scholarly journals Mechanical Stability of the Prodisc-C Vivo Cervical Disc Arthroplasty: A Preliminary, Observational Study Using Radiostereometric Analysis

2019 ◽  
Vol 10 (3) ◽  
pp. 294-302
Author(s):  
Miranda L. van Hooff ◽  
Petra J. C. Heesterbeek ◽  
Maarten Spruit
Keyword(s):  
Adverse Events ◽  
Clinical Outcomes ◽  
Small Sample ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Radiostereometric Analysis ◽  
Disc Arthroplasty ◽  
Arm Pain ◽  
Flexion Extension ◽  
Over Time

Study Design: Prospective cohort study. Objective: To investigate the primary stability of the Prodisc-C Vivo cervical disc arthroplasty with regard to the adjacent cervical vertebrae using radiostereometric analysis (RSA), and to monitor its clinical performance. Methods: Sixteen patients with degenerative cervical disc disease were included. RSA radiographs were obtained at the first postoperative day, at 6 weeks, 3 months, and 6 months postoperatively. Migration (translation [mm]) of the superior and inferior implant components were measured with model-based RSA, expressed along the 3 orthogonal axes, and calculated as total translation. Clinical outcomes were Neck Disability Index, numeric rating scales for neck and arm pain, Likert-type scales for satisfaction, and adverse events. Range of motion was reported as C2-C7 flexion-extension mobility (ROM). Results: At final follow-up, no significant increase over time in median total translation was found. One inferior and 3 superior components subsided but were asymptomatic. ROM remained stable and clinical outcomes improved over time. Although 3 patients were unsatisfied and 3 adverse events occurred, this was not related to translation of the components. Conclusions: On a group level, both components of the Prodisc-C Vivo cervical disc arthroplasty remained stable over time and below the clinical threshold of 1 mm. Individual outliers for translation were not clinically relevant and probably related to settling of the components into the vertebral endplates. RSA allowed us to perform a preliminary but accurate study on the micromotion of a new cervical disc replacement in a small sample size, without putting large numbers of patients at risk.

scholarly journals Differences between C3–4 and other subaxial levels of cervical disc arthroplasty: more heterotopic ossification at the 5-year follow-up

2016 ◽  
Vol 24 (5) ◽  
pp. 752-759 ◽  
Author(s):  
Peng-Yuan Chang ◽  
Hsuan-Kan Chang ◽  
Jau-Ching Wu ◽  
Wen-Cheng Huang ◽  
Li-Yu Fay ◽  
...  
Keyword(s):  
Cervical Spine ◽  
Heterotopic Ossification ◽  
Clinical Outcomes ◽  
Large Scale ◽  
Japanese Orthopaedic Association ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Disc Arthroplasty ◽  
Arm Pain

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.

Cervical disc arthroplasty for less-mobile discs

2019 ◽  
Vol 31 (3) ◽  
pp. 310-316 ◽  
Author(s):  
Tsung-Hsi Tu ◽  
Chu-Yi Lee ◽  
Chao-Hung Kuo ◽  
Jau-Ching Wu ◽  
Hsuan-Kan Chang ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Japanese Orthopaedic Association ◽  
Neck Disability Index ◽  
Cervical Radiculopathy ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Segmental Mobility ◽  
Disc Arthroplasty ◽  
Flexion Extension ◽  
Index Level

OBJECTIVEThe published clinical trials of cervical disc arthroplasty (CDA) have unanimously demonstrated the success of preservation of motion (average 7°–9°) at the index level for up to 10 years postoperatively. The inclusion criteria in these trials usually required patients to have evident mobility at the level to be treated (≥ 2° on lateral flexion-extension radiographs) prior to the surgery. Although the mean range of motion (ROM) remained similar after CDA, it was unclear in these trials if patients with less preoperative ROM would have different outcomes than patients with more ROM.METHODSA series of consecutive patients who underwent CDA at the level of C5–6 were followed up and retrospectively reviewed. The indications for surgery were medically refractory cervical radiculopathy, myelopathy, or both, caused by cervical disc herniation or spondylosis. All patients were assigned to 1 of 2 groups: a less-mobile group, which consisted of those patients who had an ROM of ≤ 5° at C5–6 preoperatively, or a more-mobile group, which consisted of patients whose ROM at C5–6 was > 5° preoperatively. Clinical outcomes, including visual analog scale, Neck Disability Index, and Japanese Orthopaedic Association Scale scores, were evaluated at each time point. Radiological outcomes were also assessed.RESULTSA total of 60 patients who had follow-up for more than 2 years were analyzed. There were 27 patients in the less-mobile group (mean preoperative ROM 3.0°) and 33 in the more-mobile group (mean ROM 11.7°). The 2 groups were similar in demographics, including age, sex, diabetes, and cigarette smoking. Both groups had significant improvements in clinical outcomes, with no significant differences between the 2 groups. However, the radiological evaluations demonstrated remarkable differences. The less-mobile group had a greater increase in ΔROM than the more-mobile group (ΔROM 5.5° vs 0.1°, p = 0.001), though the less-mobile group still had less segmental mobility (ROM 8.5° vs 11.7°, p = 0.04). The rates of complications were similar in both groups.CONCLUSIONSPreoperative segmental mobility did not alter the clinical outcomes of CDA. The preoperatively less-mobile (ROM ≤ 5°) discs had similar clinical improvements and greater increase of segmental mobility (ΔROM), but remained less mobile, than the preoperatively more-mobile (ROM > 5°) discs at 2 years postoperatively.

scholarly journals Occurrence and clinical implications of heterotopic ossification after cervical disc arthroplasty with the Prestige LP Cervical Disc at 2 contiguous levels

2020 ◽  
Vol 33 (1) ◽  
pp. 41-50
Author(s):  
Matthew F. Gornet ◽  
Todd H. Lanman ◽  
J. Kenneth Burkus ◽  
Randall F. Dryer ◽  
Jeffrey R. McConnell ◽  
...  
Keyword(s):  
Heterotopic Ossification ◽  
Clinical Outcomes ◽  
Statistical Difference ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Disc Arthroplasty ◽  
Arm Pain ◽  
The Impact ◽  
Grade Iii ◽  
The Prestige

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.

Radiological and clinical outcomes of 3-level cervical disc arthroplasty

2020 ◽  
Vol 32 (2) ◽  
pp. 174-181 ◽  
Author(s):  
Hsuan-Kan Chang ◽  
Wen-Cheng Huang ◽  
Tsung-Hsi Tu ◽  
Li-Yu Fay ◽  
Chao-Hung Kuo ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Large Scale ◽  
Japanese Orthopaedic Association ◽  
Neck Disability Index ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Disc Arthroplasty ◽  
Arm Pain ◽  
Estimated Blood Loss

OBJECTIVEOne- and two-level cervical disc arthroplasty (CDA) has been compared to anterior cervical discectomy and fusion (ACDF) in several large-scale, prospective, randomized trials that have demonstrated similar clinical outcomes. However, whether these results would be similar when treating 3-level disc herniation and/or spondylosis has remained unanswered. This study aimed to investigate the differences between 3-level CDA and ACDF.METHODSA series of 50 patients who underwent 3-level CDA at C3–7 was retrospectively reviewed and compared with another series of 50 patients (age- and sex-matched controls) who underwent ACDF at C3–7. Clinical outcomes were measured using the visual analog scale (VAS) for neck and arm pain, the modified Japanese Orthopaedic Association (mJOA) scale, and the Neck Disability Index (NDI). Radiological outcomes included range of motion (ROM) at the index levels. Every patient was evaluated by CT for the presence of fusion in the ACDF group. Also, complication profiles were investigated.RESULTSThe demographics and levels of distribution in both groups were very similar. During the follow-up period of 24 months, clinical outcomes improved (overall and respectively in each group) for both the CDA and ACDF patients when compared with the patients’ preoperative condition. There were essentially few differences between the two groups in terms of neck and arm pain VAS scores, mJOA scores, and NDI scores preoperatively and at 3, 6, 12, and 24 months postoperatively. After the 3-level surgery, the CDA group had an increased mean ROM of approximately 3.4°, at 25.2° ± 8.84°, compared to their preoperative ROM (21.8° ± 7.20°) (p = 0.001), whereas the ACDF group had little mobility (22.8° ± 5.90° before and 1.0° ± 1.28° after surgery; p < 0.001). The mean operative time, estimated blood loss, and complication profiles were similar for both groups.CONCLUSIONSIn this selectively matched retrospective study, clinical outcomes after 3-level CDA and ACDF were similar during the 2-year follow-up period. CDA not only successfully preserved but slightly increased the mobility at the 3 index levels. However, the safety and efficacy of 3-level CDA requires more long-term data for validatation.

scholarly journals Effects of smoking on cervical disc arthroplasty

2019 ◽  
Vol 30 (2) ◽  
pp. 168-174 ◽  
Author(s):  
Tsung-Hsi Tu ◽  
Chao-Hung Kuo ◽  
Wen-Cheng Huang ◽  
Li-Yu Fay ◽  
Henrich Cheng ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Smoking Status ◽  
Japanese Orthopaedic Association ◽  
Neck Disability Index ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Disc Arthroplasty ◽  
Arm Pain ◽  
Smoking Group

OBJECTIVECigarette smoking can adversely affect bone fusion in patients who undergo anterior cervical discectomy and fusion. However, there is a paucity of data on smoking among patients who have undergone cervical disc arthroplasty (CDA). The present study aimed to compare the clinical and radiological outcomes of smokers to those of nonsmokers following CDA.METHODSThe authors retrospectively reviewed the records of consecutive patients who had undergone 1- or 2-level CDA for cervical disc herniation or spondylosis and had a minimum 2-year follow-up. All patients were grouped into a smoking group, which consisted of those who had consumed cigarettes within 6 months prior to the CDA surgery, or a nonsmoking group, which consisted of those who had not consumed cigarettes at all or within 6 months of the CDA. Clinical outcomes were evaluated according to the visual analog scale for neck and arm pain, Neck Disability Index, Japanese Orthopaedic Association Scale, and Nurick Scale at each time point of evaluation. Radiological outcomes were assessed using radiographs and CT for multiple parameters, including segmental range of motion (ROM), neutral lordotic curve, and presence of heterotopic ossification (HO).RESULTSA total of 109 patients completed at least 2 years of follow-up and were analyzed (mean follow-up 42.3 months). There were 89 patients in the nonsmoking group and 20 in the smoking group. The latter group was younger and predominantly male (both p < 0.05) compared to the nonsmoking group. The two groups had similar improvements in all clinical outcomes after CDA compared to preoperatively. Radiological evaluations were also very similar between the two groups, except for two factors. The smoking group had well-preserved segmental ROM after CDA at an average of 8.1° (both pre- and postoperation). However, while the nonsmoking group remained mobile, segmental ROM decreased significantly (8.2° to 6.9°, p < 0.05) after CDA. There was a trend toward more HO development in the nonsmoking group than in the smoking group, but the difference was without significance (59.6% vs 50.0%, p = 0.43).CONCLUSIONSDuring an average 3.5 years of follow-up after 1- and 2-level CDA, cigarette smokers and nonsmokers had similar improvements in clinical outcomes. Moreover, segmental mobility was slightly better preserved in smokers. Since smoking status did not negatively impact outcomes, CDA may be a reasonable option for selected patients who have smoked.

Clinical Outcomes for Worker’s Compensation Patients After Cervical Disc Arthroplasty

2011 ◽  
Vol 11 (10) ◽  
pp. S105-S106
Author(s):  
Matthew Gornet ◽  
Brett Taylor ◽  
Todd Lanman ◽  
John Peloza ◽  
Randall Dryer ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Worker's Compensation ◽  
Disc Arthroplasty ◽  
Worker’S Compensation

Long-term Clinical Outcomes of Cervical Disc Arthroplasty

Spine ◽  
2017 ◽  
Vol 42 (4) ◽  
pp. 209-216 ◽  
Author(s):  
Willa R. Sasso ◽  
Joseph D. Smucker ◽  
Maria P. Sasso ◽  
Rick C. Sasso
Keyword(s):  
Clinical Outcomes ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Disc Arthroplasty

scholarly journals Adverse Events Following Cervical Disc Arthroplasty: A Systematic Review

2017 ◽  
Vol 8 (2) ◽  
pp. 178-189 ◽  
Author(s):  
Jordan C. Xu ◽  
Chandni Goel ◽  
Michael F. Shriver ◽  
Joseph E. Tanenbaum ◽  
Michael P. Steinmetz ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Industry Funding ◽  
Quality Of Reporting ◽  
Cervical Arthroplasty ◽  
Disc Arthroplasty ◽  
Vascular Compromise

Study Design: Systematic review. Objectives: Cervical arthroplasty is an increasingly popular treatment of cervical radiculopathy and myelopathy. An understanding of the potential adverse events (AEs) is important to help both clinicians and patients. We sought to provide a comprehensive systematic review of the AEs reported in all randomized controlled trials (RCTs) of cervical disc arthroplasty in an attempt to characterize the quality of reporting. Methods: We conducted a systematic review of MEDLINE and Web of Science for RCTs of cervical disc arthroplasty reporting AEs. We reported the most frequently mentioned AEs, including dysphagia/dysphonia, vascular compromise, dural injury, and infections. We recorded the presence of industry funding and scored the quality of collection methods and reporting of AEs. Results: Of the 3734 identified articles, 29 articles met full inclusion criteria. The quality of AE reporting varied significantly between studies, and a combined meta-analysis was not feasible. The 29 articles covered separate 19 RCTs. Eight studies were US Food and Drug Administration (FDA) investigational device exemption (IDE) trials. Rates were recorded for the following AEs: dysphagia/dysphonia (range = 1.3% to 27.2%), vascular compromise (range = 1.1% to 2.4%), cervical wound infection (range = 1.2% to 22.5%), and cerebrospinal fluid leak (range = 0.8% to 7.1%). Conclusions: There is a lack of consistency in reporting of AEs among RCTs of cervical arthroplasty. FDA IDE trials scored better in AE event reporting compared to other studies. Standardized definitions for AEs and standardized data collection methodology are needed to improve future studies.

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