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


OBJECTIVE
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.
McAfee
Paul C
PC
Spine and Scoliosis Center, St. Joseph's Hospital, Baltimore, Maryland, Towson, MD 21204, USA. mack8132@aol.com
Fedder
Ira L
IL
Saiedy
Samer
S
Shucosky
Erin M
EM
Cunningham
Bryan W
BW
D000328:Adult; D019643:Arthroplasty, Replacement / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007405:Intervertebral Disc Displacement / Q000601:surgery*; D008159:Lumbar Vertebrae / Q000601:surgery; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012107:Research Design; D013123:Spinal Fusion; D013997:Time Factors; D016896:Treatment Outcome