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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.

Hisey MS, Bae HW, Davis R, Gaede S, Hoffman G, Kim K, Nunley PD, Peterson D, Rashbaum R, Stokes J - Int J Spine Surg (2014)

Bottom Line: 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.Overall success rates were 73.6% for TDR and 65.3% for ACDF, confirming non-inferiority (p < 0.0025).Level I.

View Article: PubMed Central - PubMed

Affiliation: Texas Back Institute, Denton, TX.

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.

No MeSH data available.


Related in: MedlinePlus

TDR device in proper placement. Lateral flexion and extension x-rays of the TDR at 24 months.
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Figure 0002: TDR device in proper placement. Lateral flexion and extension x-rays of the TDR at 24 months.

Mentions: In the TDR group, following the discectomy, the disc space was distracted in parallel using a vertebral distractor. With normal disc height restored, distraction was maintained with a Caspar distractor. The cartilaginous endplates were removed to expose the underlying bone but no endplate shaping was performed. Using fluoroscopy and the trial instruments provided, the appropriate Mobi-C footprint and height were selected. The assembled prosthesis was then impacted into the prepared disc space using a self-retaining inserter. An adjustable stop allowed precise modification of the implant's anteroposterior (AP) position. Once final position was obtained, the distraction was released and slight compression was applied via the Caspar distractor to facilitate seating of the implant teeth into the vertebrae. AP and lateral fluoroscopy was used to confirm final implant position (Figure 2).


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.

Hisey MS, Bae HW, Davis R, Gaede S, Hoffman G, Kim K, Nunley PD, Peterson D, Rashbaum R, Stokes J - Int J Spine Surg (2014)

TDR device in proper placement. Lateral flexion and extension x-rays of the TDR at 24 months.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4325486&req=5

Figure 0002: TDR device in proper placement. Lateral flexion and extension x-rays of the TDR at 24 months.
Mentions: In the TDR group, following the discectomy, the disc space was distracted in parallel using a vertebral distractor. With normal disc height restored, distraction was maintained with a Caspar distractor. The cartilaginous endplates were removed to expose the underlying bone but no endplate shaping was performed. Using fluoroscopy and the trial instruments provided, the appropriate Mobi-C footprint and height were selected. The assembled prosthesis was then impacted into the prepared disc space using a self-retaining inserter. An adjustable stop allowed precise modification of the implant's anteroposterior (AP) position. Once final position was obtained, the distraction was released and slight compression was applied via the Caspar distractor to facilitate seating of the implant teeth into the vertebrae. AP and lateral fluoroscopy was used to confirm final implant position (Figure 2).

Bottom Line: 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.Overall success rates were 73.6% for TDR and 65.3% for ACDF, confirming non-inferiority (p < 0.0025).Level I.

View Article: PubMed Central - PubMed

Affiliation: Texas Back Institute, Denton, TX.

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.

No MeSH data available.


Related in: MedlinePlus