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

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.

scholarly journals Adjacent-level arthroplasty following cervical fusion

2017 ◽  
Vol 42 (2) ◽  
pp. E5 ◽  
Author(s):  
Deshpande V. Rajakumar ◽  
Akshay Hari ◽  
Murali Krishna ◽  
Subhas Konar ◽  
Ankit Sharma
Keyword(s):  
Cobb Angle ◽  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Cervical Fusion ◽  
Adjacent Level ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Cervical Arthroplasty ◽  
Arm Pain

OBJECTIVE Adjacent-level disc degeneration following cervical fusion has been well reported. This condition poses a major treatment dilemma when it becomes symptomatic. The potential application of cervical arthroplasty to preserve motion in the affected segment is not well documented, with few studies in the literature. The authors present their initial experience of analyzing clinical and radiological results in such patients who were treated with arthroplasty for new or persistent arm and/or neck symptoms related to neural compression due to adjacent-segment disease after anterior cervical discectomy and fusion (ACDF). METHODS During a 5-year period, 11 patients who had undergone ACDF anterior cervical discectomy and fusion (ACDF) and subsequently developed recurrent neck or arm pain related to adjacent-level cervical disc disease were treated with cervical arthroplasty at the authors' institution. A total of 15 devices were implanted (range of treated levels per patient: 1–3). Clinical evaluation was performed both before and after surgery, using a visual analog scale (VAS) for pain and the Neck Disability Index (NDI). Radiological outcomes were analyzed using pre- and postoperative flexion/extension lateral radiographs measuring Cobb angle (overall C2–7 sagittal alignment), functional spinal unit (FSU) angle, and range of motion (ROM). RESULTS There were no major perioperative complications or device-related failures. Statistically significant results, obtained in all cases, were reflected by an improvement in VAS scores for neck/arm pain and NDI scores for neck pain. Radiologically, statistically significant increases in the overall lordosis (as measured by Cobb angle) and ROM at the treated disc level were observed. Three patients were lost to follow-up within the first year after arthroplasty. In the remaining 8 cases, the duration of follow-up ranged from 1 to 3 years. None of these 8 patients required surgery for the same vertebral level during the follow-up period. CONCLUSIONS Artificial cervical disc replacement in patients who have previously undergone cervical fusion surgery appears to be safe, with encouraging early clinical results based on this small case series, but more data from larger numbers of patients with long-term follow-up are needed. Arthroplasty may provide an additional tool for the management of post-fusion adjacent-level cervical disc disease in carefully selected patients.

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

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.

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

2021 ◽  
Vol 50 (6) ◽  
pp. E7
Author(s):  
Alec W. Gibson ◽  
Abdullah H. Feroze ◽  
Madeline E. Greil ◽  
Margaret E. McGrath ◽  
Sananthan Sivakanthan ◽  
...  
Keyword(s):  
Neck Disability Index ◽  
Bone Allograft ◽  
Cervical Radiculopathy ◽  
Anterior Cervical Discectomy ◽  
High Rate ◽  
Cervical Discectomy ◽  
Arm Pain ◽  
Scale Scores ◽  
Neck Disability

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.

scholarly journals 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 ◽  
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

Analysis of the three United States Food and Drug Administration investigational device exemption cervical arthroplasty trials

2012 ◽  
Vol 16 (3) ◽  
pp. 216-228 ◽  
Author(s):  
Cheerag D. Upadhyaya ◽  
Jau-Ching Wu ◽  
Gregory Trost ◽  
Regis W. Haid ◽  
Vincent C. Traynelis ◽  
...  
Keyword(s):  
Random Effects ◽  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Adjacent Level ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Single Level ◽  
Investigational Device Exemption ◽  
Time Point

Object There are now 3 randomized, multicenter, US FDA investigational device exemption, industry-sponsored studies comparing arthroplasty with anterior cervical discectomy and fusion (ACDF) for single-level cervical disease with 2 years of follow-up. These 3 studies evaluated the Prestige ST, Bryan, and ProDisc-C artificial discs. The authors analyzed the combined results of these trials. Methods A total of 1213 patients with symptomatic, single-level cervical disc disease were randomized into 2 treatment arms in the 3 randomized trials. Six hundred twenty-one patients received an artificial cervical disc, and 592 patients were treated with ACDF. In the three trials, 94% of the arthroplasty group and 87% of the ACDF group have completed 2 years of follow-up. The authors analyzed the 2-year data from these 3 trials including previously unpublished source data. Statistical analysis was performed with fixed and random effects models. Results The authors' analysis revealed that segmental sagittal motion was preserved with arthroplasty (preoperatively 7.26° and postoperatively 8.14°) at the 2-year time point. The fusion rate for ACDF at 2 years was 95%. The Neck Disability Index, 36-Item Short Form Health Survey Mental, and Physical Component Summaries, neck pain, and arm pain scores were not statistically different between the groups at the 24-month follow-up. The arthroplasty group demonstrated superior results at 24 months in neurological success (RR 0.595, I2 = 0%, p = 0.006). The arthroplasty group had a lower rate of secondary surgeries at the 2-year time point (RR 0.44, I2 = 0%, p = 0.004). At the 2-year time point, the reoperation rate for adjacent-level disease was lower for the arthroplasty group when the authors analyzed the combined data set using a fixed effects model (RR 0.460, I2 = 2.9%, p = 0.030), but this finding was not significant using a random effects model. Adverse event reporting was too heterogeneous between the 3 trials to combine for analysis. Conclusions Both anterior cervical discectomy and fusion as well as arthroplasty demonstrate excellent 2-year surgical results for the treatment of 1-level cervical disc disease with radiculopathy. Arthroplasty is associated with a lower rate of secondary surgery and a higher rate of neurological success at 2 years. Arthroplasty may be associated with a lower rate of adjacent-level disease at 2 years, but further follow-up and analysis are needed to confirm this finding.

scholarly journals Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc

2018 ◽  
Vol 28 (3) ◽  
pp. 252-261 ◽  
Author(s):  
Domagoj Coric ◽  
Richard D. Guyer ◽  
Pierce D. Nunley ◽  
David Musante ◽  
Cameron Carmody ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Total Disc Replacement ◽  
Neck Disability Index ◽  
The United States ◽  
Anterior Cervical Discectomy ◽  
Artificial Disc ◽  
Cervical Discectomy ◽  
Metal On Metal ◽  
Ion Analysis

OBJECTIVESeven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up.METHODSAn FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR.RESULTSA total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but was significantly greater than the preoperative mean value at the 12- and 24-month follow-ups and remained significantly improved through the 60-month period. There were no significant differences between the 2 groups in terms of reoperation/revision surgery or device-/surgery-related adverse events. The serum ion analysis revealed cobalt and chromium levels significantly lower than the levels that merit monitoring.CONCLUSIONSCervical TDR with an MoM device is safe and efficacious at the 5-year follow-up. These results from a prospective randomized study support that Kineflex|C TDR as a viable alternative to ACDF in appropriately selected patients with cervical radiculopathy.Clinical trial registration no.: NCT00374413 (clinicaltrials.gov)

scholarly journals The Functional outcome following anterior cervical discectomy and fusion for single level cervical degenerative disc disease: a prospective single institutional study

2020 ◽  
Vol 17 (2) ◽  
pp. 42-47
Author(s):  
Somraj Lamichhane ◽  
Sujata Panta ◽  
Devendra Acharya
Keyword(s):  
Degenerative Disc Disease ◽  
Cervical Spondylotic Myelopathy ◽  
Anterior Cervical Discectomy ◽  
Disc Disease ◽  
Cervical Discectomy ◽  
Degenerative Disc ◽  
Single Level ◽  
Cervical Degenerative Disc Disease ◽  
Severe Grade

Introduction: Cervical degenerative disc diseases leading to cervical spondylotic myelopathy (CSM) is one the most common cause of disability in elderly population that progresses with age with continuation of degree of degeneration. Objective: To assess the functional outcome following ACDF in single-level cervical degenerative disc disease in terms of improvement in the mJOA scoring system and postoperative complications. Materials and methods: Eighteen patients with single level cervical degenerative disc diseases who presented at the college of medical sciences from May 2018 to October 2019 fulfilling the inclusion criteria (single-level cervical degenerative disc disease with age between 40 to 70 years with progressive neurological deficits, features of cervical spondylotic myelopathy and patients with mild grade who failed four weeks of conservative treatment and progressed to moderate or severe grades) were included in the study. All patients underwent Anterior Cervical Discectomy and Fusion (ACDF); with tricortical iliac crest graft with cervical plate and screws in 13 patients and polyether ether ketone (PEEK) cage placement in five patients. Patients were assessed using mJOA scoring system and graded into mild, moderate and severe myelopathy. Post-operatively patients were assessed for improvement in terms of mJOA scores at four weeks and three months follow-up. They were also assessed for development of any post-operative complications and documented accordingly. Statistical analysis was done using the Statistical Package for the Social Sciences version 20 software. Results: Out of 18 patients, at the time of presentation 12 were in moderate grade and six were in severe grade. During subsequent follow up at four weeks and three months, patients showed progressive improvement. 15 patients improved to mild grade while two remained in moderate grade and one in severe grade during three months postoperative assessment. One patient each developed dysphagia, hoarseness and superficial wound infection that were managed conservatively. Conclusion: Anterior cervical discectomy and fusion is one of the effective and safe treatments for single-level degenerative cervical disc disease associated with cervical spondylotic myelopathy with minimal complications.

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