2012년 10월 22일 월요일

Clinical outcome of lumbar total disc replacement using ProDisc-L in degenerative disc disease: minimum 5-year follow-up results at a single institute


Clinical Case Series
Spine (Phila Pa 1976). 2012 Apr 15;37(8):672-7.

Title: 
Clinical outcome of lumbar total disc replacement using ProDisc-L in degenerative disc disease: minimum 5-year follow-up results at a single institute

Authors
Park CK
Ryu KS
Lee KY
Lee HJ


Study Design. 

A retrospective clinical data analysis with minimum 50year follow-up results at a single institute


Objective

1. To observe longitudinal changes in clinical outcomes using several assessment measures

2. To determine the therapeutic efficacy of lumbar TDR (ProDic-L) in DDD patients


Summary of Background Data

1. Early successful clinical results of lumbar TDR have been reported. 

2. However, few reports have published its therapeutic effectiveness in the long term.


Methods

1. Patient examination
* Preoperatively
* 3 months, 1 year, 2 years and more than 5 years postoperatively

2. Questionnaires
* Visual analog scale (VAS)
* Oswestry disability index (ODI)
* Physical health component summary (PCS) of 36-Item short form
* Sporting activity scale scores

2.1. At last follow-up visits, 2 more questions
* Satisfaction with surgery
* Willingness to undergo the same treatment

3. Clinical success assessment by FDA definition


Results

1. Subjects: 35 patients

2. Mean follow-up period: 72 months (6 years)

3. All outcome measure scores (VAS, mean ODI, PCS, and sports activity scores) immediately improved.

4. These improvements were maintained at last follow-up with statistical significance.

5. However, improvements were observed to be slightly, though significantly, lower at last follow-up visits than at 1 or 2 years postoperatively. 

6. Results of 2 more questions
* Satisfied or somewhat satisfied: 88%
* Willingness to undergo the same treatment: 60%

7. Clinical success assessment: 71.4%


Conclusion

1. 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. 

2. 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.


Limitations

1. Just 1 center study with a single surgeon’s series

2. Retrospective nature and small cohort

3. Lack of a control group


Key points

Refer to conclusion. 


"This comes from Spine (c) 2012 Lippincott Williams & Wilkins, Inc."

Videos
1. Total Disc Replacement using ProDisc-L

2. Total Disc Replacement using ProDisc-L practice