Clinical research of double-way connection intervertebral fusion device(ROI-C) for anterior cervical discectomy and fusion

English Keywords:Cervical myelopathy  Anterior cervical discectomy and fusion(ACDF)  Double-way connection intervertebral fusion device(ROI-C)  Clinical efficacy

English Abstract:

  【Abstract】 Objectives: To compare the clinical efficacy of double-way connection intervertebral fusion device (ROI-C) or traditional cage with titanium plate in the treatment of cervical myelopathy, analysis of ROI-C in the clinical efficacy of anterior cervical operation application. Methods: From June 2011 to December 2013, a total of 104 patients with the cervical myelopathy was treated with ACDF or ROI-C in our department. The double-way connection intervertebral fusion device(ROI-C) was applied in 46 patients with a total of 89 segments as group A. Cage and titanium plate implantation were used in 58 patients with 106 segments as group B. Antero-posterior and lateral X-rays, flexion-extension X-ray, CT scan and MRI were performed preoperatively. Antero-posterior and lateral X-rays were performed 3 days, 3 months, 6 months and 12 months after operation. Flexion-extension X-rays were made 3 months, 6 months and 12 months postoperatively. Operation time, intraoperative blood loss, incidence of postoperative dysphagia, JOA scores and VAS scores, Cobb angle, the height of intervertebral space, fusion rate and complications were observed in both groups. Results: Patients were followed up for 3 to 36 months, averaging 18 months. The operation time in group A was 73.2±8.1min for single level, 127.4±13.4min for two levels, 152.7±19.4min for three levels; the amount of bleeding was 62.3±20.2ml for single level, 83.2±32.4ml for 2 levels, 110.5±54.3ml for 3 levels, all were significantly lower than those of group B(operation time: 84.3±7.2min for single level, 147.6±13.1min for two levels, 184.1±21.3min for three levels; the amount of bleeding: 100.2±22.1ml for single level, 128.3±35.3ml for 2 levels, 190.6±57.2ml for 3 levels), the differences were statistically significant(P<0.05). In group A, preoperative and postoperative JOA score was 9.49±0.83 and 12.45±1.00 respectively, while 9.21±1.00 and 12.04±0.89 in group B, postoperative JOA score improved significantly compared with preoperative ones(P<0.05). In group A, preoperative and postoperative VAS score was 2.94±0.56 and 1.24±0.44 respectively, while 2.88±0.54 and 1.26±0.43 in group B, postoperative VAS score improved significantly compared with preoperative ones(P<0.05), while no difference was noted between two groups either before or after operation(P>0.05). In group A, preoperative and postoperative Cobb angle was 20.35°±7.12° and 26.82°±6.13° respectively, while 18.34°±7.32° and 25.32°±8.91° in group B, postoperative cervical lordosis(Cobb angle) was better than that of preoperation(P<0.05), but no significant difference was noted between two groups(P>0.05). In group A, preoperative and postoperative intervertebral height was 5.83±1.02mm and 8.47±1.83mm respectively, while 5.54±1.82mm and 8.03±2.43mm in group B, postoperative intervertebral height was higher than that of preoperation(P<0.05), while no significant difference was noted between two groups(P>0.05). In group A, postoperative dysphagia occurrence rate was 6.52%, only 3 cases of 46 patients suffered from mild dysphagia and were relieved in 1 month. In group B, postoperative dysphagia occurred in 34.48% of patients, in 58 patients, mild dysphagia was noted in 13 cases, moderate dysphagia in 7 cases. Dysphagia rate in group A was obviously lower than that in group B(P<0.05). At final follow-up, 45 patients in group A got bony fusion, with the fusion rate of 97.8%; 55 cases in group B got bony fusion, with the fusion rate of 94.8%; no significant difference was noted between the two groups(P>0.05). No tracheal, esophageal injury or recurrent laryngeal nerve injury was noted in 2 groups. Conclusions: Cervical intervertebral fusion cage bridge shaped locking(ROI-C) can effectively restore cervical lordosis and intervertebral height, can obtain satisfactory rate of fusion, the operation is relatively simple, short operation time, intraoperative bleeding is less, less tissue injury, postoperative dysphagia occurrence rate is low, is expected to replace the anterior cage combined with titanium plate fixation for treatment of cervical spondylosis fusion operation.