary outcomes included the visual analog scale (VAS) for neck and arm pain, the Japanese Orthopedic Association (JOA) score, and the modified MacNab criteria. Radiographic follow-up consisted of static and dynamic cervical radiographs and computed tomographic scans. RESULTS: Thirty patients (13 men and 17 women; mean age 48.8 ± 11.9 years) underwent this procedure, and the mean operative time was 74.90 ± 13.52 minutes. Mean follow-up was 7.37 ± 2.17 months. The VAS scores for the neck and arm decreased significantly at the last follow-up (neck, 26.80 ± 4.75 to 9.87 ± 1.78; arm, 71.30 ± 8.48 to 14.73 ± 4.00) (P < 0.05). The JOA score also decreased from 13.47 ± 1.36 to 15.90 ± 0.92 at the last follow-up (P < 0.05). Twenty-nine patients demonstrated satisfactory outcomes based on the modified MacNab criteria at the last follow-up. All patients exhibited a positive clinical response, experiencing relief from symptoms. Postoperative computed tomography (CT) scans confirmed the complete removal of lesions. CONCLUSIONS: PLECD through a lateral mass approach, as an alternative to conventional "keyhole" approaches, proves to be a novel and viable therapeutic option for CSR, demonstrating both high efficacy and safety.

Confirmatory study of the usefulness of quantum molecular resonance and microdissectomy for the treatment of lumbar radiculopathy in a prospective cohort at 6 months follow-up.

OBJECTIVES: Low back pain is a common musculoskeletal complaint and while prognosis is usually favorable, some patients experience persistent pain despite conservative treatment and invasive treatment to target the root cause of the pain may be necessary. The aim of this study is to evaluate patient outcomes after treatment of lumbar radiculopathy (LR) with quantum molecular resonance radiofrequency coblation disc decompression and percutaneous microdiscectomy with grasper forceps (QMRG). METHODS: This prospective cohort study was carried out in two Spanish hospitals on 58 patients with LR secondary to a contained hydrated lumbar disc hernia or lumbar disc protrusion of more than 6 months of evolution, which persisted despite conservative treatment with analgesia, rehabilitation, and physiotherapy, and/or epidural block, in the previous 2 years. Patients were treated with QMRG and the outcomes were measured mainly using the Douleur Neuropathique en 4 Questions, Numeric Rating Scale, Oswestry Disability Index, SF12: Short Form 12 Health Survey, Patient Global Impression of Improvement, Clinical Global Impression of Improvement, and Medical Outcomes Study Sleep Scale. RESULTS: Patients who received QMRG showed significant improvement in their baseline scores at 6 months post-treatment. The minimal clinically important difference (MCID) threshold was met by 26-98% of patients, depending on the outcome measure, for non-sleep-related outcomes, and between 17 and 62% for sleep-related outcome measures. Of the 14 outcome measures studied, at least 50% of the patients met the MCID threshold in 8 of them. CONCLUSION: Treatment of LR with QMRG appears to be effective at 6 months post-intervention.

Cervical Nerve Root Block Using a Curved Blunt Needle and Posterior Approach.

BACKGROUND: Cervical transforaminal epidural steroid injections have become less popular due to the risk of catastrophic complications they pose. However, cervical nerve root blocks are useful for surgical planning in patients with cervical radicular pain syndromes. OBJECTIVES: Our aim was to find a method of performing cervical selective nerve root blocks that removed the risk of catastrophic complications. STUDY DESIGN: Retrospective case review. SETTING: Academic multidisciplinary spine center. METHODS: Among patients, 50 consecutive cases were retrospectively reviewed for immediate pain scores and follow-up results. In the intervention, a posterior approach using a curved blunt needle was employed for cervical selective nerve root blocks to minimize the risk of arterial injection. To measure the outcomes, we used quantitative pain severity scores and qualitative responses. RESULTS: This technique detailed in this study has a high immediate analgesic effect that can be used for diagnostic purposes. It is not known if this technique has prognostic value with respect to surgery. The prolonged response rate is about 50%, which is in line with other techniques. LIMITATIONS: This study had no control group. CONCLUSION(S): Cervical selective nerve root blocks using a curved blunt needle and a posterior approach are effective in selectively identifying nerves that cause clinical symptoms. This technique minimizes the risk of arterial or spinal cord impingement and therefore may be safer than transforaminal selective nerve root blocks.

Ultrasound-guided versus fluoroscopy-guided lumbar selective nerve root block: a retrospective comparative study.

The purpose of this study is to compare the accuracy and effectiveness of ultrasound-guided and fluoroscopy-guided lumbar selective nerve root block (SNRB), and to explore the feasibility of ultrasound-guided methods. This retrospective study included patients with lumbar radicular pain who underwent ultrasound-guided and fluoroscopy-guided selective nerve root block at Honghui Hospital Affiliated to Xi'an Jiaotong University from August 2020 to August 2022. Patients were divided into U-SNRB group and F-SNRB group according to ultrasound-guided or fluoroscopy-guided selective nerve root block. There were 43 patients in U-SNRB group and 20 patients in F-SNRB group. The pain visual analogue scale (VAS) scores, Japanese Orthopaedic Association (JOA) scores, related indexes and complications were recorded and compared between the two groups before, 30 min, 1 month and 6 months after block. To evaluate the feasibility, accuracy and effectiveness of ultrasound-guided selective nerve root block. There were no complications in the process of selective nerve root block in both groups. The operating time and the times of closing needle angle adjustment in U-SNRB group were better than those in F-SNRB group, and the difference was statistically significant (P < 0.05). The VAS score and JOA score of patients in the two groups were significantly improved 30 min after block, 1 month and 6 months after block, and the difference was statistically significant (P < 0.05). There was no significant difference between the two groups (P > 0.05). The accuracy of ultrasound-guided selective nerve root block and the degree of pain relief of patients were similar to those of fluoroscopy guidance, but the operation time and needle angle adjustment times were significantly less than that of fluoroscopy, and could effectively reduce radiation exposure. Therefore, it can be used as a better way to guide for choice.

[Influence of preoperative symptom duration on effectiveness of cervical disc arthroplasty in cervical spondylotic radiculopathy patients].

Objective: To investigate the influence of preoperative symptom duration on effectiveness of cervical disc arthroplasty (CDA) in cervical spondylotic radiculopathy (CSR) patients. Methods: The clinical data of 90 CSR patients who underwent single-segment CDA between January 2008 and March 2020 and met the selection criteria were retrospectively analyzed. Based on preoperative symptom duration, patients were divided into an early intervention group (preoperative symptom duration <24 months) and a late intervention group (preoperative symptom duration ≥24 months). There was no significant difference in baseline data between the two groups ( P>0.05), including age, gender, body mass index, smoking status, surgical segment, preoperative neck disability index (NDI), visual analogue scale (VAS) score, cervical lordosis (CL), C 2-C 7 range of motion (ROM), disc angle (DA), disc ROM (DROM), and disc intervertebral height (DIH). The early intervention group had a slightly higher preoperative Japan Orthopedic Association (JOA) score than the late intervention group ( P<0.05). Perioperative indicators such as operation time, intraoperative blood loss, and postoperative hospital stay were recorded. The changes of JOA score, NDI, and VAS score at last follow-up compared with those before operation were used to evaluate the clinical efficacy, and the imaging evaluation of CL, C 2-C 7 ROM, DA, DROM, and DIH was performed before operation, immediately after operation, and at last follow-up. The incidence of prosthesis-related complications, including heterotopic ossification (HO), anterior bone loss (ABL), and prosthesis subsidence, was also assessed at last follow-up. Results: Patients in both groups were followed up 24-120 months, with an average of 53.4 months. There was no significant difference in operation time, intraoperative blood loss, or follow-up duration between the groups ( P>0.05). However, the late intervention group had significantly longer postoperative hospital stay compared to the early intervention group ( P<0.05). At last follow-up, there was no significant difference in the changes of JOA score, NDI, and VAS score between the two groups before and after operation ( P>0.05). During the follow-up, there was no surgical revision in the two groups, and there was no significant difference in the incidence of HO, ABL, and prosthesis subsidence between the two groups at last follow-up ( P>0.05). Imaging evaluation showed that there was no significant difference in CL, C 2-C 7 ROM, DA, DROM, and DIH between the two groups at each time point before and after operation ( P>0.05). The intra-group comparison showed that the early intervention group could maintain the immediate postoperative CL at last follow-up, while the late intervention group had recovered to the preoperative level. Additionally, the C 2-C 7 ROM, DROM, and DA had all recovered to preoperative levels at last follow-up in both groups; meanwhile, the DIH significantly increased immediately after operation and sustained until the last follow-up. Conclusion: Preoperative symptom duration significantly affects the effectiveness of CDA in CSR patients. Patients with preoperative symptom duration ≥24 months have longer postoperative hospital stays and potentially poorer ability to maintain CL compared with patients with preoperative symptom duration <24 months.

What Happens to Sagittal Alignment Following Laminoplasty Versus Laminectomy and Fusion?

OBJECTIVE: Laminectomy and fusion (LF) and laminoplasty (LP) are 2 sucessful posterior decompression techniques for cervical myelo-radiculopathy. There is also a growing body of evidence describing the importance of cervical sagittal alignment (CSA) and its importance in outcomes. We investigated the difference between pre- and postoperative CSA parameters in and between LF or LP. Furthermore, we studied predictive variables associated with change in cervical mismatch (CM). METHODS: This is a retrospective cohort study of adults with cervical myeloradiculopathy in a single healthcare system. The primary outcomes are intra- and inter-cohort comparison of LF versus LP radiographic parameters at pre- and postoperative time points. A secondary multivariable analysis of predictive factors was performed evaluating factors predicting postoperative CM. RESULTS: Eighty nine patients were included; 38 (43%) had LF and 51 (57%) underwent LP. Both groups decreased in lordosis (LF 11.4° vs. 4.9°, P = 0.01; LP 15.2° vs. 9.1°, P < 0.001), increased in cSVA (LF 3.4 vs. 4.2 cm, P = 0.01; LP 3.2 vs. 4.2 cm, P < 0.001), and increased in CM (LF 22.0° vs. 28.5°, P = 0.02; LP 16.8° vs. 22.3°, P = 0.002). There were no significant differences in the postoperative CSA between groups. No significant predictors of change in pre- and postoperative CM were found. CONSLUSIONS: There were no significant pre-or postoperative differences following the 2 procedures, suggesting radiographic equipoise in well indicated patients. Across all groups, lordosis decreased, cSVA increased, and cervical mismatch increased. There were no predictive factors that led to change in cervical mismatch.

C5 nerve root palsy (without prior cervical decompression) case series: 9 patients with critical delay to presentation.

BACKGROUND: Distinguishing between cervical nerve root and intrinsic shoulder pathology can be a difficult task given the overlapping and often coexisting symptoms. OBJECTIVE: The objective of this study was to highlight the often-complicated presentation of these symptoms and the subsequent potential for delay in care regarding this subset of patients. METHODS: A total of 9 patients, managed by one of two different surgeons, were identified with a history of C5 nerve root palsy. A chart review was conducted, and the following information was recorded: presenting complaint, time from symptom onset to diagnosis, time from symptom onset to presentation to a spine surgeon, first specialist seen for symptoms, non-spinal advanced imaging and treatment conducted before diagnosis, preoperative and postoperative exam, time to recovery, and type of surgery. RESULTS: We observed an average time from onset of symptoms to presentation to a spine surgeon to be 31.6 weeks. These patients' time to full recovery after cervical decompression was 15 weeks. CONCLUSION: : We observed a critical delay to presentation in this series of patients with C5 nerve palsy. C5 nerve palsy should remain an elemental part of the differential diagnosis in the setting of any shoulder or neck pain presenting with weakness.

Comparing outcomes between anterior cervical disc replacement (ACDR) and minimally invasive posterior cervical foraminotomy (MI-PCF) in the treatment of cervical radiculopathy.

BACKGROUND CONTEXT: Anterior cervical disc replacement (ACDR) and minimally invasive posterior cervical foraminotomy (MI-PCF) have emerged as two increasingly popular alternatives to anterior cervical discectomy and fusion (ACDF) for the management of cervical radiculopathy. Both techniques provide advantages of segmental motion preservation and lower rates of adjacent segment degeneration (ASD) compared to ACDF. PURPOSE: The purpose of this study was to analyze the clinical and functional outcomes of patients undergoing ACDR or MI-PCF for the treatment of unilateral cervical radiculopathy. STUDY DESIGN/SETTING: Retrospective Cohort Review. PATIENT SAMPLE: A total of 152 patients were included (86 ACDR and 66 MI-PCF). OUTCOME MEASURES: (1) Patient demographics; (2) perioperative data; (3) rates of complications and revisions; (5) visual analogue scale (VAS) and Neck Disability Index (NDI) scores. METHODS: A retrospective cohort review was performed to identify all patients at a single institution between 2012-2020 who underwent 1- or 2- level ACDR or MI-PCF from C3-C7 with a minimum follow-up of 24 months. Patient demographics, perioperative data, postoperative complications, and revisions were analyzed. Patient reported outcome measures including VAS and NDI scores were compared. RESULTS: The ACDR group had a significantly greater mean operative time (99.8 minutes vs 79.2 minutes, p<.001), but comparable estimated blood loss and length of stay following surgical intervention (p=.899). The overall complication rate was significantly greater in the ACDR group than the MI-PCF group (24.4% vs 6.2%; p=.003) but was largely driven by approach-related dysphagia in 20.9% of ACDR patients. The MI-PCF group had significantly greater revision rates (13.6% vs 1.2%; p=.002) with an average time to revision of 20.7 months in the MI-PCF group compared to 40.3 months in the ACDR group. The ACDR cohort had significantly greater improvements in NDI scores at the final follow-up (25.0 vs 21.3, p<.001). CONCLUSION: Our results suggest that ACDR offer clinically relevant advantages over MI-PCF in terms of long-term revision rates despite an increased approach-related risk of transient postoperative dysphagia. Additionally, patients in the ACDR cohort achieved greater mean improvements in NDI scores but these results may have limited clinical significance due to inability to reach minimally clinically important difference (MCID) thresholds.

Is neck pain treatable with surgery?

INTRODUCTION: Neck pain is one of the most common complaints in clinical practice and can be caused by a wide variety of conditions. While cervical spine surgery is a well-accepted option for radicular pain and myelopathy, surgery for isolated neck pain is controversial. The identification of the source of pain is challenging and subtle, and misdiagnosis can lead to inappropriate treatment. MATERIALS AND METHODS AND RESULTS: We conducted a thorough literature review to discuss and compare different causes of neck pain. We then supplemented the literature with our senior author's expert analysis of treating cervical spine pathology. CONCLUSIONS: This study provides an in-depth discussion of neck pain and its various presentations, as well as providing insight into treatment strategies and diagnostic pearls that may prevent mistreatment of cervical spine pathology.

Upstream Effects: Intraoperative Migration of Intradural Extramedullary Tumor After Non-Adjacent Level Stenosis Decompression.

A 74-year-old man with back pain, foot numbness, and hip/thigh radiculopathy was found to have an L1-L2 intradural extramedullary neoplasm and severe L4-L5 stenosis. L4-L5 minimally invasive laminectomy for decompression and concomitant L1-L2 minimally invasive laminectomy for tumor resection were planned. L4-L5 laminectomy was completed first followed by the L1-L2 laminectomy. On extensive intradural exploration at L1-L2, no neoplasm was found. Immediate postoperative imaging showed that the intradural extramedullary tumor had migrated caudally by nearly a complete spinal level, presumably due to changes in cerebrospinal fluid pressure and resultant shift in intradural contents after the L4-L5 laminectomy. Successful resection of the intradural extramedullary tumor was performed, with improvement in the patient's symptoms.

Influence of Preoperative Pain, Cognitions, and Quantitative Sensory Testing Measures on the Effects of Perioperative Pain Neuroscience Education for People Receiving Surgery for Lumbar Radiculopathy: Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVE: To explore whether preoperative pain intensity, pain cognitions, and quantitative sensory measures influence the established effectiveness of perioperative pain neuroscience education (PPNE) on health-related quality of life at 1 year after surgery for lumbar radiculopathy. DESIGN: Secondary analysis of a triple-blinded randomized controlled trial. METHODS: Participants (n = 90) were Dutch-speaking adults (18-65 years) who were scheduled for surgery for lumbar radiculopathy in 3 Belgian hospitals. They were randomized (1:1) to receive PPNE (n = 41) or perioperative biomedical education (n = 49). Linear mixed models were built for health-related quality of life (ie, SF-6D utility values, Physical and Mental Component of the 36-item Short Form Health Survey) using the following independent variables: therapy, time, and preoperative scores for back and leg pain intensity, pain catastrophizing, kinesiophobia, hypervigilance, and quantitative sensory measures. RESULTS: The impact of PPNE on SF-6D utility values over time was influenced by kinesiophobia (F = 3.30, P = .02) and leg pain intensity (F = 3.48, P = .02). Regardless of the intervention, back pain intensity negatively influenced SF-6D values over time (F = 3.99, P = .009). The Physical Component scores were negatively impacted by back pain intensity (F = 9.08, P = .003) and were influenced over time by leg pain intensity (F = 2.87, P = .04). The Mental Component scores were negatively impacted by back pain intensity (F = 6.64, P = .01) and pain catastrophizing (F = 5.42, P = .02), as well as hypervigilance (F = 3.16, P = .03) and leg pain intensity (F = 3.12, P = .03) over time. CONCLUSION: PPNE may be more effective than perioperative biomedical education in improving postoperative health utility values in patients who reported higher kinesiophobia and leg pain intensity before surgery for lumbar radiculopathy. J Orthop Sports Phys Ther 2024;54(4):1-10. Epub 8 January 2024. doi:10.2519/jospt.2024.12051.

Long-Term (>24 Months) Duration of Symptoms Negatively Impacts Patient-Reported Outcomes Following Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To investigate the impact of long symptom duration (>24 mo) on patient self-reported outcomes for pain, function, and quality of life following anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy. SUMMARY OF BACKGROUND DATA: ACDF is an effective treatment to relieve the symptoms of cervical radiculopathy. However, there is no consensus on whether prolonged preoperative length of symptoms negatively impacts postoperative outcomes. METHODS: This study included consecutive patients who underwent ACDF for cervical radiculopathy from May 1, 2012 to Dec 1, 2019 by a single surgeon. Patients were stratified by short (<24 mo) and long (>24 mo) duration of symptoms. Outcomes including visual analog scale (VAS) neck and arm, neck disability index (NDI), EuroQol-5D (EQ-5D), and overall state of health (EQ-VAS) were compared between cohort both for absolute values and percentage of patients achieving minimal clinically important difference. RESULTS: A total of 111 consecutive patients were included in our study, including 59 patients in the short symptom duration group and 52 patients in the long symptom duration group. The mean age of the patients was 51.4±9.4 and 41 (36.9%) were female. The baseline VAS neck and arm, NDI, EQ-5D, and EQ-VAS were similar between groups. Patients in both long and short symptom duration groups had clinical improvement following surgery. However, patients with short symptom duration had better VAS Neck and EQ-5D outcomes, and were more likely to meet minimal clinically important difference for NDI, EQ-5D, or any outcome. Multivariate analysis confirmed symptom duration <24 months as an independent predictor for better patient-reported outcomes. CONCLUSION: We appreciated better clinical outcomes in patients with shorter symptom duration who received ACDF for cervical radiculopathy. On the basis of this data, we advocate for prompt treatment of cervical radiculopathy to avoid the potential for long-term impairment. LEVEL OF EVIDENCE: Level 3.

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.

Channel-assisted cervical key hole technology combined with ultrasonic bone osteotome versus posterior percutaneous endoscopic cervical foraminotomy: a clinical retrospective study.

PURPOSE: The search for more effective and safe treatment methods for cervical spondylotic radiculopathy (CSR) has led to the rapid development and increasing popularity of minimally invasive posterior cervical foraminotomy (MI-PCF). This study aims to compare two important approaches for MI-PCF surgery: the channel-assisted cervical key hole technology combined with ultrasonic bone osteotome (CKH-UBO) and posterior percutaneous endoscopic cervical foraminotomy (PPECF). METHODS: Data from patients treated with single-level CKH-UBO (n = 35) or PPECF (n = 40) were analyzed. Clinical outcomes, including visual analogue scale (VAS) scores for neck and arm pain, Neck Disability Index (NDI), and modified Macnab criteria, were assessed preoperatively, as well as at three days, three months, and one year postoperatively. RESULTS: The percentages of patients with excellent and good outcomes were 97.14% and 92.5%, respectively. The average surgical time in the CKH-UBO group was significantly shorter than in the PPECF group (p < 0.001), while the average incision length in the PPECF group was significantly smaller than in the CKH-UBO group. There were no significant differences between the two groups in terms of blood loss, hospital stay, and clinical outcomes at three days, three months, and 12 months postoperatively. CONCLUSION: CKH-UBO can achieve the same surgical outcomes as PPECF for the treatment of CSR. However, CKH-UBO saves more time but requires patients to undergo larger incisions.