Clinical Studies of Anterior Cervical Fusion with PEEK Cages: Comparing Iliac Graft and a Macroporous Biphasic Calcium Phosphate

2012 ◽  
Vol 529-530 ◽  
pp. 261-265
Author(s):  
G. Daculsi ◽  
H. Pascal-Moussellard

The objective of the study was to compare clinical efficiency of the fusion after reconstruction with an anatomically shaped PEEK cage associated with a iliac crest autograft or MBCP in the treatment of cervical disc disease in randomized clinical trial. A multicente randomized, comparative and prospective study on 58 patients, with a 12 months follow up are reported. They underwent anterior cervical decompression and fusion being randomized for autologous graft or MBCP. Patients presenting purely degenerative disc disease were implanted with a PEEK cage filled with iliac crest autograft or MBCP. Pain and functionality as well as patients satisfaction were assessed through VAS, Neck Disability Index (NDI) and Patient Satisfaction index were recorded until 24 month follow-up. Radiological evaluation included plain and dynamic short X-rays at each stage of the follow up. The patients satisfaction rates was of 82% in the autograft group versus 96% in the MBCP group. Pain at the donor site was significantly more important in the autograft group at 3 weeks, 3 months and 1 year follow-up. No implant failures were recorded. Previously goat preclinical study was performed. Micro CT, light microscopy and shistomorphometry were related to the high performance of the MBCP insert for filling cage fusion, completing the clinical assessment of our clinical study. The use of MBCP insert is safe and avoids potential graft site morbidity and pain in comparison with an autologous graft procedure.

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e027387 ◽  
Author(s):  
Anneli Peolsson ◽  
Gunnel Peterson ◽  
Anna Hermansen ◽  
Maria Landén Ludvigsson ◽  
Åsa Dedering ◽  
...  

IntroductionPatients suffering from remaining disability after anterior cervical decompression and fusion (ACDF) surgery for cervical disc disease may be prescribed physical activity (PPA) or neck-specific exercises (NSEs). Currently, we lack data for the success of either approach. There is also a knowledge gap concerning the use of internet-based care for cervical disc disease. The scarcity of these data, and the high proportion of patients with various degrees of incapacity following ACDF, warrant increased efforts to investigate and improve cost-effective rehabilitation. The objective is to compare the effectiveness of a structured, internet-based NSE programme, versus PPA following ACDF surgery.Methods and analysisThis is a prospective, randomised, multicentre study that includes 140 patients with remaining disability (≥30% on the Neck Disability Index, NDI) following ACDF for radiculopathy due to cervical disc disease. Patient recruitment occurs following attendance at routine clinical appointments, scheduled at 3 months postsurgery. Patients are then randomised to one of two groups (70 patients/group) for a 3-month treatment programme/period of either internet-based NSE or PPA. Questionnaires on background data, pain and discomfort, physical and mental capacity, satisfaction with care, and health and workplace factors are completed, along with physical measures of neck-related function conducted by independent test leaders blinded to randomisation. Measures are collected at inclusion, after the 3-month treatments (end of treatment) and at a 2-year follow-up. Radiography will be completed at the 2-year follow-up. Preoperative data will be collected from the Swedish Spine Registry. Data on healthcare consumption, drug use and sick leave will be requested from the relevant national registers.Ethical considerationsThis study was approved by the Regional Ethical Review Board in Linköping Ref. 2016/283–31 and 2017/91– 32. The scientists are independent with no commercial ties. Patients are recruited after providing written informed consent. Patient data are presented at group level such that no connection to any individual can be made. All data are anonymised when reported, and subject to the Swedish Official Secrets Health Acts. The test leaders are independent and blinded for randomisation. Exercises, both general and neck-specific, have been used extensively in clinical practice and we anticipate no harm from their implementation other than a risk of muscle soreness. Both randomisation groups will receive care that is expected to relieve pain, although the group receiving NSE is expected to demonstrate a greater and more cost-effective improvement versu s the PPA group. Any significant harm or unintended effects in each group will be collected by the test leaders. All questionnaires and test materials are coded by the research group, with code lists stored in locked, fireproof file cabinets, housed at the university in a room with controlled (card-based) access. Only individuals in receipt of a unique website address posted by the researchers can access the programme; patients can neither communicate with each other nor with caregivers via the programme.Study participation might lead to improved rehabilitation versus non-participation, and might therefore be of benefit. The results of this study should also contribute to more effective and flexible rehabilitation, shorter waiting times, lower costs and the possibility to implement our findings on a wider level.DisseminationIf effective, the protocols used in this study can be implemented in existing healthcare structures. The results of the study will be presented in scientific journals and popular science magazines of relevance to health. The findings will also be presented at local, regional, national and international conferences and meetings, as well as in the education of university students and at public lectures. Information about the results will be communicated to the general population in cooperation with patient organisations and the media.Trial registrationNCT03036007.


SICOT-J ◽  
2019 ◽  
Vol 5 ◽  
pp. 8 ◽  
Author(s):  
Ehab Adel El Baz ◽  
Ahmed Maher Sultan ◽  
Ahmed Samir Barakat ◽  
Wael Koptan ◽  
Yasser ElMiligui ◽  
...  

Introduction: Integrated cage and screw designs were introduced for anterior cervical discectomy and fusion (ACDF) and allegedly are superior to anterior plating due to their minimal anterior profile. Methods: A descriptive study was designed as a prospective case series of 25 patients (30 operated discs) with cervical disc disease treated with a zero-profile cage, and followed up for an average of 16 months (range 12 –18 months). Functional assessment was done with the Neck Disability Index (NDI) and Visual analog scale (VAS) scores for arm and neck pain. Furthermore, Nurick’s classification system for myelopathy based on gait abnormalities was documented. Radiological fusion was confirmed with plain X-rays and when indicated with a CT scan at 12 months postoperatively. Dysphagia was classified according to the Bazaz criteria. Results: VAS for neck and arm pain, NDI, and Nurick Score immediately improved postoperatively and remained so at 12-month follow-up. Fusion was achieved in 19 patients (95%) at six months and in 20 patients (100%) of the single-level group at one year. At six months 80% (four patients) and at 12 months 100% (five patients) showed complete union in the double-level group. No evidence of cage subsidence was noted radiographically. Discussion: The favorable lordosis and fusion rates of the low-profile integrated device are consistent with ACDF using anterior plating. Additionally, improved pain and an acceptable rate of dysphagia support the use of integrated interbody spacers for use in ACDF procedures.


2016 ◽  
Vol 92 ◽  
pp. 371-377 ◽  
Author(s):  
Benedikt W. Burkhardt ◽  
Moritz Brielmaier ◽  
Karsten Schwerdtfeger ◽  
Salman Sharif ◽  
Joachim M. Oertel

2020 ◽  
Vol 24 (2) ◽  
pp. 138-142
Author(s):  
SAJID KHAN ◽  
AKRAM ULLAH ◽  
MUSAWER KHAN ◽  
RAMZAN HUSSAIN ◽  
MUMTAZ ALI

Objective:  To assess the outcome of anterior cervical discectomy and fusion (ACDF) with PEEK cage. Material and Methods:  This prospective study was conducted in the Departments of Neurosurgery Prime Teaching Hospital and Irfan General Hospital Peshawar. Patients undergoing one level ACDF with PEEK cage fixation were enrolled in the study. Patients who needed multiple level ACDF or corpectomy with plating and redo cases were excluded from the study. A proforma, which included age, gender, address, level of prolapsed disc, sign and symptoms, pain score, MRI findings were filled. All patients were assessed on day of discharge and on follow-up visit after one month. Data was analyzed with SPSS version 22. Results:  Total 95 patients were included out of which 58 (61%) were male and 37 (39%) were female. Range of patients` Age was from 27 years to 64 years with 50.4 years mean age. Most patients (65%) had C6 radiculopathy. 58 patients (61%) had right sided radicular pain. 5 patients (5.26%) had radiculomyelopathy. C5 – C6 was the most common level operated (68 patients). Excellent results were achieved in 75 patients (79%) while satisfactory results in the rest of patients using Odom’s criteria. Bony fusion occurred in 92% of patients at 6 months. Conclusion:  ACDF with PEEK cage fixation is a safe and beneficial procedure in one level cervical prolapse disc disease


2021 ◽  
Author(s):  
Qian Du ◽  
Wei-Jun Kong ◽  
Guang-Ru Cao ◽  
Zhi-Jun Xin ◽  
Jun Ao ◽  
...  

Abstract Objective To investigate the 2-year follow-up outcomes of patients with cervical intervertebral disc herniation (CIVDH) after percutaneous full-endoscopic anterior transcorporeal cervical discectomy (PEATCD) and channel repair. Methods From Oct. 2016 to Mar. 2017, 24 patients with central/mediolateral CIVDH was treated with PEATCD and channel repair. Of the 24 cases, five interventions were performed at C3-C4 level, 11 were performed at C4-C5 level, and 8 were performed at C5-C6 level. Clinical outcomes were evaluated by Neck Disability Index (NDI), Japanese Orthopaedic Association (JOA), and Visual Analog Scale (VAS). Radiographic outcomes were measured with X-rays, computed tomography (CT) and magnetic resonance imaging.Results All the 24 procedures were completed successfully with an average operating time of 86.40±8.19min. Neck collar was advised for 3 weeks for all patients. No procedure-related complications were observed except for the swollen neck in 5 patients, which rehabilitated within 2 hours without sequela. The final scores of NDI, JOA, and VAS were improved significantly compared to those of preoperative assessments, 7.74±7.31 VS. 52.11±22.10, 16.04±0.68 VS. 9.08±1.31, and 0.52±0.65 VS. 6.73±1.45, respectively, P<0.05. Mean disc height was decreased from preoperative 5.43±0.52 mm to final 5.05±0.43 mm, without related-symptoms. No bone plug migration or channel collapse was measured during postoperative periods. All the channels were absent 12 months postoperative. Conclusion The most outstanding advantages of PEATCD with channel repair were “functional preservation” and “anatomical protection” for cervical spine, and which is a safe, feasible, effective, and minimally invasive surgery that offers an alternative for patients with CIVDH.


2007 ◽  
Vol 7 (5) ◽  
pp. 496-502 ◽  
Author(s):  
Iman Feiz-Erfan ◽  
Mary Harrigan ◽  
Volker K. H. Sonntag ◽  
Timothy R. Harrington

Object In a double-blind randomized study, platelet concentrate was used to treat 50 patients who underwent anterior cervical fusion with allograft bone and internal fixation, predominantly for degenerative disc disease or soft herniated cervical disc. The goal in this study was to compare the outcomes in patients treated with and without the platelet gel. Methods Patients were assessed radiographically at 6, 12, and 52 weeks and at 2 years if needed. Clinically, patients were evaluated with the visual analog scale, Neck Disability Index, Short Form–36, and a modified Prolo Scale. Results Follow-up included 90% of the patients at 1 year and 84% at 2 years. The overall fusion rate was 84%. Conclusions Whereas patients with degenerative discs treated with platelet gel demonstrated early fusion at the 12-week follow-up interval, no consistent early fusion was obtained with the use of the platelet gel preparation in patients with a soft disc herniation.


2004 ◽  
Vol 17 (3) ◽  
pp. 62-68 ◽  
Author(s):  
Neil Duggal ◽  
Gwynedd E. Pickett ◽  
Demytra K. Mitsis ◽  
Jana L. Keller

Object Spinal arthroplasty may become the next gold standard for the treatment of degenerative cervical spine disease. This new modality must be studied rigorously to ensure in vivo efficacy and safety. The authors review the preliminary clinical experience and radiographic outcomes following insertion of the Bryan Cervical Disc Prosthesis (Medtronic Sofamor Danek, Memphis, TN). Methods This prospective cohort study included 26 patients undergoing single- or two-level implantation of the Bryan artificial cervical disc for treatment of cervical degenerative disc disease resulting in radiculopathy and/or myelopathy. Radiographic and clinical assessments were made preoperatively 1.5, 3 months, and at 6, 12, and up to 24 months postoperatively. The Neck Disability Index (NDI) and Short Form–36 (SF-36) questionnaires were used to assess pain and functional outcomes. Segmental sagittal rotation from C2–3 to C6–7 was measured using quantitative motion analysis software. A total of 30 Bryan discs were placed in 26 patients. A single-level procedure was performed in 22 patients and a two-level procedure in the other four. Follow-up duration ranged from 1.5 to 27 months, with a mean duration of 12.3 months. A statistically significant improvement in the mean NDI scores was seen between pre- and late postoperative follow-up evaluations. A trend toward improvement in the SF-36 physical component was also found. Motion was preserved in the treated spinal segments (mean range of motion 7.8°) for up to 24 months postsurgery. The relative contribution of each segment to overall spinal sagittal rotation differed depending on whether the disc was placed at C5–6 or C6–7. Overall cervical motion (C2–7) was moderately increased on late follow-up evaluations. Conclusions The Bryan artificial cervical disc provided in vivo functional spinal motion at the treated level. Overall cervical spinal motion was not significantly altered. Sagittal rotation did not change significantly at any level after surgery.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Ce Zhu ◽  
Miaomiao He ◽  
Lili Mao ◽  
Tao Li ◽  
Li Zhang ◽  
...  

Abstract Background Currently, there are limited reports regarding investigation of the biological properties of polyetheretherketone (PEEK) coated with titanium (Ti) and hydroxyapatite (HA) in human. The objective of this study is to evaluate the in vivo response of the PEEK cages coated with Ti and HA versus uncoated PEEK cages after anterior cervical discectomy and fusion (ACDF) in patients with single-level cervical degenerative disc disease (CDDD). Methods Twenty-four patients with PEEK cages coated with Ti and HA (PEEK/Ti/HA group) were matched one-to-one with patients with uncoated PEEK cages (PEEK group) based on age, gender, and operative segment. All patients had been followed up for more than 2 years. Radiological assessments included intervertebral height (IH), C2-7 angle (C2-7a), segmental alignment (SA), and fusion rate. Clinical parameters included Visual Analogue Scale (VAS) and Japanese Orthopedic Association (JOA) scores. Results There was no statistical difference in SA, IH, and C2-7a between the two groups before and after surgery and all these parameters were restored postoperatively. The fusion rate of PEEK/Ti/HA group was significantly higher than PEEK group at 3-month post-operation (87.5% vs. 62.5%). At the last follow-up, the fusion rate of the both groups achieved 100%. The VAS and JOA scores were comparable between two groups and improved postoperatively. Conclusions In patients with single-level ACDF, PEEK cage coated with Ti and HA provided a higher fusion rate than uncoated PEEK cage at 3-month post-operation, while both two cages could achieve solid osseous fusion at the last follow up. Compared with the uncoated PEEK cage, PEEK/Ti/HA cage yielded similar favorable segmental and overall cervical lordosis, IH, and clinical outcomes after the surgery.


2017 ◽  
Vol 42 (2) ◽  
pp. E5 ◽  
Author(s):  
Deshpande V. Rajakumar ◽  
Akshay Hari ◽  
Murali Krishna ◽  
Subhas Konar ◽  
Ankit Sharma

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.


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