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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

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.
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Figure 0003: 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.

Mentions: The primary composite endpoint assessed individual patient success as demonstrated by functional improvement (NDI), no need for subsequent surgical intervention (removal, revision, supplemental fixation, reoperation), and the absence of study defined major complications including neurologic deterioration, CEC-assessed adverse events, and radiographic failure. The composite success rate for TDR patients was 73.7% at month 24, compared to 65.3% success rate for ACDF (Figure 3). The composite endpoint results establish TDR non-inferiority for the primary endpoint (p = 0.0021). Additionally, TDR patients tended to achieve success earlier than ACDF patients. At 6 month time point, 75.0% of TDR patients achieved composite success, compared with 41.4% of ACDF patients (Figure 4).


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)

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.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 0003: 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.
Mentions: The primary composite endpoint assessed individual patient success as demonstrated by functional improvement (NDI), no need for subsequent surgical intervention (removal, revision, supplemental fixation, reoperation), and the absence of study defined major complications including neurologic deterioration, CEC-assessed adverse events, and radiographic failure. The composite success rate for TDR patients was 73.7% at month 24, compared to 65.3% success rate for ACDF (Figure 3). The composite endpoint results establish TDR non-inferiority for the primary endpoint (p = 0.0021). Additionally, TDR patients tended to achieve success earlier than ACDF patients. At 6 month time point, 75.0% of TDR patients achieved composite success, compared with 41.4% of ACDF patients (Figure 4).

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