A retrospective clinical data analysis.
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.
Early successful clinical results of lumbar TDR have been reported. However, few reports have published its therapeutic effectiveness in the long term.
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.
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.
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: firstname.lastname@example.org
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.