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Experimental design of total disk replacement-experience with a prospective randomized study of the SB Charitè
Paul C McAfee1, Ira L Fedder, Samer Saiedy
1Spine and Scoliosis Center, St. Joseph's Hospital, Baltimore, Maryland, Towson, MD 21204, USA. mack8132@aol.com
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.
