Long-Term Efficacy and Safety of Anterior Cervical Discectomy and Fusion in Single-Level Cervical Disk Disease: 7 Years Follow-up of Food and Drug Administration Investigational Exemption ProDisc-C Study

Study Design: Retrospective radiographic investigation. Objective: To evaluate the long-term radiographic and functional outcomes of patients in whom there is absence of radiographic union at 2 years after single-level anterior cervical discectomy and fusion (ACDF). Methods: Thirty-one patients were evaluated at standard postoperative time intervals per index trial protocol. Plain film radiographic fusion criteria at the arthrodesis level was defined as interspinous motion (ISM) <1 mm with corresponding motion at a non-arthrodesed superjacent level ISM ≥4 mm. Radiographs and functional outcome measures were acquired at each follow-up visit. Delayed union was defined as lack of radiographic union by 24 months. Results: Nine patients demonstrated radiographic evidence of delayed radiographic union at 24 months. Of those 9 patients, 5 patients demonstrated evidence of union during the follow-up period to 72 months. Despite the absence of radiographic union based on our criteria, 3 of the 4 remaining patients reported remarkable improvements in pain scores and functional outcomes. Conclusions: The natural history of delayed union at 24 months after ACDF was still favorable despite the prolonged delay in union. The majority of patients (5 of 9) without radiographic union at 24 months did proceed to radiographic union by final follow-up. In addition, patients that did not meet our criteria for fusion maintained postoperative improvements in patient-reported outcome scores. In summary, our study patients undergoing a single-level ACDF with asymptomatic radiographic delayed union at 24 months can expect maintained improvements in postoperative patient-reported outcomes scores and can still progress to successful radiographic fusion.

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Prospective randomized study of cervical arthroplasty and anterior cervical discectomy and fusion with long-term follow-up: results in 74 patients from a single site

Journal of Neurosurgery Spine ◽

10.3171/2012.9.spine12555 ◽

2013 ◽

Vol 18 (1) ◽

pp. 36-42 ◽

Cited By ~ 91

Author(s):

Domagoj Coric ◽

Paul K. Kim ◽

Jonathan D. Clemente ◽

Margaret O. Boltes ◽

Marcy Nussbaum ◽

...

Keyword(s):

Cervical Radiculopathy ◽

Reoperation Rate ◽

Anterior Cervical Discectomy ◽

Adjacent Level ◽

Cervical Discectomy ◽

Single Level ◽

Bryan Disc ◽

Long Term Follow Up

Object The purpose of this study was to evaluate the long-term results of cervical total disc replacement (TDR) and anterior cervical discectomy and fusion (ACDF) in the treatment of single-level cervical radiculopathy. Methods The results of 2 separate prospective, randomized, US FDA Investigational Device Exemption pivotal trials (Bryan Disc and Kineflex|C) from a single investigational site were combined to evaluate outcomes at long-term follow-up. The primary clinical outcome measures included the Neck Disability Index (NDI), visual analog scale (VAS), and neurological examination. Patients were randomized to receive cervical TDR in 2 separate prospective, randomized studies using the Bryan Disc or Kineflex|C cervical artificial disc compared with ACDF using structural allograft and an anterior plate. Patients were evaluated preoperatively; at 6 weeks; at 3, 6, and 12 months; and then yearly for a minimum of 48 months. Plain radiographs were obtained at each study visit. Results A total of 74 patients were enrolled and randomly assigned to either the cervical TDR (n = 41) or ACDF (n = 33) group. A total of 63 patients (86%) completed a minimum of 4 years follow-up. Average follow-up was 6 years (72 months) with a range from 48 to 108 months. In both the cervical TDR and ACDF groups, mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the minimum 48-month follow-up (p < 0.001). Similarly, the median VAS pain scores improved significantly by 6 weeks and remained significantly improved throughout the minimum 48-month follow-up (p < 0.001). There were no significant differences between groups in mean NDI or median VAS scores. The range of motion (ROM) in the cervical TDR group remained significantly greater than the preoperative mean, whereas the ROM in the ACDF group was significantly reduced from the preoperative mean. There was significantly greater ROM in the cervical TDR group compared with the ACDF group. There were 3 reoperations (7.3%) at index or adjacent levels in the cervical TDR group; all were cervical laminoforaminotomies. There were 2 adjacent-level reoperations in the cervical TDR group (4.9%). There was 1 reoperation (3.0%) in the ACDF group at an index or adjacent level (a second ACDF at the adjacent level). There was no statistically significant difference in overall reoperation rate or adjacent-level reoperation rate between groups. Conclusions Both cervical TDR and ACDF groups showed excellent clinical outcomes that were maintained over long-term follow-up. Both groups showed low index-level and adjacent-level reoperation rates. Both cervical TDR and ACDF appear to be viable options for the treatment of single-level cervical radiculopathy.

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i-Factor™ Bone Graft versus Autograft in Anterior Cervical Discectomy and Fusion: Two-Year Follow-Up of the Randomized Single-Blinded Food and Drug Administration Investigational Device Exemption Study

The Spine Journal ◽

10.1016/j.spinee.2016.07.051 ◽

2016 ◽

Vol 16 (10) ◽

pp. S153-S154

Author(s):

Paul M. Arnold ◽

Rick C. Sasso ◽

Michael E. Janssen ◽

Michael G. Fehlings ◽

Robert F. Heary ◽

...

Keyword(s):

Bone Graft ◽

Drug Administration ◽

Food And Drug Administration ◽

Anterior Cervical Discectomy ◽

Cervical Discectomy ◽

Investigational Device Exemption ◽

I Factor

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Long‐term efficacy and safety of risankizumab for the treatment of moderate‐to‐severe plaque psoriasis: interim analysis of the LIMMitless open‐label extension trial beyond 3 years of follow‐up

British Journal of Dermatology ◽

10.1111/bjd.20595 ◽

2021 ◽

Author(s):

K.A. Papp ◽

M.G. Lebwohl ◽

L. Puig ◽

M. Ohtsuki ◽

S. Beissert ◽

...

Keyword(s):

Plaque Psoriasis ◽

Interim Analysis ◽

Efficacy And Safety ◽

Open Label ◽

Severe Plaque Psoriasis ◽

Term Efficacy ◽

Open Label Extension ◽

Extension Trial

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Post-Operative Dysphagia in Anterior Cervical Discectomy and Fusion

Annals of Otology Rhinology & Laryngology ◽

10.1177/00034894211015582 ◽

2021 ◽

pp. 000348942110155

Author(s):

Leonard Haller ◽

Khush Mehul Kharidia ◽

Caitlin Bertelsen ◽

Jeffrey Wang ◽

Karla O’Dell

Keyword(s):

Risk Factors ◽

Medical Records ◽

Assessment Tool ◽

Demographic Data ◽

Anterior Cervical Discectomy ◽

Cervical Discectomy ◽

Long Term Follow Up

Objective: We sought to identify risk factors associated with long-term dysphagia, characterize changes in dysphagia over time, and evaluate the incidence of otolaryngology referrals for patients with long-term dysphagia following anterior cervical discectomy with fusion (ACDF). Methods: About 56 patients who underwent ACDF between May 2017 to February 2019 were included in the study. All patients were assessed for dysphagia using the Eating Assessment Tool (EAT-10) survey preoperatively and late postoperatively (≥1 year). Additionally, 28 patients were assessed for dysphagia early postoperatively (2 weeks—3 months). Demographic data, medical comorbidities, intraoperative details, and post-operative otolaryngology referral rates were collected from electronic medical records. Results: Of the 56 patients enrolled, 21 patients (38%) had EAT-10 scores of 3 or more at long-term follow-up. None of the demographics, comorbidities, or surgical factors assessed were associated with long-term dysphagia. Patients who reported no long-term dysphagia had a mean EAT-10 score of 6.9 early postoperatively, while patients with long-term symptoms had a mean score of 18.1 ( P = .006). Of the 21 patients who reported persistent dysphagia symptoms, 3 (14%) received dysphagia testing or otolaryngology referrals post-operatively. Conclusion: Dysphagia is a notable side effect of ACDF surgery, but there are no significant demographics, comorbidities, or surgical risk factors that predict long-term dysphagia. Early postoperative characterization of dysphagia using the EAT-10 questionnaire can help predict long-term symptoms. There is inadequate screening and otolaryngology follow-up for patients with post-ACDF dysphagia.

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