Experimental design of total disk replacement-experience with a prospective randomized study of the SB Charitè.

Autor:	McAfee PC; Spine and Scoliosis Center, St. Joseph's Hospital, Baltimore, Maryland, Towson, MD 21204, USA. mack8132@aol.com, Fedder IL, Saiedy S, Shucosky EM, Cunningham BW
Jazyk:	angličtina
Zdroj:	Spine [Spine (Phila Pa 1976)] 2003 Oct 15; Vol. 28 (20), pp. S153-62.
DOI:	10.1097/01.BRS.0000092217.34981.E1
Abstrakt:	Study Design: Prospective randomized clinical trial. Objectives: To determine if a prospective randomized study of patients with symptomatic degenerative disc disease treated with disc arthroplasty could be safely completed. Methods: Sixty patients with one-level discogenic pain confirmed by plain radiography, magnetic resonance imaging, and provocative discography for degenerative disc disease were randomized comparing 1/3 BAK anterior interbody fusion and 2/3 anterior SB Charitè artificial disc replacement. Results: The mean age was 40.3 years (range 21-56 years). Nineteen cases were at L4-L5 and 41 cases were at L5-S1. Nineteen cases had BAK anterior interbody fusion and 41 cases were randomized as SB Charitè disc replacement. The length of surgery was mean 88.4 minutes (range 54-137 minutes) for both groups. The estimated blood loss was mean 289.5 cc (range 50-1800 cc). The length of hospital stay was a mean of 3.03 days (range 2 to 6 days). Oswestry Disability Index for the BAK control group was 45.9 +/- 10.4 before surgery and 23.5 +/- 17.2 at follow-up (P < 0.001). The corresponding ODI scores for the SB Charitè disc were 50.0 +/- 14.3 before surgery and 25.0 +/- 20.1 at a mean of 2 years' follow-up (P < 0.001). Conclusions: This is the first study that shows improvement of functional outcome measures in a prospective randomized design treating primarily mechanical back pain and achieving comparable successful results to lumbar spinal stenosis decompression.
Databáze:	MEDLINE
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