Analysis of the three United States Food and Drug Administration investigational device exemption cervical arthroplasty trials

2012 ◽  
Vol 16 (3) ◽  
pp. 216-228 ◽  
Author(s):  
Cheerag D. Upadhyaya ◽  
Jau-Ching Wu ◽  
Gregory Trost ◽  
Regis W. Haid ◽  
Vincent C. Traynelis ◽  
...  
Keyword(s):  
Random Effects ◽  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Adjacent Level ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Single Level ◽  
Investigational Device Exemption ◽  
Time Point

Object There are now 3 randomized, multicenter, US FDA investigational device exemption, industry-sponsored studies comparing arthroplasty with anterior cervical discectomy and fusion (ACDF) for single-level cervical disease with 2 years of follow-up. These 3 studies evaluated the Prestige ST, Bryan, and ProDisc-C artificial discs. The authors analyzed the combined results of these trials. Methods A total of 1213 patients with symptomatic, single-level cervical disc disease were randomized into 2 treatment arms in the 3 randomized trials. Six hundred twenty-one patients received an artificial cervical disc, and 592 patients were treated with ACDF. In the three trials, 94% of the arthroplasty group and 87% of the ACDF group have completed 2 years of follow-up. The authors analyzed the 2-year data from these 3 trials including previously unpublished source data. Statistical analysis was performed with fixed and random effects models. Results The authors' analysis revealed that segmental sagittal motion was preserved with arthroplasty (preoperatively 7.26° and postoperatively 8.14°) at the 2-year time point. The fusion rate for ACDF at 2 years was 95%. The Neck Disability Index, 36-Item Short Form Health Survey Mental, and Physical Component Summaries, neck pain, and arm pain scores were not statistically different between the groups at the 24-month follow-up. The arthroplasty group demonstrated superior results at 24 months in neurological success (RR 0.595, I2 = 0%, p = 0.006). The arthroplasty group had a lower rate of secondary surgeries at the 2-year time point (RR 0.44, I2 = 0%, p = 0.004). At the 2-year time point, the reoperation rate for adjacent-level disease was lower for the arthroplasty group when the authors analyzed the combined data set using a fixed effects model (RR 0.460, I2 = 2.9%, p = 0.030), but this finding was not significant using a random effects model. Adverse event reporting was too heterogeneous between the 3 trials to combine for analysis. Conclusions Both anterior cervical discectomy and fusion as well as arthroplasty demonstrate excellent 2-year surgical results for the treatment of 1-level cervical disc disease with radiculopathy. Arthroplasty is associated with a lower rate of secondary surgery and a higher rate of neurological success at 2 years. Arthroplasty may be associated with a lower rate of adjacent-level disease at 2 years, but further follow-up and analysis are needed to confirm this finding.

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.

ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease

2015 ◽  
Vol 97 (21) ◽  
pp. 1738-1747 ◽  
Author(s):  
Michael E. Janssen ◽  
Jack E. Zigler ◽  
Jeffrey M. Spivak ◽  
Rick B. Delamarter ◽  
Bruce V. Darden ◽  
...  
Keyword(s):  
Total Disc Replacement ◽  
Anterior Cervical Discectomy ◽  
Disc Replacement ◽  
Cervical Disc ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Cervical Discectomy ◽  
Single Level

scholarly journals Outcome of Anterior Cervical Discectomy with PEEK Cage Fixation for Single Level Cervical Disc Disease

2020 ◽  
Vol 24 (2) ◽  
pp. 138-142
Author(s):  
SAJID KHAN ◽  
AKRAM ULLAH ◽  
MUSAWER KHAN ◽  
RAMZAN HUSSAIN ◽  
MUMTAZ ALI
Keyword(s):  
Radicular Pain ◽  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Peek Cage ◽  
Cervical Disc Disease ◽  
Mri Findings ◽  
Disc Disease ◽  
Cervical Discectomy ◽  
Prolapsed Disc

Objective:  To assess the outcome of anterior cervical discectomy and fusion (ACDF) with PEEK cage. Material and Methods:  This prospective study was conducted in the Departments of Neurosurgery Prime Teaching Hospital and Irfan General Hospital Peshawar. Patients undergoing one level ACDF with PEEK cage fixation were enrolled in the study. Patients who needed multiple level ACDF or corpectomy with plating and redo cases were excluded from the study. A proforma, which included age, gender, address, level of prolapsed disc, sign and symptoms, pain score, MRI findings were filled. All patients were assessed on day of discharge and on follow-up visit after one month. Data was analyzed with SPSS version 22. Results:  Total 95 patients were included out of which 58 (61%) were male and 37 (39%) were female. Range of patients` Age was from 27 years to 64 years with 50.4 years mean age. Most patients (65%) had C6 radiculopathy. 58 patients (61%) had right sided radicular pain. 5 patients (5.26%) had radiculomyelopathy. C5 – C6 was the most common level operated (68 patients). Excellent results were achieved in 75 patients (79%) while satisfactory results in the rest of patients using Odom’s criteria. Bony fusion occurred in 92% of patients at 6 months. Conclusion:  ACDF with PEEK cage fixation is a safe and beneficial procedure in one level cervical prolapse disc disease

scholarly journals Clinical Course of Cervical Percutaneous Epidural Neuroplasty in Single-Level Cervical Disc Disease with 12-Month Follow-up

2017 ◽  
Vol 6 (20;6) ◽  
pp. E941-E949
Author(s):  
Dong Ah Shin
Keyword(s):  
Neck Pain ◽  
Clinical Course ◽  
Cervical Disc ◽  
Control Group ◽  
Consecutive Series ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Single Level ◽  
Arm Pain

Background: Cervical disc disease is a common and occasionally disabling condition, occurring as a natural consequence of aging in the vast majority of the adult population. Percutaneous epidural neuroplasty (PEN) has been used to deliver highly concentrated drugs for chronic neck pain and to prevent scarring in cases refractory to conventional epidural blocks. However, the clinical course after PEN in cervical disc disease is not well-documented. Objective: The purpose of this study was to evaluate the efficacy of cervical PEN for single-level cervical disc disease. Study Design: A retrospective observational study. Methods: A consecutive series of 100 patients who underwent cervical PEN for single-level disc disease (bulging or protrusion) were included in this study. Preoperatively, all patients underwent magnetic resonance imaging (MRI), and visual analog scale (VAS) scores as well as Odom’s criteria were measured preoperatively and at post-operative follow-up visits (one, 3, 6, and 12 months). Limitations: The results of this study are limited by the lack of a control group that did not undergo treatment with PEN. Results: Additional block therapy was performed in 58 patients (58.0%). Subsequent surgery was performed in 10 patients (10.0%, excluded from data of clinical follow-up). Mean neck pain and VAS arm pain scores for all follow-up patients decreased from 6.82 and 4.74 preoperatively to 2.18 and 1.87 at 12 months after PEN (P < 0.001). More than 80% and 40% of all patients with and without additional block therapy after cervical PEN, respectively, showed good and excellent outcomes according to Odom’s Criteria during 12 months of follow-up. During this follow-up period, no severe complications related to the procedure were observed. Conclusion: Cervical PEN was shown to be a safe and effective treatment for neck and arm pain in single-level disc disease during 12 months of follow-up.

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