Limits...
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 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 < 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
getmorefigures.php?uid=PMC4325486&req=5

Figure 0006: 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 < 0.05) * Denotes significant difference determined using unpaired t-test to compare the change from baseline between the two treatments (p < 0.05).

Mentions: VAS assessments were recorded for the intensity of both neck and arm pain. Neck and arm pain decreased significantly both groups at all time points when compared to baseline (p < 0.001; Figure 6). The mean change in VAS neck pain score from baseline to follow- up visit was greater for the TDR group than for the ACDF group at every follow-up time point, however the difference was statistically significant only at the 6 week visit (p = 0.0072). Mean neck pain improvement at 24 months was similar between the two groups (17.34 for TDR; 19.36 for ACDF). A similar trend was seen for arm pain scores: mean score change from baseline to follow-up visit was greater for the TDR group than the ACDF group at each visit and mean arm pain scores at 24 months were similar between the two groups (13.6 for TDR; 13.5 for ACDF), when analyzing the arm with the worst score at baseline.


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 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 < 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 0006: 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 < 0.05) * Denotes significant difference determined using unpaired t-test to compare the change from baseline between the two treatments (p < 0.05).
Mentions: VAS assessments were recorded for the intensity of both neck and arm pain. Neck and arm pain decreased significantly both groups at all time points when compared to baseline (p < 0.001; Figure 6). The mean change in VAS neck pain score from baseline to follow- up visit was greater for the TDR group than for the ACDF group at every follow-up time point, however the difference was statistically significant only at the 6 week visit (p = 0.0072). Mean neck pain improvement at 24 months was similar between the two groups (17.34 for TDR; 19.36 for ACDF). A similar trend was seen for arm pain scores: mean score change from baseline to follow-up visit was greater for the TDR group than the ACDF group at each visit and mean arm pain scores at 24 months were similar between the two groups (13.6 for TDR; 13.5 for ACDF), when analyzing the arm with the worst score at baseline.

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