Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial

Davis, Reginald J.; Kim, Kee D.; Hisey, Michael S.; Hoffman, Gregory A.; Bae, Hyun; Gaede, Steven E.; Rashbaum, Ralph F.; Nunley, Pierce D.; Peterson, Daniel L.; Stokes, John K.

doi:10.3171/2013.6.spine12527

Cited by 158 publications

(136 citation statements)

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“…12 In brief, this was a prospective, randomized multicenter study at 24 clinical sites between April 2006 and March 2008 comparing the outcome of cTDR (Mobi-C) versus ACDF. The control group underwent ACDF with a corticocancellous allograft and an anterior cervical plate.…”

Section: Methodsmentioning

confidence: 99%

“…1). 12 A 2:1 randomization design has been suggested as a way to improve the cost-effectiveness of clinical trials when there is a notable difference in cost between treatments. An unbalanced randomization is also appropriate as a way to increase patient access to a new therapy, especially when the outcomes of the control therapy are well understood.…”

Section: Treatment Assignmentmentioning

confidence: 99%

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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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Section: Methodsmentioning

confidence: 99%

Section: Treatment Assignmentmentioning

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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“…Numerous studies have demonstrated, however, that both cTDR and ACDF achieved comparatively similar improvements in all clinical outcome parameters [3,4,6,8,9,13,14]. However, a number of studies demonstrated that at short-and mid-term FU, the rates of post-operative revision surgeries were significantly lower and in favour of cTDR [1,3,5,15]. The underlying reasons for this observation included implant and technique-related issues, which were linked to the fusion of the segments (i.e.…”

Section: Discussionmentioning

confidence: 99%

“…Clinical studies have demonstrated this procedure to be a viable treatment alternative to the gold standard anterior cervical discectomy and fusion (ACDF) [1][2][3][4][5][6][7][8][9].…”

Section: Introductionmentioning

confidence: 99%

Clinical and radiological outcome at 10 years of follow-up after total cervical disc replacement

et al. 2017

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“…However, there are scarce data focusing on the extent of the post-CDA changes in segmental mobility or their clinical correlations. While the aforementioned Food and Drug Administration (FDA) trials successfully demonstrated preserved segmental mobility (as reflected by mean ROM) after CDA in hundreds of patients, 3,4,10,11,17,24,25,28,34 these trials did not address individual differences in change of mobility after CDA-in other words, a patient whose segmental mobility might increase (e.g., preoperative flexion and extension ROM of 6° at C5-6 increasing to 12° after surgery) or decrease after CDA (e.g., preoperative ROM of 12° decreasing to 6° after surgery). These two patients would be summed up as representing preservation of segmental mobility at an average ROM of 9°.…”

mentioning

confidence: 99%

Can segmental mobility be increased by cervical arthroplasty?

Chang

et al. 2017

FOC

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OBJECTIVE Many reports have successfully demonstrated that cervical disc arthroplasty (CDA) can preserve range of motion after 1- or 2-level discectomy. However, few studies have addressed the extent of changes in segmental mobility after CDA or their clinical correlations. METHODS Data from consecutive patients who underwent 1-level CDA were retrospectively reviewed. Indications for surgery were medically intractable degenerative disc disease and spondylosis. Clinical outcomes, including visual analog scale (VAS)–measured neck and arm pain, Neck Disability Index (NDI), and Japanese Orthopaedic Association (JOA) scores, were analyzed. Radiographic outcomes, including C2–7 Cobb angle, the difference between pre- and postoperative C2–7 Cobb angle (ΔC2–7 Cobb angle), sagittal vertical axis (SVA), the difference between pre- and postoperative SVA (ΔSVA), segmental range of motion (ROM), and the difference between pre- and postoperative ROM (ΔROM), were assessed for their association with clinical outcomes. All patients underwent CT scanning, by which the presence and severity of heterotopic ossification (HO) were determined during the follow-up. RESULTS A total of 50 patients (mean age 45.6 ± 9.33 years) underwent a 1-level CDA (Prestige LP disc) and were followed up for a mean duration of 27.7 ± 8.76 months. All clinical outcomes, including VAS, NDI, and JOA scores, improved significantly after surgery. Preoperative and postoperative ROM values were similar (mean 9.5° vs 9.0°, p > 0.05) at each indexed level. The mean changes in segmental mobility (ΔROM) were −0.5° ± 6.13°. Patients with increased segmental mobility after surgery (ΔROM > 0°) had a lower incidence of HO and HO that was less severe (p = 0.048) than those whose ΔROM was < 0°. Segmental mobility (ROM) was significantly lower in patients with higher HO grade (p = 0.012), but it did not affect the clinical outcomes. The preoperative and postoperative C2–7 Cobb angles and SVA remained similar. The postoperative C2–7 Cobb angles, SVA, ΔC2–7 Cobb angles, and ΔSVA were not correlated to clinical outcomes after CDA. CONCLUSIONS Segmental mobility (as reflected by the mean ROM) and overall cervical alignment (i.e., mean SVA and C2–7 Cobb angle) had no significant impact on clinical outcomes after 1-level CDA. Patients with increased segmental mobility (ΔROM > 0°) had significantly less HO and similarly improved clinical outcomes than those with decreased segmental mobility (ΔROM < 0°).

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Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial

Cited by 158 publications

References 46 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

Clinical and radiological outcome at 10 years of follow-up after total cervical disc replacement

Can segmental mobility be increased by cervical arthroplasty?

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