Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing Mobi-C Cervical Artificial Disc to anterior discectomy and fusion in the treatment of symptomatic degenerative disc disease in the cervical spine

Michael S Hisey, Hyun W Bae, Reginald Davis, Steven Gaede, Greg Hoffman, Kee Kim, Pierce D Nunley, Daniel Peterson, Ralph Rashbaum, John Stokes, Michael S Hisey, Hyun W Bae, Reginald Davis, Steven Gaede, Greg Hoffman, Kee Kim, Pierce D Nunley, Daniel Peterson, Ralph Rashbaum, John Stokes

Abstract

Background: Anterior cervical discectomy and fusion (ACDF) is the gold standard for treating symptomatic cervical disc degeneration. Cervical total disc replacements (TDRs) have emerged as an alternative for some patients. The purpose of this study was to evaluate the safety and effectiveness of a new TDR device compared with ACDF for treating single-level cervical disc degeneration.

Methods: This was a prospective, randomized, controlled, multicenter Food and Drug Administration (FDA) regulated Investigational Device Exemption (IDE) study. A total of 245 patients were treated (164 TDR: 81 ACDF). The primary outcome measure was overall success based on improvement in Neck Disability Index (NDI), no subsequent surgical interventions, and no adverse events (AEs) classified as major complications. Secondary outcome measures included SF-12, visual analog scale (VAS) assessing neck and arm pain, patient satisfaction, radiographic range of motion, and adjacent level degeneration. Patients were evaluated preoperatively and postoperatively at 6 weeks, 3, 6, 12, 18, and 24 months. The hypothesis was that the TDR success rate was non-inferior to ACDF at 24 months.

Results: Overall success rates were 73.6% for TDR and 65.3% for ACDF, confirming non-inferiority (p < 0.0025). TDR demonstrated earlier improvements with significant differences in NDI scores at 6 weeks and 3 months, and VAS neck pain and SF-12 PCS scores at 6 weeks (p<0.05). Operative level range of motion in the TDR group was maintained throughout follow-up. Radiographic evidence of inferior adjacent segment degeneration was significantly greater with ACDF at 12 and 24 months (p < 0.05). AE rates were similar.

Conclusions: Mobi-C TDR is a safe and effective treatment for single-level disc degeneration, producing outcomes similar to ACDF with less adjacent segment degeneration.

Level of evidence: Level I.

Clinical relevance: This study adds to the literature supporting cervical TDR as a viable option to ACDF in appropriately selected patients with disc degeneration.

Keywords: Cervical Spine; anterior cervical fusion; clinical outcome; randomized study; total disc replacement.

Figures

Fig. 1
Fig. 1
Mobi-C Artificial Cervical Disc (LDR Medical; Troyes, France). Allows for five independent degrees of freedom.
Fig. 2
Fig. 2
TDR device in proper placement. Lateral flexion and extension x-rays of the TDR at 24 months.
Fig. 3
Fig. 3
Overall Study Success at 24 Months. Bar graph showing over all clinical success rate at 24 months. Also shown are the success rates at 24 months of the components of the composite endpoint: NDI success rate, Device success rate (no need for subsequent surgeries, and the percentage of patients who had no major complications.
Fig. 4
Fig. 4
Overall Study Success Rates by Time point. Success rates are shown for both TDR group and ACDF group both with and without failures due only to radiographic major complications. Non-inferiority is demonstrated at each time point for both TDR compared to ACDF in both cases.
Fig. 5
Fig. 5
Mean NDI Score by Time point. NDI scores were collected at each visit. Error bars represent standard deviations. NDI scores for both treatment groups were significantly different from baseline at all time points (p

Fig. 6

Mean VAS scores by Time…

Fig. 6

Mean VAS scores by Time point. VAS pain scores were collected at each…

Fig. 6
Mean VAS scores by Time point. VAS pain scores were collected at each follow-up visit. Error bars represent standard deviations. VAS scores for both treatment groups were significantly different from baseline at all time points (p

Fig. 7

Range of Motion by Time…

Fig. 7

Range of Motion by Time point. Line graph demonstrating range of motion at…

Fig. 7
Range of Motion by Time point. Line graph demonstrating range of motion at the treated segment in Flexion/Extension (F/E) and Right/Left Lateral Bending (LB)

Fig. 8

Mean SF-12 PCS and MCS…

Fig. 8

Mean SF-12 PCS and MCS scores by Time point. SF-12 physical component score…

Fig. 8
Mean SF-12 PCS and MCS scores by Time point. SF-12 physical component score (PCS) and mental health component score (MCS) were collected at baseline, 6, 12, 18, and 24 months. Error bars represent standard deviations. SF-12 scores for both treatment groups were significantly different from baseline at all time points (p
All figures (8)
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References
    1. Denaro V, Papalia R, Denaro L, et al. Cervical spinal disc replacement. J Bone Joint Surg Br. 2009;91:713–9. - PubMed
    1. Denaro V, Di Martino A. Cervical spine surgery: an historical perspective. Clin Orthop Relat Res. 2011;469:639–48. - PMC - PubMed
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Fig. 6
Fig. 6
Mean VAS scores by Time point. VAS pain scores were collected at each follow-up visit. Error bars represent standard deviations. VAS scores for both treatment groups were significantly different from baseline at all time points (p

Fig. 7

Range of Motion by Time…

Fig. 7

Range of Motion by Time point. Line graph demonstrating range of motion at…

Fig. 7
Range of Motion by Time point. Line graph demonstrating range of motion at the treated segment in Flexion/Extension (F/E) and Right/Left Lateral Bending (LB)

Fig. 8

Mean SF-12 PCS and MCS…

Fig. 8

Mean SF-12 PCS and MCS scores by Time point. SF-12 physical component score…

Fig. 8
Mean SF-12 PCS and MCS scores by Time point. SF-12 physical component score (PCS) and mental health component score (MCS) were collected at baseline, 6, 12, 18, and 24 months. Error bars represent standard deviations. SF-12 scores for both treatment groups were significantly different from baseline at all time points (p
All figures (8)
Similar articles
Cited by
References
    1. Denaro V, Papalia R, Denaro L, et al. Cervical spinal disc replacement. J Bone Joint Surg Br. 2009;91:713–9. - PubMed
    1. Denaro V, Di Martino A. Cervical spine surgery: an historical perspective. Clin Orthop Relat Res. 2011;469:639–48. - PMC - PubMed
    1. Mummaneni PV, Haid RW. The future in the care of the cervical spine: interbody fusion and arthroplasty. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004. J Neurosurg Spine. 2004;1:155–9. - PubMed
    1. Brodke DS, Zdeblick T. Modified Smith-Robinson procedure for anterior cervical discectomy and fusion. Spine. 1992;17(suppl):427–30. - PubMed
    1. Bohlman HH, Emery SE, Goodfellow DB, Jones PK. Robinson anterior cervical discectomy and arthrodesis for cervical radiculopathy. Long-term follow-up of one hundred and twenty-two patients. J Bone Joint Surg Am. 1993;75:1298–307. - PubMed
Show all 37 references
Related information
Full text links [x]
[x]
Cite
Copy Download .nbib
Format: AMA APA MLA NLM
Fig. 7
Fig. 7
Range of Motion by Time point. Line graph demonstrating range of motion at the treated segment in Flexion/Extension (F/E) and Right/Left Lateral Bending (LB)
Fig. 8
Fig. 8
Mean SF-12 PCS and MCS scores by Time point. SF-12 physical component score (PCS) and mental health component score (MCS) were collected at baseline, 6, 12, 18, and 24 months. Error bars represent standard deviations. SF-12 scores for both treatment groups were significantly different from baseline at all time points (p
All figures (8)

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