[Artificial Disc Replacement] Clinical outcome of the Dynardi dynamic artificial disc: 6 months preliminary results

[Justin]

Surgical Neurology
Volume 72, Issue 5, November 2009, Page 515

Clinical outcome of the Dynardi dynamic artificial disc: 6 months preliminary results

F. Schils MDa, A. Kirgis MDb, A. Sporns MDc, C. Etter MDd, G. Veeckmans MDe, O. Schwarzenbach MDf and J. Bleyen MDg. aClinique St Joseph Liège, Belgium. bOCM Munich, Germany. cHKS, Schwerin, Germany. dKlinik im Schachen, Aarau, Switzerland. eSt Dymphna, Geel, Belgium. fRuckenzentrum, Thun, Switzerland. gA.Z Maria Middelares, Gent, Belgium. © 2009 Published by Elsevier Inc.

Introduction

Preliminary clinical evaluation of a new lumbar disc prosthesis. Prospective multicenter study.

Material and methods

• Results for patients who reached a minimum 6 months follow-up (N = 51) and complications for all patients (N = 72) are reported.
  
• Inclusion criteria were discogenic low back pain, one or two segments and failed conservative treatment (6 months).
  
• Exclusion criteria were: poor bone quality, deformities, facet joint arthrosis, posterior instability, fractures, spondylodiscitis and degenerative spondylolisthesis.
  
• The Dynardi was implanted via retro- or transperitoneal approach. Results were collected preoperatively, 6 weeks and 6 months after surgery. For clinical outcomes, the Oswestry Disability Index (0-100%) and back and leg pain on the Visual Analog Scale (0-10) were documented. Wilcoxon test was used for statistics.

Results

• 51 patients (28 females, 23 males) were analyzed. Mean age was 43.7 years (24-65). Diagnoses were DDD with herniation (53%) and DDD only (47%). The treated levels were L4-L5 (23%), L5-S1 (67%) and L4-L5/L5-S1 (10%).
  
• 2 adverse events not device-related were described (blood vessel damage resolved during surgery, radiculopathy treated by microdecompression 6 weeks post-surgery). One case of subsidence was reported after 6 weeks.
  
• Mean ODI decreased significantly from 45% preop to 25% at 6 weeks (P < .001) and 16% six months postoperatively (P < .001). Average back pain improved significantly from 6.8 preop to 2.4 6 weeks postoperatively (P < .001) and 1.9 at 6 months (P < .001).
  
• Average leg pain dropped from 4.5 preop to 2.4 and 1.2 at 6 weeks and 6 months (P < .001).

Conclusion

Although the preliminary results of the Dynardi are promising, more data are required to determine whether the clinical success continues in the long term.

Total disc replacement; Lumbar; Dynardi dynamic artificial disc

[JK2234]

I just seen a pic of this disc on google images...