scholarly journals Frisbee - the first artificial cervical disc of 3RD generation

2014 ◽  
Vol 13 (1) ◽  
pp. 43-48
Author(s):  
Karin Büttner-Janz ◽  
Bernhard Meyer ◽  
Rafael Donatus Sambale ◽  
Hans-Joachim Wilke ◽  
Nelli Rüdiger ◽  
...  

OBJECTIVE: The current cervical disc arthroplasty is limited by postoperative facet joint arthritis, heterotopic ossification and segmental kyphosis. The total Frisbee disc, which has an upper convex/concave non-spherical surface and a lower flat sliding surface, is a new approach for improved outcomes. Prior to clinical application, safety and suitability tests are required. METHODS: The Frisbee is the first 3rd generation disc according to a new classification of total disc because it can precisely mimic the segmental ROM, including the soft limitation of axial rotation. The ISO 18192-1 test was carried out to determine the rate of wear debris. A FE model was used to assess the safety of prosthetic components. In the sagittal plane several variables to determine the most favorable lordotic angle were evaluated. RESULTS: Two angled prosthetic plates are safer than one sliding angled core to prevent the displacement. The lordosis of 7° of the Frisbee leads to kyphosis of no more than 2° without reduction of the ROM. The wear rate of the Frisbee is five times smaller compared to an FDA-approved disc with a spherical sliding surface. CONCLUSIONS: Based on the test results, the clinical application of Frisbee can now be studied. The postoperative kyphosis observed with other devices is not an issue with the Frisbee design. Physiological ROM is combined with the significant reduction of wear debris. For these reasons the Frisbee has the potential to provide a better balanced segmental loading reducing the degeneration of the joint surface and heterotopic ossification.

2020 ◽  
Vol 20 (9) ◽  
pp. S123-S124
Author(s):  
Matthew F. Gornet ◽  
Todd H. Lanman ◽  
J. Kenneth Burkus ◽  
Randall F. Dryer ◽  
Jeffrey R. McConnell ◽  
...  

2016 ◽  
Vol 24 (5) ◽  
pp. 752-759 ◽  
Author(s):  
Peng-Yuan Chang ◽  
Hsuan-Kan Chang ◽  
Jau-Ching Wu ◽  
Wen-Cheng Huang ◽  
Li-Yu Fay ◽  
...  

OBJECTIVE Several large-scale clinical trials demonstrate the efficacy of 1- and 2-level cervical disc arthroplasty (CDA) for degenerative disc disease (DDD) in the subaxial cervical spine, while other studies reveal that during physiological neck flexion, the C4–5 and C5–6 discs account for more motion than the C3–4 level, causing more DDD. This study aimed to compare the results of CDA at different levels. METHODS After a review of the medical records, 94 consecutive patients who underwent single-level CDA were divided into the C3–4 and non-C3–4 CDA groups (i.e., those including C4–5, C5–6, and C6–7). Clinical outcomes were measured using the visual analog scale for neck and arm pain and by the Japanese Orthopaedic Association scores. Postoperative range of motion (ROM) and heterotopic ossification (HO) were determined by radiography and CT, respectively. RESULTS Eighty-eight patients (93.6%; mean age 45.62 ± 10.91 years), including 41 (46.6%) female patients, underwent a mean follow-up of 4.90 ± 1.13 years. There were 11 patients in the C3–4 CDA group and 77 in the non-C3–4 CDA group. Both groups had significantly improved clinical outcomes at each time point after the surgery. The mean preoperative (7.75° vs 7.03°; p = 0.58) and postoperative (8.18° vs 8.45°; p = 0.59) ROMs were similar in both groups. The C3–4 CDA group had significantly greater prevalence (90.9% vs 58.44%; p = 0.02) and higher severity grades (2.27 ± 0.3 vs 0.97 ± 0.99; p = 0.0001) of HO. CONCLUSIONS Although CDA at C3–4 was infrequent, the improved clinical outcomes of CDA were similar at C3–4 to that in the other subaxial levels of the cervical spine at the approximately 5-year follow-ups. In this Asian population, who had a propensity to have ossification of the posterior longitudinal ligament, there was more HO formation in patients who received CDA at the C3–4 level than in other subaxial levels of the cervical spine. While the type of artificial discs could have confounded the issue, future studies with more patients are required to corroborate the phenomenon.


2010 ◽  
Vol 1 (01) ◽  
pp. 15-20 ◽  
Author(s):  
Giuseppe Barbagallo ◽  
Leonardo Corbino ◽  
Giuseppe Olindo ◽  
Vincenzo Albanese

Spine ◽  
2019 ◽  
Vol 44 (9) ◽  
pp. 624-628 ◽  
Author(s):  
Junfeng Zeng ◽  
Hao Liu ◽  
Hua Chen ◽  
Xin Rong ◽  
Yang Meng ◽  
...  

2019 ◽  
Author(s):  
Guo Yingjun ◽  
Chen Jiali ◽  
Hao Liu ◽  
Meng Yang ◽  
Ding Chen ◽  
...  

Abstract Background: Heterotopic ossification has become a common disease after CDA, which has attracted much attention. Understanding the law of its occurrence and development can provide theoretical basis for the formulation of HO prevention strategies. To acquire the objective data and the change rule of HO incidence, a meta-analysis of all available evidence was performed. Methods: A search of the literature was conducted on Pubmed/MEDLINE, EMBASE, and Web of Science. Relevant studies including incidence-relative data of HO were selected according to eligibility criteria. Results: 52 studies were eligible and finally included and the quality assessment showed a relative high score of them. The results of the analysis reminded us that the incidence of HO increased with the extension of follow-up time, both based on the number of cases and the number of segments, and the increase mainly occurred after 6 years. Grade III-IV HO showed us a positive correlation with follow-up time (R2=0.218), while Grade I-II HO did not change a lot in different follow-up time points. Conclusions: The follow-up time after CDA should be long enough, so as to ensure the true clinical results. HO occurs all the postoperative time and Grade I-II HO will gradually develop into Grade III-IV, while continuous new HO keeps the number of Grade I-II in a dynamic balance. Through this study, we can preliminarily define the relatively objective incidence and change rule of HO, which provides data basis and theoretical basis for the future research of HO prevention strategy.


2019 ◽  
Vol 28 (10) ◽  
pp. 2359-2370 ◽  
Author(s):  
Lingyun Hu ◽  
Jianying Zhang ◽  
Hao Liu ◽  
Yang Meng ◽  
Yi Yang ◽  
...  

2020 ◽  
Vol 33 (1) ◽  
pp. 41-50
Author(s):  
Matthew F. Gornet ◽  
Todd H. Lanman ◽  
J. Kenneth Burkus ◽  
Randall F. Dryer ◽  
Jeffrey R. McConnell ◽  
...  

OBJECTIVEThe authors sought to assess the impact of heterotopic ossification (HO) on clinical outcomes and angular range of motion (ROM) after cervical disc arthroplasty (CDA) performed with the Prestige LP Cervical Disc (Prestige LP disc) at 2 levels.METHODSHO was assessed and graded from 0 to IV for increasing severity on lateral neutral radiographs at each visit in 209 patients who underwent implantation of Prestige LP discs at 2 cervical levels in a clinical trial with extended 10-year follow-up. ROM was compared by using HO grade, and clinical outcomes were compared between HO subgroups (grade 0–II vs III/IV) based on HO severity at 2 and 10 years after surgery.RESULTSThe grade III/IV HO incidence at either or both index levels was 24.2% (48/198) at 2 years and 39.0% (57/146) at 10 years. No statistical difference was found in overall success; neurological success; or Neck Disability Index (NDI), neck pain, arm pain, or SF-36 Physical Component Summary (PCS) scores between the HO subgroups (grade 0–II vs III/IV) at either 2 or 10 years. The cumulative rate of possible implant-related adverse events (AEs) was higher in patients having grade III/IV HO at 2 years (56.3%) and 10 years (47.8%) compared with those having grade 0–II HO at 2 years (24.4%) and 10 years (17.9%), specifically in 2 subcategories: spinal events and HOs reported by the investigators. No statistical difference was found between the HO subgroups in possible implant-related serious AEs or secondary surgeries at the index or adjacent levels. The average angular ROMs at index levels were lower in subjects with higher-grade HO at 2 and 10 years. The average ROMs at the superior level were 8.8°, 6.6°, 3.2°, and 0.3°, respectively, for the HO grade 0/I, II, III, and IV groups at 10 years, and 7.9°, 6.2°, 3.7°, and 0.6°, respectively, at the inferior level.CONCLUSIONSRadiographically severe (grade III or IV) HO after CDA with the Prestige LP disc at 2 levels did not significantly affect efficacy or safety outcomes (severe AEs or secondary surgeries). However, severe HO, particularly grade IV HO, significantly limited ROM, as expected.


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