Cellular allograft for multilevel stand-alone anterior cervical discectomy and fusion

OBJECTIVE Anterior cervical discectomy and fusion (ACDF) is the most common treatment for degenerative disease of the cervical spine. Given the high rate of pseudarthrosis in multilevel stand-alone ACDF, there is a need to explore the utility of novel grafting materials. In this study, the authors present a single-institution retrospective study of patients with multilevel degenerative spine disease who underwent multilevel stand-alone ACDF surgery with or without cellular allograft supplementation. METHODS In a prospectively collected database, 28 patients who underwent multilevel ACDF supplemented with cellular allograft (ViviGen) and 25 patients who underwent multilevel ACDF with decellularized allograft between 2014 and 2020 were identified. The primary outcome was radiographic fusion determined by a 1-year follow-up CT scan. Secondary outcomes included change in Neck Disability Index (NDI) scores and change in visual analog scale scores for neck and arm pain. RESULTS The study included 53 patients with a mean age of 53 ± 0.7 years who underwent multilevel stand-alone ACDF encompassing 2.6 ± 0.7 levels on average. Patient demographics were similar between the two cohorts. In the cellular allograft cohort, 2 patients experienced postoperative dysphagia that resolved by the 3-month follow-up. One patient developed cervical radiculopathy due to graft subsidence and required a posterior foraminotomy. At the 1-year CT, successful fusion was achieved in 92.9% (26/28) of patients who underwent ACDF supplemented with cellular allograft, compared with 84.0% (21/25) of patients who underwent ACDF without cellular allograft. The cellular allograft cohort experienced a significantly greater improvement in the mean postoperative NDI score (p < 0.05) compared with the other cohort. CONCLUSIONS Cellular allograft is a low-morbidity bone allograft option for ACDF. In this study, the authors determined favorable arthrodesis rates and functional outcomes in a complex patient cohort following multilevel stand-alone ACDF supplemented with cellular allograft.

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Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion

Global Spine Journal ◽

10.1177/2192568220914880 ◽

2020 ◽

pp. 219256822091488

Author(s):

Paul M. Arnold ◽

Alexander R. Vaccaro ◽

Rick C. Sasso ◽

Benoit Goulet ◽

Michael G. Fehlings ◽

...

Keyword(s):

Short Form ◽

Secondary Analysis ◽

Neck Disability Index ◽

Cervical Radiculopathy ◽

Anterior Cervical Discectomy ◽

Disc Disease ◽

Cervical Discectomy ◽

Single Level ◽

Arm Pain ◽

Patients With Diabetes

Study Design: Secondary analysis of data from the multicenter, randomized, parallel-controlled Food and Drug Administration (FDA) investigational device exemption study. Objective: Studies on outcomes following anterior cervical discectomy and fusion (ACDF) in individuals with diabetes are scarce. We compared 24-month radiological and clinical outcomes in individuals with and without diabetes undergoing single-level ACDF with either i-FACTOR or local autologous bone. Methods: Between 2006 and 2013, 319 individuals with single-level degenerative disc disease (DDD) and no previous fusion at the index level underwent ACDF. The presence of diabetes determined the 2 cohorts. Data collected included radiological fusion evaluation, neurological outcomes, Neck Disability Index (NDI), Visual Analog Scale (VAS) scores, and the 36-Item Short Form Survey Version 2 (SF-36v2) Physical and Mental component summary scores. Results: There were 35 individuals with diabetes (11.1%; average body mass index [BMI] = 32.99 kg/m2; SD = 5.72) and 284 without (average BMI = 28.32 kg/m2; SD = 5.67). The number of nondiabetic smokers was significantly higher than diabetic smokers: 73 (25.70%) and 3 (8.57%), respectively. Preoperative scores of NDI, VAS arm pain, and SF-36v2 were similar between the diabetic and nondiabetic participants at baseline; however, VAS neck pain differed significantly between the cohorts at baseline ( P = .0089). Maximum improvement for NDI, VAS neck and arm pain, and SF-36v2 PCS and MCS scores was seen at 6 months in both cohorts and remained stable until 24 months. Conclusions: ACDF is effective for cervical radiculopathy in patients with diabetes. Diabetes is not a contraindication for patients requiring single-level surgery for cervical DDD.

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Posterior percutaneous full-endoscopic cervical discectomy under local anesthesia for cervical radiculopathy due to soft-disc herniation: a preliminary clinical study

Journal of Neurosurgery Spine ◽

10.3171/2018.1.spine17795 ◽

2018 ◽

Vol 29 (4) ◽

pp. 351-357 ◽

Cited By ~ 8

Author(s):

Quan Wan ◽

Daying Zhang ◽

Shun Li ◽

Wenlong Liu ◽

Xiang Wu ◽

...

Keyword(s):

Local Anesthesia ◽

Disc Herniation ◽

Clinical Success ◽

Neck Disability Index ◽

Cervical Radiculopathy ◽

Functional Improvement ◽

Promising Alternative ◽

Cervical Discectomy ◽

Neck Disability

OBJECTIVETo the authors’ knowledge, posterior percutaneous full-endoscopic cervical discectomy (PPFECD) has not been reported before as a procedure performed with patients under local anesthesia (LA). In this study, the authors report the outcomes of 25 patients treated by this technique, the surgical steps, and the procedure’s potential advantages.METHODSTwenty-five patients diagnosed with cervical radiculopathy due to soft-disc herniation (SDH) were treated by PPFECD. The intensities of arm and neck pain were measured using the visual analog scale (VAS) and the functional status was assessed using the Neck Disability Index (NDI) preoperatively and at 1, 3, 6, and 12 months postoperatively. Global outcome was also assessed using modified Macnab criteria, and outcomes were grouped as clinical success (excellent or good) and clinical failure (fair or poor). Complications were also recorded.RESULTSNo patient was lost to the follow-up. Significant and durable pain relief and cervical functional improvement were achieved postoperatively. Clinical success was achieved in 24 patients (96%), including 22 excellent and 2 good outcomes at the last follow-up. No serious complications occurred.CONCLUSIONSThe authors’ preliminary experience indicates that PPFECD under LA is a feasible and promising alternative for selected cases of cervical radiculopathy due to SDH, though the procedure’s effectiveness and safety still need confirmation from further studies.

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STAND-ALONE CERVICAL CAGE FOR CERVICAL RADICULOPATHY: A RETROSPECTIVE STUDY

(JOINTS) Journal Orthopaedi and Traumatology Surabaya ◽

10.20473/joints.v9i1.2020.17-21 ◽

2020 ◽

Vol 9 (1) ◽

pp. 17

Author(s):

I Ketut Martiana ◽

Reyner Valiant Tumbelaka

Keyword(s):

Neck Disability Index ◽

Cervical Radiculopathy ◽

Surgical Method ◽

Arm Pain ◽

Phone Calls ◽

Specific Muscle ◽

Muscle Groups ◽

Hospital Institution ◽

Neck Disability

Introduction: Cervical radiculopathy is a clinical condition characterized by unilateral arm pain, numbness and tingling in a dermatomal distribution in the hand, and weakness in specific muscle groups that can be treated with nonsurgical or surgical method. This study aims to evaluate the outcome of the stand-alone cervical cage surgical method for cervical radiculopathy in our hospital institution from 2013 to 2017Methods: This is a retrospective observational study on every patient who undergoes a stand-alone cervical cage for cervical radiculopathy in our hospital institution from 2013 to 2017. The study runs from December 2017 until April 2018. We evaluated the clinical outcome with the Neck Disability Index (NDI). The data were collected from medical records, and postoperative follow up is done by house visits, phone calls, and outpatient visits.Results: Five male and one female subjects with a mean age of 58 years old (45–65 years old) underwent the procedure; one patient passed away on three year postoperative due to other events not related to operation procedure; one patient could no longer be reached. Four patient has an increasing score of NDI postoperative. There is no postoperative complicationConclusion: Stand-alone cervical cage is an excellent treatment for cervical radiculopathy in our hospital institution from 2013 to 2017.

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Pseudarthrosis in anterior cervical discectomy and fusion with a self-locking, stand-alone cage filled with hydroxyapatite: a retrospective study with clinical and radiological outcomes of 98 levels with a minimum 2-year follow-up

Journal of Neurosurgery Spine ◽

10.3171/2020.4.spine20357 ◽

2020 ◽

Vol 33 (6) ◽

pp. 717-726

Author(s):

Eduardo A. Iunes ◽

Enrico A. Barletta ◽

Telmo A. B. Belsuzarri ◽

Franz J. Onishi ◽

André Y. Aihara ◽

...

Keyword(s):

Statistical Significance ◽

Neck Disability Index ◽

Wilcoxon Test ◽

Anterior Cervical Discectomy ◽

Adjacent Level ◽

Disc Disease ◽

Cervical Discectomy ◽

Arm Pain ◽

Pain Status

OBJECTIVEThe goal of this study was to evaluate the incidence of pseudarthrosis after the treatment of cervical degenerative disc disease (CDDD) with anterior cervical discectomy and fusion (ACDF) in which self-locking, stand-alone intervertebral cages filled with hydroxyapatite were used.METHODSThe authors performed a retrospective cohort study of 49 patients who underwent 1- to 3-level ACDF with self-locking, stand-alone intervertebral cages without plates, with a minimum 2 years of follow-up. The following data were extracted from radiological and clinical charts: age, sex, time and type of pre- and postoperative signs and symptoms, pain status (visual analog scale [VAS]), functional status (Neck Disability Index [NDI]), history of smoking, bone quality (bone densitometry), and complications. Pseudarthrosis was diagnosed by a blinded neuroradiologist using CT scans. Clinical improvement was assessed using pre- and postoperative comparison of VAS and NDI scores. The Wilcoxon test for paired tests was used to evaluate statistical significance using a p value of < 0.05.RESULTSThree patients (6%) developed symptomatic pseudarthrosis requiring reoperation, with only 1 patient showing clinical worsening due to pseudarthrosis, while the other 2 with pseudarthrosis had associated disc disease at an adjacent level. The rate of symptomatic pseudarthrosis according to the number of operated levels was 0% for 1 level, 8.7% (2/23 patients) for 2 levels, and 7.7% (1/13 patients) for 3 levels. The total pseudarthrosis rate (including both symptomatic and asymptomatic patients) was 16.4%. Considering the clinical outcomes, there was a significant improvement of 75.6% in neck pain and 95.7% in arm pain, as well as a 64.9% improvement in NDI scores. Complications were observed in 18.4% of patients, with adjacent-level degenerative disease being the most prevalent at 14.3%.CONCLUSIONSACDF with self-locking, stand-alone cages filled with a hydroxyapatite graft can be used for the surgical treatment of 1- to 3-level CDDD with clinical and radiological outcomes significantly improved after a minimum 2-year follow-up period. Comparative studies are necessary.

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Is the improvement of cervical alignment really essential after three-level anterior cervical discectomy and fusion? A minimal 5-year follow-up

10.21203/rs.2.20402/v1 ◽

2020 ◽

Author(s):

Yan Liang ◽

Shuai Xu ◽

Guanjie Yu ◽

Zhenqi Zhu ◽

Haiying Liu

Keyword(s):

Japanese Orthopaedic Association ◽

Neck Disability Index ◽

Adjacent Segment Degeneration ◽

Anterior Cervical Discectomy ◽

Adjacent Segment ◽

Cervical Discectomy ◽

Cervical Alignment ◽

Neck Disability

Abstract Purpose: To identify the importance of sagittal alignment with self-locked stand-alone cage (SSC) and anterior cage-with-plate (ACP) system after 3-level anterior cervical discectomy and fusion (ACDF) on cervical spondylotic myelopathy (CSM) after minimal 5-year follow-up.Methods: 38 patients with SSC system (SSC group) and 26 with ACP system (ACP group) from February 2007 to September 2013 were enrolled. Cervical alignment were C2-7 lordosis (CL), operated-segment CL (OPCL), upper and lower adjacent-segment CL (UCL and LCL) at preoperation (POP), immediate postoperation (IPO) and final follow-up (FFU). Clinical outcomes contained the neck disability index (NDI), the Japanese Orthopaedic Association (JOA) score and adjacent segment degeneration (ASD). Patients were divides into CL improved subgroup (IM subgroup) and non-improved subgroup (NIM subgroup).Results: There were improvements on CL and OPCL in both groups. The change of CL and OPCL larger in ACP group (P<0.05) but UAL and LAL were of no significance. NDI and JOA got improvement in both groups at IPO and FFU while ASD was in no difference between SSC and ACP. A total of 40 patients (18 vs 22) acquired CL improvement with a larger population in ACP group. There were no differences on the rate if ASD, NDI, JOA and their change between IM and NIM subgroup and the change of CL were not correlated with NDI, JOA and their change.Conclusion: SSC and ACP both provide long-term efficacy on OPCL correction with little impact on adjacent segment. The improvement of CL after three-level ACDF seems not so essential.

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i-Factor™ Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug Administration Investigational Device Exemption Study

Neurosurgery ◽

10.1093/neuros/nyx432 ◽

2017 ◽

Vol 83 (3) ◽

pp. 377-384 ◽

Cited By ~ 7

Author(s):

Paul M Arnold ◽

Rick C Sasso ◽

Michael E Janssen ◽

Michael G Fehlings ◽

Robert F Heary ◽

...

Keyword(s):

Bone Graft ◽

Visual Analog Scale ◽

Neck Disability Index ◽

Anterior Cervical Discectomy ◽

Analog Scale ◽

Cervical Discectomy ◽

Investigational Device Exemption ◽

I Factor ◽

Neck Disability

Abstract BACKGROUND i-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. OBJECTIVE To report 2-yr follow-up. METHODS Subjects randomly received either autograft (n = 154) or i-Factor™ (n = 165) in a cortical ring allograft and followed using radiological, clinical, and patient-reported outcomes. RESULTS At 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively (P = .2513), and neurological success rate was 94.87% (i-Factor™) and 93.79% (autograft; P = .7869). Neck Disability Index improved 28.30 (i-Factor™) and 26.95 (autograft; P = .1448); Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p = .2763); Visual Analog Scale neck pain improved 4.78 (i-Factor™) and 4.41 (autograft; P = .1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor™) and 10.18 (autograft; P = .4507), and SF36v2 Mental Component Score improved 7.88 (i-FactorTM) and 7.53 (autograft; P = .9872). The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of re-operations) was greater in i-Factor™ subjects compared to autograft subjects (69.83% and 56.35%, respectively, P = .0302). Twelve (7.45%) i-Factor™ subjects and 16 (10.53%) autograft subjects underwent re-operation (P = .3411). There were no allergic reactions associated with i-Factor™. CONCLUSION Use of i-Factor™ in anterior cervical discectomy and fusion is effective and safe, and results in similar outcomes compared to local autograft bone at 2 yr following surgery.

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A Long-Term Control Study of the Treatment of Cervical Radiculopathy by Percutaneous Endoscopic Posterior Cervical Discectomy and Anterior Cervical Decompression, Bone Graft Fusion and Internal Fixation

10.21203/rs.3.rs-78852/v1 ◽

2020 ◽

Author(s):

Xiaodong Huang ◽

Weiheng Wang ◽

Qingxi Meng ◽

Jiangming Yu ◽

Xiaojian Ye

Keyword(s):

Clinical Symptoms ◽

Neck Disability Index ◽

Cervical Radiculopathy ◽

Clinical Results ◽

Cervical Discectomy ◽

Anterior Cervical Decompression ◽

Intermediate Outcomes ◽

Significant Difference ◽

Neck Disability

Abstract BackgroundCervical spondylotic radiculopathy (CSR) is very common all over the world. However, there are only a few reports about the efficacy of percutaneous endoscopic posterior cervical discectomy (PEPCD) in the treatment of CSR. Anterior cervical decompression and fusion (ACDF) and PEPCD which is a better way to treat CSR need further study.MethodsFrom January 2015 to December 2016. A retrospective study of 70 patients undergoing surgery for CSR (33 using PEPCD and 37 using ACDF). The intra-operative parameters, neck disability index (NDI), neck and arm visual analog scale (VAS) score were used to assessed clinical outcome. Radiological outcomes were assessed by measuring cervical 2-7 (C2-7) lordosis, disc height index (DHI), and degree of degenerative changes at the corresponding level.ResultsThe mean follow-up period was 48.5 month (36 –66 months). Two groups can significantly improve the clinical symptoms. There was no significant difference between the two groups in clinical results (VAS, NDI). Compared with preoperative, the lordosis of C2-7 increased significantly at the last follow-up. At the last follow-up, C2-7 lordosis in the ACDF group was significantly higher than that in the PEPCD group. In PEPCD, compared with preoperative, there was no significant difference in the DHI, but the degree of disc degeneration was significantly increased at the last follow-up.ConclusionFor patients with CSR, PEPCD had similar clinical early and intermediate outcomes when compared with ACDF, with the advantages of minimally invasive. PEPCD is a sufficient and safe supplement and alternative to conventional surgery.

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Partial uncinatectomy combined with anterior cervical discectomy and fusion for the treatment of one-level cervical radiculopathy: analysis of clinical efficacy and sagittal alignment

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-04680-0 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Haimiti Abudouaini ◽

Tingkui Wu ◽

Hao Liu ◽

Beiyu Wang ◽

Hua Chen ◽

...

Keyword(s):

Clinical Efficacy ◽

Sagittal Alignment ◽

Cervical Radiculopathy ◽

Fusion Rate ◽

Uncinate Process ◽

Anterior Cervical Discectomy ◽

Cervical Discectomy ◽

Cervical Sagittal Alignment ◽

Uncovertebral Joint

Abstract Background Biomechanical studies have demonstrated that uncovertebral joint contributes to segment mobility and stability to a certain extent. Simultaneously, osteophytes arising from the uncinate process are a common cause of cervical spondylotic radiculopathy (CSR). For such patients, partial uncinatectomy (UT) may be required. However, the clinical efficacy and sagittal alignment of partial UT during anterior cervical discectomy and fusion (ACDF) have not been fully elucidated. Methods A total of 87 patients who had undergone single level ACDF using a zero-profile device from July 2014 to December 2018 were included. Based on whether the foraminal part of the uncovertebral joint was resected or preserved, the patients were divided into the ACDF with UT group (n = 37) and the ACDF without UT group (n = 50). Perioperative data, radiographic parameters, clinical outcomes, and complications were compared between the two groups. Results The mean follow-up was 16.86 ± 5.63 and 18.36 ± 7.51 months in the ACDF with UT group and ACDF without UT group, respectively (p > 0.05). The average preoperative VAS arm score was 5.89 ± 1.00 in the ACDF with UT group and 5.18 ± 1.21 in the ACDF without UT group (p = 0.038). However, the average VAS arm score was 4.22 ± 0.64, 4.06 ± 1.13 and 1.68 ± 0.71, 1.60 ± 0.70 at 1 week post operation and at final follow up, respectively, (p > 0.05). We also found that the C2-7 SVA and St-SVA at the last follow-up and their change (last follow-up value − preoperative value) in the ACDF with UT group were significantly higher than ACDF without UT group (p < 0.05). No marked differences in the other cervical sagittal parameters, fusion rate or complications, including dysphagia, ASD, and subsidence, were observed. Conclusions Our result indicates that ACDF using a zero-p implant with or without partial UT both provide satisfactory clinical efficacy and acceptable safety. However, additional partial UT may has a negative effect on cervical sagittal alignment.

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Anterior cervical discectomy and fusion with polyetheretherketone cages in the management of single and double level cervical spondylotic myelopathy-our experiences of 80 cases

KYAMC Journal ◽

10.3329/kyamcj.v9i1.36622 ◽

2018 ◽

Vol 9 (1) ◽

pp. 32-34

Author(s):

Md Anowarul Islam ◽

Mohd Alamgir Hossain ◽

Ahmed Asif Iqbal ◽

Md Qumruzzaman Parvez ◽

Md Ahsanuzzaman ◽

...

Keyword(s):

Clinical Outcome ◽

Donor Site ◽

Fusion Rate ◽

Anterior Cervical Discectomy ◽

Cervical Discectomy ◽

X Ray ◽

Arm Pain ◽

Operative Complications ◽

Medical University

Background: Anterior cervical discectomy with fusion (ACDF) is challenging with respect to both patient selection and choice of surgical procedure.Objectives: The aim of this study was to evaluate the clinical outcome of anterior cervical discectomy and fusion with an artificial cage made of polyetheretherketoneMaterials & Methods: From January 2012 to January 2017, 80 consecutive patients referred to the Department of spine surgery, Bangabandhu Shekh Mujib Medical University were recruited for the study. Postoperative Clinical outcome assessed with Nurick scale for myelopathy, Odom's criteria for functional outcome and Visual Analogue Scale (VAS) for both neck and arm pain. Radiological fusion was assessed by X-ray. Operative complications were reported.Results: 36 patients were operated for one level discectomy and fusion with PEEK cages and 44 patients for two levels. There were 48 (60%) males and 32 (40%) females. The age of the patients ranged from 30-72 years, a mean ± SD 45 ± 8.34. At the 2 years clinical follow-up, there were significant post operative improvements of Nurick scale, and VAS comparative to preoperative record. According to Odom's criteria, 72/80 patients (90%) were graded excellent-good.Conclusion: Anterior cervical discectomy and fusion with polyetheretherketone (PEEK) cage is an effective treatment of cervical myelopathy having higher fusion rate and lack of donor site morbidity.KYAMC Journal Vol. 9, No.-1, April 2018, Page 32-34

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