scholarly journals Cervical arthroplasty: what does the labeling say?

2017 ◽  
Vol 42 (2) ◽  
pp. E2 ◽  
Author(s):  
Mazda K. Turel ◽  
Mena G. Kerolus ◽  
Owoicho Adogwa ◽  
Vincent C. Traynelis
Keyword(s):  
Outcome Measures ◽  
Revision Surgery ◽  
Controlled Trial ◽  
Neck Disability Index ◽  
Specific Treatment ◽  
The United States ◽  
Cervical Disc ◽  
Cervical Arthroplasty ◽  
Single Level ◽  
Level Group

OBJECTIVE The aim of this paper was to comprehensively review each of the Food and Drug Administration (FDA)–approved labels of 7 total cervical disc replacements, assess the exact methodology in which the trial was conducted, and provide a broad comparison of these devices to allow each surgeon to determine which disc best suits his or her specific treatment goals based on the specific labels and not the studies published. METHODS The FDA-approved labels for each of the 7 artificial discs were obtained from the official FDA website. These labels were meticulously compared with regard to the statistical analysis performed, the safety and efficacy data, and the randomized controlled trial that each artificial disc was involved in to obtain the FDA approval for the product or device. Both single-level and 2-level approvals were examined, and primary and secondary end points were assessed. RESULTS In the single-level group, 4 of the 7 artificial discs—Prestige LP, Prestige ST, Bryan, and Secure-C—showed superiority in overall success. Prestige ST showed superiority in 3 of 4 outcome measures (neurological success, revision surgery, and overall success), while the other aforementioned discs showed superiority in 2 or fewer measures (Prestige LP, neurological and overall success; Bryan, Neck Disability Index [NDI] and overall success; Secure-C, revision surgery and overall success; Pro-Disc C, revision surgery). The PCM and Mobi-C discs demonstrated noninferiority across all outcome measures. In the 2-level group, Prestige LP and Mobi-C demonstrated superiority in 3 outcome measures (NDI, secondary surgery, and overall success) but not neurological success. CONCLUSIONS This paper provides a comprehensive analysis of 7 currently approved and distributed artificial discs in the United States. It compares specific outcome measures of these devices against those following the standard of care, which is anterior cervical discectomy and fusion. This information will provide surgeons the opportunity to easily answer patients' questions and remain knowledgeable when discussing devices with manufacturers.

Differences between soft-disc herniation and spondylosis in cervical arthroplasty: CT-documented heterotopic ossification with minimum 2 years of follow-up

2012 ◽  
Vol 16 (2) ◽  
pp. 163-171 ◽  
Author(s):  
Jau-Ching Wu ◽  
Wen-Cheng Huang ◽  
Tsung-Hsi Tu ◽  
Hsiao-Wen Tsai ◽  
Chin-Chu Ko ◽  
...  
Keyword(s):  
Heterotopic Ossification ◽  
Clinical Outcomes ◽  
Disc Herniation ◽  
Cervical Disc ◽  
Artificial Disc ◽  
Cervical Arthroplasty ◽  
Single Level ◽  
Arm Pain ◽  
Estimated Blood Loss

Object Cervical arthroplasty is a valid option for patients with single-level symptomatic cervical disc diseases causing neural tissue compression, but postoperative heterotopic ossification (HO) can limit the mobility of an artificial disc. In the present study the authors used CT scanning to assess HO formation, and they investigated differences in radiological and clinical outcomes in patients with either a soft-disc herniation or spondylosis who underwent cervical arthroplasty. Methods Medical records, radiographs, and clinical evaluations of consecutive patients who underwent single-level cervical arthroplasty were reviewed. Arthroplasty was performed using the Bryan disc. The patients were divided into a soft-disc herniation group and a spondylosis group. Clinical outcomes were measured using the visual analog scale (VAS) for neck and arm pain and the Neck Disability Index (NDI), whereas HO grading was determined by studying CT scans. Radiological and clinical outcomes were analyzed, and the minimum follow-up duration was 24 months. Results Forty-seven consecutive patients underwent a single-level cervical arthroplasty. Forty patients (85.1%) had complete radiological evaluations and clinical follow-up of more than 2 years. Patients were divided into 1 of 2 groups: soft-disc herniation (16 cases) and the spondylosis group (24 cases). Their mean age was 45.51 ± 11.12 years. Sixteen patients (40%) were female. Patients in the soft-disc herniation group were younger than those in the spondylosis group, but the difference was not statistically significant (42.88 vs 47.26, p = 0.227). The mean follow-up duration was 38.83 ± 9.74 months. Sex, estimated blood loss, implant size, and perioperative NSAID prescription were not significantly different between the groups (p = 0.792, 0.267, 0.581, and 1.000, respectively). The soft-disc herniation group had significantly less HO formation than the spondylosis group (1 HO [6.25%] vs 14 Hos [58.33%], p = 0.001). Almost all artificial discs in both groups remained mobile (100% and 95.8%, p = 0.408). The clinical outcomes were not significantly different between the groups at all postoperative time points of evaluation, and clinical improvements were also similar. Conclusions Clinical outcomes of single-level cervical arthroplasty for soft-disc herniation and spondylosis were similar 3 years after surgery. There was a significantly higher rate of HO formation in patients with spondylosis than in those with a soft-disc herniation. The mobility of the artificial disc is maintained, but the long-term effects of HO and its higher frequency in spondylotic cases warrant further investigation.

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 Multilevel cervical arthroplasty: current evidence. A systematic review

2017 ◽  
Vol 42 (2) ◽  
pp. E4 ◽  
Author(s):  
Andrei F. Joaquim ◽  
K. Daniel Riew
Keyword(s):  
Systematic Review ◽  
Clinical Studies ◽  
Case Reports ◽  
Current Evidence ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Cervical Arthroplasty ◽  
Study Objective ◽  
Single Level ◽  
Cervical Surgery

OBJECTIVE Cervical disc arthroplasty (CDA) has been demonstrated to be an effective treatment modality for single-level cervical radiculopathy or myelopathy. Its advantages over an anterior cervical discectomy and fusion (ACDF) include motion preservation and decreased reoperations at the index and adjacent segments up to 7 years postoperatively. Considering the fact that many patients have multilevel cervical disc degeneration (CDD), the authors performed a systematic review of the clinical studies evaluating patients who underwent multilevel CDA (2 or more levels). METHODS A systematic review in the MEDLINE database was performed. Clinical studies including patients who had multilevel CDA were selected and included. Case reports and literature reviews were excluded. Articles were then grouped according to their main study objective: 1) studies comparing multilevel CDA versus ACDF; 2) studies comparing single-level CDA versus multilevel CDA; and 3) multilevel CDA after a previous cervical spine surgery. RESULTS Fourteen articles met all inclusion criteria. The general conclusions were that multilevel CDA was at least as safe and effective as ACDF, with preservation of cervical motion when compared with ACDF and potentially with fewer reoperations expected in most of the studies. Multilevel CDAs are clinically effective as single-level surgeries, with good clinical and radiological outcomes. Some studies reported a higher incidence of heterotopic ossification in multilevel CDA when compared with single-level procedures, but without clinical relevance during the follow-up period. A CDA may be indicated even after a previous cervical surgery in selected cases. CONCLUSIONS The current literature supports the use of multilevel CDA. Caution is necessary regarding the more restrictive indications for CDA when compared with ACDF. Further prospective, controlled, multicenter, and randomized studies not sponsored by the device manufactures are desirable to prove the superiority of CDA surgery over ACDF as the treatment of choice for CDD in selected cases.

scholarly journals The use of anterior cervical interbody spacer with integrated fixation screws for management of cervical disc disease

SICOT-J ◽  
2019 ◽  
Vol 5 ◽  
pp. 8 ◽  
Author(s):  
Ehab Adel El Baz ◽  
Ahmed Maher Sultan ◽  
Ahmed Samir Barakat ◽  
Wael Koptan ◽  
Yasser ElMiligui ◽  
...  
Keyword(s):  
Neck Disability Index ◽  
Case Series ◽  
Cervical Disc ◽  
X Rays ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Arm Pain ◽  
Cage Subsidence ◽  
Anterior Plating ◽  
Level Group

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.

scholarly journals Determining the Optimal Outcome Measures for Studying the Social Determinants of Health

2020 ◽  
Vol 17 (9) ◽  
pp. 3028
Author(s):  
Peter Muennig ◽  
Bruce McEwen ◽  
Daniel W. Belsky ◽  
Kimberly G. Noble ◽  
James Riccio ◽  
...  
Keyword(s):  
Health Outcomes ◽  
Conceptual Model ◽  
Outcome Measures ◽  
Healthy Aging ◽  
Controlled Trial ◽  
The United States ◽  
Time Frame ◽  
Optimal Time ◽  
Workforce Policy

Americans have significantly poorer health outcomes and shorter longevity than citizens of other industrialized nations. Poverty is a major driver of these poor health outcomes in the United States. Innovative anti-poverty policies may help reduce economic malaise thereby increasing the health and longevity of the most vulnerable Americans. However, there is no consensus framework for studying the health impacts of anti-poverty social policies. In this paper, we describe a case study in which leading global experts systematically: (1) developed a conceptual model that outlines the potential pathways through which a social policy influences health, (2) fits outcome measures to this conceptual model, and (3) estimates an optimal time frame for collection of the selected outcome measures. This systematic process, called the Delphi method, has the potential to produce estimates more quickly and with less bias than might be achieved through expert panel discussions alone. Our case study is a multi-component randomized-controlled trial (RCT) of a workforce policy called MyGoals for Healthy Aging.

scholarly journals A Prospective Study of Clinical and Radiological Outcomes of Zero-Profile Cage Screw Implants for Single-Level Anterior Cervical Discectomy and Fusion: Is Segmental Lordosis Maintained at 2 Years?

2017 ◽  
Vol 11 (2) ◽  
pp. 264-271 ◽  
Author(s):  
Saumyajit Basu ◽  
Sreeramalingam Rathinavelu
Keyword(s):  
Neck Disability Index ◽  
Disc Height ◽  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Adjacent Segment ◽  
Cervical Lordosis ◽  
Cervical Discectomy ◽  
Single Level ◽  
Adjacent Disc ◽  
Segmental Lordosis

<sec><title>Study Design</title><p>Prospective cohort study.</p></sec><sec><title>Purpose</title><p>To study clinicoradiological parameters of zero-profile cage screw used for anterior cervical discectomy and fusion (ACDF).</p></sec><sec><title>Overview of Literature</title><p>Radiological parameters of various implants used for ACDF are available, but those for zero-profile cage are sparse.</p></sec><sec><title>Methods</title><p>Patients with unilateral intractable brachialgia due to single-level cervical disc prolapse between April 1, 2011 and March 31, 2014 were included. Clinical assessment included arm and neck pain using visual analogue score (VAS) and neck disability index (NDI) scores. Radiological assessment included motion segment height, adjacent disc height (upper and lower), segmental and cervical lordosis, implant subsidence, and pseudoarthrosis. Follow-ups were scheduled at 1, 3, 6, 12, and 24 months.</p></sec><sec><title>Results</title><p>Thirty-four patients (26 males, 8 females) aged 30–50 years (mean, 42.2) showed excellent clinical improvement based on VAS scores (7.4–0 for arm and 2.0–0.6 for neck pains). Postoperative disc height improved by 11.33% (<italic>p</italic>&lt;0.001), but at 2 years, the score deteriorated by 7.03% (<italic>p</italic>&lt;0.001). Difference in the adjacent segment disc height at 2 years was 0.08% (<italic>p</italic>=0.8) in upper and 0.16% (<italic>p</italic>&lt;0.001) in lower disc spaces. Average segmental lordosis achieved was 5.59° (<italic>p</italic>&lt;0.001) from a preoperative kyphosis of 0.88°; at 2 years, an average loss of 7.05° (<italic>p</italic>&lt;0.001) occurred, resulting in an average segmental kyphosis of 1.38°. Cervical lordosis improved from 11.59° to 14.88° (<italic>p</italic>=0.164), and at 2 years, it progressively improved to 22.59° (<italic>p</italic>&lt;0.001). Three patients showed bone formation and two mild protrusion of the implant at 2 years without pseudoarthrosis/implant failure.</p></sec><sec><title>Conclusions</title><p>The zero-profile cage screw device provides good fusion and cervical lordosis but is incapable of maintaining the segmental lordosis achieved up to a 2-year follow-up. We also recommend caution when using it in patients with small vertebrae.</p></sec>

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