Abstract
Background
We present the results of a single centre, prospective study to evaluate the clinical and radiographic outcomes of anterior cervical decompression and replacement (ACDR) using the NuNec(tm) Cervical Arthroplasty System (Pioneer Surgical Technology, Marquette, Mich., USA).
Methodology and Results
36 patients with radiculopathy/myelopathy, who failed to respond to conservative measures, were included. Pain and function were evaluated by Visual Analogue score for Neck pain (VAS-NP) and Arm pain (VAS-AP), Neck disability index (NDI) and SF-36 questionnaires. Radiological assessments include assessing overall range of movement (ROM) and at functional segment unit (FSU). Statistical analysis was completed using SPSS 16.0 statistical package (SPSS Inc, Chicago, IL). Appropriate parametric (A paired t-test) and non parametric tests (Wilcoxon signed-rank test) were used to assess the statistical significance (p<0.05).
The average age at operation was 51 years (range 35 - 77years). 8 patients received ACDR at one-level, 15 had 2-level surgery, 12 had 3-level surgery and 1 had a 4-level surgery. At the time of final follow-up (Mean 14.25 months, Range 12- 22.5 months) the mean NDI improved from 49.35; to 33.78 (p< 0.001). There statistically significant improvement note in VAS-NP (Post-op3.65, Pre-op:8.16, p<0.001), VAS-AP (Post-op:3.12, Pre-op:7.32, p<0.001) and SF-36BP (pre-op:29.15, post-op:37.18, p<0.002). The overall global ROM movement was preserved (pre-op:46.80±10.52, post-op:45.04±11.53) and an improvement in ROM at FSU was observed (pre-op:16.60±8.50, post-op:20.22±12.22) at final follow–up.
Conclusion
Our results of ACDR using the NuNec(tm) disc show statistically significant improvement in the outcome measures that are comparable to other types of ACDR. In addition, preservation of global cervical spine ROM and improvement in FSU ROM was observed despite single or multiple levels ACDR. Furthermore, NuNec(tm) ACDR gives excellent quality MR image during post-operative period. In our preliminary results, we report that NuNec(tm) ACDR device is safe, effective and has added design benefits.
