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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

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 < 0.05) * Denotes significant difference determined using unpaired t-test to compare the change from baseline between the two treatments (p < 0.05).
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Figure 0005: 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 < 0.05) * Denotes significant difference determined using unpaired t-test to compare the change from baseline between the two treatments (p < 0.05).

Mentions: Baseline NDI scores for both treatment groups were not significantly different (54.0 for TDR and 54.1 for ACDF). Patients in both groups experienced significant improvement in NDI scores from baseline at all follow-up time points (Figure 5). The mean improvement in NDI from baseline was greater in the TDR group than the ACDF group at all time points and this difference was statistically significant at 6 weeks (p = 0.0141) and 3 months (p = 0.0026).


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)

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 < 0.05) * Denotes significant difference determined using unpaired t-test to compare the change from baseline between the two treatments (p < 0.05).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 0005: 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 < 0.05) * Denotes significant difference determined using unpaired t-test to compare the change from baseline between the two treatments (p < 0.05).
Mentions: Baseline NDI scores for both treatment groups were not significantly different (54.0 for TDR and 54.1 for ACDF). Patients in both groups experienced significant improvement in NDI scores from baseline at all follow-up time points (Figure 5). The mean improvement in NDI from baseline was greater in the TDR group than the ACDF group at all time points and this difference was statistically significant at 6 weeks (p = 0.0141) and 3 months (p = 0.0026).

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