Comparison between single- and multi-level patients: clinical and radiological outcomes 2 years after cervical disc replacement

Huppert, Jean; Beaurain, Jacques; Steib, Jean-Paul; Bernard, Pierre; Dufour, Thierry; Hovorka, I.; Stecken, J; Dam-Hieu, Phong; Fuentes, J. M.; Vital, Jean-Marc; Vila, Thierry; Aubourg, Lucie

doi:10.1007/s00586-011-1722-9

Cited by 83 publications

(76 citation statements)

References 20 publications

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C erviCal total disc replacement (cTDR) in properly indicated patients with single-level cervical disc pathology has been demonstrated to achieve satisfactory neural decompression and clinical outcomes equivalent to or better 4,6,7,[14][15][16][17][18][19][20][21][22][23][24][25][26][27][28]38 than anterior cervical discectomy and fusion (ACDF) in 7 different prospective, randomized, controlled US FDA trials. Single-level longterm data have been published on the Bryan disc, 34 ProDisc-C, 41 and Prestige ST disc, 8 but this is the first report on the 5-year investigational device exemption (IDE) data for 2-level cervical arthroplasty.

Although both ACDF and cTDR satisfactorily treat clinically symptomatic cervical pathology, arthrodesis alters cervical mechanics 1,2,11 by placing increased stresses on ad- obJective The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF).

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confidence: 99%

Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial

Radcliff

Coric

Albert

2016

SPI

121

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OBJECTIVE The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF). Although the long-term outcome of single-level disc replacement has been extensively described, there have not been previous reports of the 5-year outcome of 2-level cervical disc replacement. METHODS This study reports the 5-year results of a prospective, randomized US FDA investigational device exemption (IDE) study conducted at 24 centers in patients with 2-level, contiguous, cervical spondylosis. Clinical outcomes at up to 60 months were evaluated, including validated outcome measures, incidence of reoperation, and adverse events. The complete study data and methodology were critically reviewed by 3 independent surgeon authors without affiliation with the IDE study or financial or institutional bias toward the study sponsor. RESULTS A total of 225 patients received the Mobi-C cervical total disc replacement device and 105 patients received ACDF. The Mobi-C and ACDF follow-up rates were 90.7% and 86.7%, respectively (p = 0.39), at 60 months. There was significant improvement in all outcome scores relative to baseline at all time points. The Mobi-C patients had significantly more improvement than ACDF patients in terms of Neck Disability Index score, SF-12 Physical Component Summary, and overall satisfaction with treatment at 60 months. The reoperation rate was significantly lower with Mobi-C (4%) versus ACDF (16%). There were no significant differences in the adverse event rate between groups. CONCLUSIONS Both cervical total disc replacement and ACDF significantly improved general and disease-specific measures compared with baseline. However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients. Clinical trial registration no. NCT00389597 (clinicaltrials.gov)

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confidence: 99%

Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial

Radcliff

Coric

Albert

2016

SPI

121

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“…Therefore, the effects of the preservation of spinal segment motion by 1-or 2-level cervical arthroplasty in the treatment of CSM require further investigation. 5,9,18,26,27,33,41 The present study was thus designed to evaluate the outcome of arthroplasty in patients with radiculopathy compared with outcome in patients with CSM (with or without radiculopathy). Thus patients were divided into two groups: those who had myelopathy and those who had only radiculopathy.…”

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confidence: 99%

Arthroplasty for cervical spondylotic myelopathy: similar results to patients with only radiculopathy at 3 years' follow-up

Fay

Huang

et al. 2014

SPI

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Object Cervical arthroplasty has been accepted as a viable option for surgical management of cervical spondylosis or degenerative disc disease (DDD). The best candidates for cervical arthroplasty are young patients who have radiculopathy caused by herniated disc with competent facet joints. However, it remains uncertain whether arthroplasty is equally effective for patients who have cervical myelopathy caused by DDD. The aim of this study was to compare the outcomes of arthroplasty for patients with cervical spondylotic myelopathy (CSM) and patients with radiculopathy without CSM. Methods A total of 151 consecutive cases involving patients with CSM or radiculopathy caused by DDD and who underwent one- or two-level cervical arthroplasty were included in this study. Clinical outcome evaluations and radiographic studies were reviewed. Clinical outcome measurements included the Visual Analog Scale (VAS) of neck and arm pain, Japanese Orthopaedic Association (JOA) scores, and the Neck Disability Index (NDI) in every patient. For patients with CSM, Nurick scores were recorded for evaluation of cervical myelopathy. Radiographic studies included lateral dynamic radiographs and CT for detection of the formation of heterotopic ossification . Results Of the 151 consecutive patients with cervical DDD, 125 (82.8%; 72 patients in the myelopathy group and 53 in the radiculopathy group) had at least 24 months of clinical and radiographic follow-up. The mean duration of follow-up in these patients was 36.4 months (range 24–56 months). There was no difference in sex distribution between the 2 groups. However, the mean age of the patients in the myelopathy group was approximately 6 years greater than that of the radiculopathy group (53.1 vs 47.2 years, p < 0.001). The mean operation time, mean estimated blood loss, and the percentage of patients prescribed perioperative analgesic agents were similar in both groups (p = 0.754, 0.652, and 0.113, respectively). There were significant improvements in VAS neck and arm pain, JOA scores, and NDI in both groups. Nurick scores in the myelopathy group also improved significantly after surgery. In radiographic evaluations, 92.5% of patients in the radiculopathy group and 95.8% of those in the radiculopathy group retained spinal motion (no significant difference). Evaluation of CT scans showed heterotopic ossification in 34 patients (47.2%) in the myelopathy group and 25 patients (47.1%) in the radiculopathy group (p = 0.995). At a mean of over 3 years postoperatively, no secondary surgery was reported in either group. Conclusions The severity of myelopathy improves after cervical arthroplasty in patients with CSM caused by DDD. At 3-year follow-up, the clinical and radiographic outcomes of cervical arthroplasty in DDD patients with CSM are similar to those patients who have only cervical radiculopathy. Therefore, cervical arthroplasty is a viable option for patients with CSM caused by DDD who require anterior surgery. However, comparison with the standard surgical treatment of anterior cervical discectomy and fusion is necessary to corroborate the outcomes of arthroplasty for CSM.

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“…Pimenta et al 28 29 compared 56 patients undergoing ≥two-level CDR (Mobi-C) to 175 patients undergoing single-level CDR in a prospective, multicenter study. At 2-year follow-up, both groups had statistically significant improvements in NDI, arm VAS, neck VAS, and SF-36 scores.…”

Section: Clinical and Radiographic Postoperative Outcomesmentioning

confidence: 99%

“…In terms of total adverse events (AEs), multiple studies have identified a low rate of AEs coupled with no difference in AE rate between two-level CDR and either two-level cervical fusion or single-level CDR. 17,[26][27][28][29][30] Multiple retrospective case series have reported no significant AEs after 12-24 months postoperatively in patients undergoing two-level CDR. 26,30 Huppert et al 29 determined that while the incidence of total adverse events did not differ between groups undergoing two-level or single-level CDR, the incidence of dysphagia was significantly higher in patients undergoing multilevel surgery.…”

Section: Clinical and Radiographic Postoperative Outcomesmentioning

confidence: 99%

“…The reported rate of reoperation in two-level CDR patients among all included studies ranged from 0.0%-4.0%. 17,26,27,29 All studies supported at least noninferiority of two-level CDR, with Davis et al 27 being the only study to support a decreased rate of reoperation compared to two-level ACDF (4.0% versus 8.6%).…”

Section: Clinical and Radiographic Postoperative Outcomesmentioning

confidence: 99%

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Two-level cervical disc replacement: perspectives and patient selection

Narain¹,

Hijji²,

Bohl³

et al. 2017

OAS

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Introduction: Cervical disc replacement (CDR) is an emerging treatment option for cervical degenerative disease. Postulated benefits of cervical disc replacement compared to anterior cervical discectomy and fusion include preserved motion at the operative segments and decreased motion at adjacent levels. Multiple studies have been performed investigating the outcomes of CDR in single-level pathology. The investigation of the use of CDR in two-level pathology is an emerging topic within the literature. Purpose: To critically evaluate the literature regarding two-level CDR in order to determine its utility compared to two-level cervical arthrodesis. Patient selection factors including indications and contraindications will also be explored. Methods: The PubMed database was searched for all articles published on the subject of twolevel CDR up until October 2016. Studies were classified by publication year, study design, sample size, follow-up interval, and conflict of interest. Outcomes were recorded from each study, and included data on patient-reported outcomes, radiographic measurements, range of motion, peri-and postoperative complications, heterotopic ossification, adjacent segment disease, reoperation rate, and total intervention cost. Results: Fourteen studies were included in this review. All studies demonstrated at least noninferiority of two-level CDR compared to both two-level arthrodesis and single-level CDR. Patient selection in two-level CDR is driven by the inclusion and exclusion criteria presented in prospective, randomized controlled trials. The most common indication is subaxial degenerative disc disease over two contiguous levels presenting with radiculopathy or myelopathy. Furthermore, costs analyses trended toward at least noninferiority of two-level CDR. Conclusion: Two-level CDR is noninferior to two-level anterior cervical discectomy and fusion in terms of both outcomes and costs. While a few studies suggested superiority of two-level CDR, the presence of significant conflicts of interest by the study authors may introduce bias. Further prospective, randomized trials without conflicts of interest are necessary to determine if two-level CDR demonstrates truly superior outcomes.

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Comparison between single- and multi-level patients: clinical and radiological outcomes 2 years after cervical disc replacement

Cited by 83 publications

References 20 publications

Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial

Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial

Arthroplasty for cervical spondylotic myelopathy: similar results to patients with only radiculopathy at 3 years' follow-up

Two-level cervical disc replacement: perspectives and patient selection

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