Parameter Period Value Source
1. Health State (Level of Disability) at Index
Minimal Initial State 0% RCT (SF-12)
Moderate Initial State 4%
Severe Initial State 27%
Crippled Initial State 39%
Bedbound Initial State 30%
2. Distribution of AE
TLIF TOPS™ RCT (AE and SE)
Minimal Serious 1.12% 2.00%
Nonserious 7.87% 4.00%
Moderate Serious 0.00% 2.35%
Nonserious 2.86% 3.53%
Severe Serious 13.04% 2.56%
Nonserious 4.35% 20.51%
Crippled Serious 11.11% 26.67%
Nonserious 16.67% 33.33%
Bedbound Serious 25.00% 0.00%
Nonserious 25.00% 100.00%
3. Distribution of Subsequent Action Following AE Type
TLIF TOPS™ RCT (AE and SE)
Minimal Serious—Supplemental Procedures 100.00% 77.78%
Serious—Surgery 0.00% 22.22%
Nonserious—Supplemental Procedures 92.86% 94.44%
Nonserious—Surgery 7.14% 5.56%
Moderate Serious—Supplemental Procedures 0.00% 0.50%
Serious—Surgery 0.00% 0.50%
Nonserious—Supplemental Procedures 100.00% 100.00%
Nonserious—Surgery 0.00% 0.00%
Severe Serious—Supplemental Procedures 66.67% 100.00%
Serious—Surgery 33.33% 0.00%
Nonserious—Supplemental Procedures 100.00% 100.00%
Nonserious—Surgery 0.00% 0.00%
Crippled Serious—Supplemental Procedures 50.00% 62.5%
Serious—Surgery 50.00% 37.5%
Nonserious—Supplemental Procedures 100.00% 100.00%
Nonserious—Surgery 0.00% 0.00%
Bedbound Serious—Supplemental Procedures 100.00% 0.00%
Serious—Surgery 0.00% 0.00%
Nonserious—Supplemental Procedures 100.00% 100.00%
Nonserious—Surgery 0.00% 0.00%