scholarly journals Early clinical and biomechanical results following cervical arthroplasty

2004 ◽  
Vol 17 (3) ◽  
pp. 62-68 ◽  
Author(s):  
Neil Duggal ◽  
Gwynedd E. Pickett ◽  
Demytra K. Mitsis ◽  
Jana L. Keller
Keyword(s):  
Short Form ◽  
Neck Disability Index ◽  
Cervical Disc ◽  
Disc Disease ◽  
Cervical Arthroplasty ◽  
Spinal Motion ◽  
Sf 36 ◽  
Cervical Disc Prosthesis

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.

Solid radiographic fusion with a nonconstrained device 5 years after cervical arthroplasty

2014 ◽  
Vol 21 (6) ◽  
pp. 951-955 ◽  
Author(s):  
Robert F. Heary ◽  
Ira M. Goldstein ◽  
Katarzyna M. Getto ◽  
Nitin Agarwal
Keyword(s):  
Short Form ◽  
Total Disc Replacement ◽  
Neck Disability Index ◽  
Dynamic Imaging ◽  
Cervical Disc ◽  
First Case ◽  
Sf 36 ◽  
Index Site ◽  
Functional Scores

Cervical disc arthroplasty (CDA) has been gaining popularity as a surgical alternative to anterior cervical discectomy and fusion. Spontaneous fusion following a CDA is uncommon. A few anecdotal reports of heterotrophic ossification around the implant sites have been noted for the BRYAN, ProDisc-C, Mobi-C, PRESTIGE, and PCM devices. All CDA fusions reported to date have been in devices that are semiconstrained. The authors reported the case of a 56-year-old man who presented with left C-7 radiculopathy and neck pain for 10 weeks after an assault injury. There was evidence of disc herniation at the C6–7 level. He was otherwise healthy with functional scores on the visual analog scale (VAS, 4.2); neck disability index (NDI, 16); and the 36-item short form health survey (SF-36; physical component summary [PSC] score 43 and mental component summary [MCS] score 47). The patient underwent total disc replacement in which the DISCOVER Artificial Cervical Disc (DePuy Spine, Inc.) was used. The patient was seen at regular follow-up visits up to 60 months. At his 60-month follow-up visit, he had complete radiographic fusion at the C6–7 level with bridging trabecular bone and no motion at the index site on dynamic imaging. He was pain free, with a VAS score of 0, NDI score of 0, and SF-36 PCS and MCS scores of 61 and 55, respectively. Conclusions This is the first case report that identifies the phenomenon of fusion around a nonconstrained cervical prosthesis. Despite this unwanted radiographic outcome, the patient's clinical outcome was excellent.

scholarly journals Effects of a cervical disc prosthesis on segmental and cervical spine alignment

2004 ◽  
Vol 17 (3) ◽  
pp. 1-35 ◽  
Author(s):  
Gwynedd E. Pickett ◽  
Demytra K. Mitsis ◽  
Lali H. Sekhon ◽  
William R. Sears ◽  
Neil Duggal
Keyword(s):  
Cervical Spine ◽  
Clinical Outcomes ◽  
Sagittal Balance ◽  
Cervical Disc ◽  
Disc Prosthesis ◽  
Disc Space ◽  
Cervical Arthroplasty ◽  
Sf 36 ◽  
Cervical Disc Prosthesis

Object Cervical arthroplasty offers the promise of maintaining motion of the functional spinal unit (FSU) after anterior cervical discectomy. The impact of cervical arthroplasty on sagittal alignment of the FSU needs to be addressed, together with its effect on overall sagittal balance of the cervical spine. Methods The authors prospectively reviewed radiographic and clinical outcomes in 14 patients who received the Bryan Cervical Disc prosthesis (Medtronic Sofamor Danek, Memphis, TN), for whom early (< 6 months) and late (6–24 months) follow-up data were available. Static and dynamic radiographs were measured by hand and computer to determine the angles formed by the endplates of the natural disc preoperatively, those formed by the shells of the implanted prosthesis, the angle of the FSU, and the C2–7 Cobb angle. The range of motion (ROM) was also determined radiographically, whereas clinical outcomes were assessed using the Neck Disability Index (NDI), and Short Form–36 (SF-36) questionnaires. The ROM was preserved following surgery, with a mean preoperative sagittal rotation angle of 8.96°, which was not significantly different from the late postoperative value of 8.25°. When compared with the preoperative disc space angle, the shell endplate angle in the neutral position became kyphotic in the early and late postoperative periods (mean change −3.8° in the late follow-up period; p = 0.0035). The FSU angles also became significantly more kyphotic post-operatively, with a mean change of −6° (p = 0.0006). The Cobb angles varied widely preoperatively and did not change significantly after surgery. There was no statistical correlation between the NDI and SF-36 outcomes and cervical kyphosis. Conclusions Cervical arthroplasty preserves motion of the FSU. Both the endplate angle of the treated disc space and the angle of the FSU became kyphotic after insertion of the Bryan prosthesis. The overall sagittal balance of the cervical spine, however, was preserved.

Effect of autologous platelet gel on early and late graft fusion in anterior cervical spine surgery

2007 ◽  
Vol 7 (5) ◽  
pp. 496-502 ◽  
Author(s):  
Iman Feiz-Erfan ◽  
Mary Harrigan ◽  
Volker K. H. Sonntag ◽  
Timothy R. Harrington
Keyword(s):  
Short Form ◽  
Randomized Study ◽  
Neck Disability Index ◽  
Cervical Disc ◽  
Disc Disease ◽  
Platelet Gel ◽  
Double Blind ◽  
Cervical Spine Surgery ◽  
Early Fusion

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.

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 Physiotherapy after anterior cervical spine surgery for cervical disc disease: study protocol of a prospective randomised study to compare internet-based neck-specific exercise with prescribed physical activity

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e027387 ◽  
Author(s):  
Anneli Peolsson ◽  
Gunnel Peterson ◽  
Anna Hermansen ◽  
Maria Landén Ludvigsson ◽  
Åsa Dedering ◽  
...  
Keyword(s):  
Physical Activity ◽  
Disease Patient ◽  
Neck Disability Index ◽  
Cost Effective ◽  
Popular Science ◽  
Cervical Disc ◽  
Ethical Review ◽  
Cervical Disc Disease ◽  
Disc Disease

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.

Prospective study of cervical arthroplasty in 98 patients involved in 1 of 3 separate investigational device exemption studies from a single investigational site with a minimum 2-year follow-up

2010 ◽  
Vol 13 (6) ◽  
pp. 715-721 ◽  
Author(s):  
Domagoj Coric ◽  
Joseph Cassis ◽  
John D. Carew ◽  
Margaret O. Boltes
Keyword(s):  
Clinical Outcomes ◽  
Clinical Success ◽  
Total Disc Replacement ◽  
Neck Disability Index ◽  
Self Report ◽  
Cervical Disc ◽  
Adjacent Level ◽  
Cervical Arthroplasty ◽  
Investigational Device Exemption

Object Cervical total disc replacement (TDR) was developed to address some of the shortcomings associated with anterior cervical discectomy and fusion (ACDF) by preserving motion at the treated level. To establish an evidence-based rationale for cervical TDR to serve as a viable alternative to ACDF, cervical arthroplasty must establish equivalent or superior clinical outcomes while maintaining motion. The authors report on 98 patients from a single investigational site involved in 3 separate prospective, randomized, controlled investigational device exemption multicenter trials comparing cervical arthroplasty to ACDF with a 2–6-year follow-up. Methods Patients with 1- and 2-level cervical disc disease producing radiculopathy and/or myelopathy were randomized prospectively under 3 separate investigational device exemption pivotal trials to undergo ACDF with plate or artificial disc placement. The 3 arthroplasty systems evaluated were the Bryan cervical disc, Kineflex/C disc, and Discover cervical disc. The patients were evaluated with pre- and postoperative serial neurological examinations, radiographs, and clinical outcome indices at 1, 3, 6, 12, 24, 36, 48, and 60 months. Results Ninety-eight patients were treated at the authors' single investigational site. Fifty-seven of these patients underwent cervical arthroplasty and 41 underwent ACDF. A minimum 24-month follow-up was available for 90 patients (92%; 53 in the combined arthroplasty group and 37 in the combined ACDF group) with a follow-up duration ranging from 24 to 67 months (mean 38 months). Clinical success, defined as a composite measure consisting of 5 separate components, was significantly higher in the combined arthroplasty group (85%) compared with the combined ACDF group (70%; p = 0.035). The Neck Disability Index and visual analog scale patient self-report measures were evaluated at 3–24-months follow-up, and all groups showed excellent clinical outcomes. All groups (Bryan, Kineflex/C, Discover, and ACDF) showed statistically significant improvement from the preoperative period to a minimum 2-year follow-up (p < 0.0001). Overall, angular motion was improved by 0.91° in the combined arthroplasty group and reduced by 7.8° in the combined ACDF group (p < 0.0001). In the ACDF group there was a fusion rate of 97% (36 of 37 cases). In the arthroplasty group there was a 5.6% incidence of bridging heterotopic ossification (3 cases). There were a total of 4 reoperations (7.5%) in the combined arthroplasty group with 1 (1.9%) at the adjacent level. There were 3 reoperations (8.1%) in the ACDF group, all at the adjacent level. Conclusions The prospective, intermediate-term (average follow-up > 3 years) results of cervical TDR at the authors' site are encouraging. Patients treated with the artificial discs showed significantly better clinical results, maintained motion at the treated level, and trended toward less adjacent-level disease.

Ten-Year Outcomes of 1- and 2-Level Cervical Disc Arthroplasty From the Mobi-C Investigational Device Exemption Clinical Trial

Neurosurgery ◽  
2020 ◽  
Author(s):  
Kee Kim ◽  
Greg Hoffman ◽  
Hyun Bae ◽  
Andy Redmond ◽  
Michael Hisey ◽  
...  
Keyword(s):  
Neck Disability Index ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Adjacent Segment ◽  
Disc Disease ◽  
Cervical Arthroplasty ◽  
Disc Arthroplasty ◽  
Arm Pain ◽  
Pain Outcomes ◽  
Neck Disability

Abstract BACKGROUND Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration. OBJECTIVE To report the 10-yr outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology. METHODS This was a prospective study of patients treated with CDA at 1 or 2 contiguous levels using the Mobi-C® Cervical Disc (Zimmer Biomet). Following completion of the 7-yr Food and Drug Administration postapproval study, follow-up continued to 10 yr for consenting patients at 9 high-enrolling centers. Clinical and radiographic endpoints were collected out to 10 yr. RESULTS At 10 yr, patients continued to have significant improvement over baseline Neck Disability Index (NDI), neck and arm pain, neurologic function, and segmental range of motion (ROM). NDI and pain outcomes at 10 yr were significantly improved from 7 yr. Segmental and global ROM and sagittal alignment also were maintained from 7 to 10 yr. Clinically relevant adjacent segment pathology was not significantly different between 7 and 10 yr. The incidence of motion restricting heterotopic ossification at 10 yr was not significantly different from 7 yr for 1-level (30.7% vs 29.6%) or 2-level (41.7% vs 39.2%) patients. Only 2 subsequent surgeries were reported after 7 yr. CONCLUSION Our results through 10 yr were comparable to 7-yr outcomes, demonstrating that CDA with Mobi-C continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease.

scholarly journals Cervical disc prosthesis: 2-year follow-up

2015 ◽  
Vol 14 (2) ◽  
pp. 85-87
Author(s):  
Romero Pinto de Oliveira Bilhar ◽  
Alexandre Fogaça Cristante ◽  
Raphael Martus Marcon ◽  
Ivan Dias da Rocha ◽  
Olavo Biraghi Letaif ◽  
...  
Keyword(s):  
Medical Records ◽  
Epidemiological Data ◽  
Cervical Disc ◽  
Safe Procedure ◽  
Disc Prosthesis ◽  
Cervical Arthroplasty ◽  
Cervical Disc Prosthesis ◽  
The Mean

<sec><title>OBJECTIVE:</title><p> To review the medical records of patients who underwent surgery for placement of cervical disc prosthesis after two years of postoperative follow-up, showing the basic epidemiological data, the technical aspects and the incidence of complications.</p></sec><sec><title>METHODS:</title><p> Medical records of seven patients who underwent surgery for placement of cervical disc prosthesis were reviewed after two years of follow-up, at the Institute of Orthopedics and Traumatology, Faculty of Medicine, University of São Paulo.</p></sec><sec><title>RESULTS:</title><p> The average age of patients participating in this study was 43.86 years. Six patients (85.7%) had one level approached while one patient (14.3%) had two levels addressed. The level C5-C6 has been approached in one patient (14.3%) while the C6-C7 level was addressed in five patients (71.4%). One patient (14.3%) had these two levels being addressed, C5-C6 and C6-C7. The mean operative time was 164.29±40 minutes. Three patients were hospitalized for 2 days and four for 3 days making an average of 2.57±0.535 days. Two patients (28.6%) underwent a new surgical intervention due to loosening of the prosthesis. The mean follow-up was 28.14±5.178 months (23-35 months).</p></sec><sec><title>CONCLUSIONS:</title><p> Although cervical arthroplasty appears to be a safe procedure and present promising results in our study as well as in many other studies, it requires long-term studies.</p></sec>

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