Study Design. A retrospective clinical data analysis.
Objective. To determine the therapeutic effectiveness of lumbar total disc replacement (TDR) using ProDisc-L (Synthes Spine, West Chester, PA) in the patients with degenerative disc diseases (DDD) with a minimum follow-up of 5 years.
Summary of Background Data. Early successful clinical results of lumbar TDR have been reported. However, few reports have published its therapeutic effectiveness in the long term.
Methods. The patients were examined preoperatively and at 3 months, 1 year, 2 years, and more than 5 years postoperatively, and assessed using visual analog scale (VAS), Oswestry disability index (ODI), physical health component summary (PCS) of the 36-Item Short Form Health Survey questionnaire, and sporting activity scale scores. At last follow-up visits, two additional questions were asked: satisfaction with surgery and willingness to undergo the same treatment. Finally, clinical success was assessed using the Food and Drug Administration definition.
Results. Thirty-five patients were included in the study. The mean follow-up period was 72 months (6 years). Postoperatively, all outcome measure scores (VAS, mean ODI, PCS, and sports activity scores) immediately improved and these improvements were maintained at last follow-up visits with statistical significance. However, outcome score improvements were observed to be slightly, though significantly, lower at last follow-up visits than at 1 or 2 years postoperatively. Eighty-eight percent of patients were “satisfied” or “somewhat satisfied” with treatment and 60% were prepared to undergo the same treatment again. Twenty-five patients (71.4%) achieved clinical success.
Conclusion. This study reveals that lumbar TDR using ProDisc-L is a safe and effective treatment for chronic back pain caused by lumbar DDD as assessed at more than 5 years postoperatively. Nevertheless, outcome scores were slightly, though significantly lower at last follow-up visits than at 1 and 2 years postoperatively. A longer-term follow-up study is warranted.
This retrospective clinical study reveals that lumbar total disc replacement using ProDisc-L is an effective treatment for lumbar degenerative disc diseases as assessed at more than 5 years postoperatively. However, the slight decline in outcome scores observed beyond approximately 2 years after surgery appears to be significant.
From the Department of Neurosurgery, Seoul St. Mary Hospital, The Catholic University, Seoul, South Korea
Address correspondence and reprint requests to Kyeong-Sik Ryu, MD, PhD, Department of Neurosurgery, Seoul St. Mary's Hospital, 505 Banpo-Dong, Seocho-Gu, Seoul, 137-701, South Korea; E-mail: email@example.com
Acknowledgment date: April 28, 2011; First revision date: July 13, 2011; Acceptance date: July 19, 2011.
The manuscript submitted does not contain information about medical device(s)/drug(s).
No funds were received in support of this work.
No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.