gms | German Medical Science

Objective: This ongoing study portrays clinical outcome of 17 patients implanted with Cerkinetic TDR for treatment of cervical mono segmental degenerative disc disease over two years.

Method: From June 2009 to June 2011, 17 patients suffering from radiologically confirmed mono segmental herniated degenerated cervical disc (DDD) with no remission of symptoms after six weeks conservative treatment were implanted with Cerkinetic cervical TDR. Patients' clinical status was assessed pre and postoperatively by neurological examination, Neck Disability Index (NDI), neck and arm Visual Analogue Scale (VAS), patient satisfaction survey, and radiological imaging. Ongoing postoperative assessment is performed at 1 week, 3, 6, 12 and 24 months respectively. Radiological evaluation in follow-up visits is performed at 1 week, 3, 12 and 24 months, respectively.

Results: Procedure was successfully performed in all patients (9 male, 8 female), mean age 46 years, (range 33–53). All patients attended follow-up visits. Ongoing follow-up is based on individual procedure dates, until the period of 24 months follow-up is completed for all patients. Current mean follow-up period is 11.25 months (range 3 weeks – 24 months). Patients preoperative mean NDI was 64% (crippled). Mean postoperative NDI is 17.5% (minimal). Preoperative mean neck pain VAS was 8.5 and this was decreased to 1.5 postoperatively. Mean preoperative arm pain VAS was 8 and decreased at post operative follow-up to 1.3. Neck range of motion (ROM) at follow-up was back to normal (axial rotation 80°, lateral bending 45° and flexion 60°/extension 75° ± 10% of these ROM values). Correlative radiologically assessment documented full functioning of implanted TDR in all subjects without signs of dislocation, subsidence or heterotopic ossification. Patients' satisfaction was 10 out of 1–10 satisfaction scale. No device failure was observed. No adverse events had occurred.

Conclusions: Based on these results of 17 patients implanted over a two years period, Cerkinetic is a safe and effective artificial TDR in treatment of single segmental cervical DDD. Results indicate maintenance of cervical disc height, motion stability and neck sagittal profile. Patients follow-up manifests pain relief and improved quality of life. Further study is recommended in order to establish a larger statistical database.