Demographics and baseline characteristics of all patients enrolled and treated on protocol
| Data (n 75) | |
|---|---|
| Age at surgery [mean (SD)] (y) | 40.4 (7.6) |
| Male [n (%)] | 34 (45.3%) |
| Race [n (%)] | |
| White | 59 (78.7%) |
| African American | 5 (6.7%) |
| Hispanic | 10 (13.3%) |
| Asian American | 0 (0.0%) |
| Other | 1 (1.3%) |
| Smoking status | |
| Never | 34 (45.3%) |
| Former | 17 (22.7%) |
| Current | 24 (32.0%) |
| Body mass index [mean (SD)] (kg/m2) | 27.3 (4.4) |
| ODI score [mean (SD)] (out of 100) | 62.7 (10.3) |
| Narcotic use as prior treatment [n (%)] | 57 (76.0%) |
| Engaged in recreational activity [n (%)] | 37 (49.3%) |
| Implant level [n (%)] | |
| L3-L4 | 3 (4.0%) |
| L4-L5 | 22 (29.3%) |
| L5-S1 | 50 (66.7%) |
| Prior surgical treatment [n (%)] | 23 (30.7%) |
NOTE. Continuous and ordinal variables were analyzed by a Wilcoxon rank sum test; categorical variables were analyzed with the Fisher exact test to compare Fusion single level Randomized patients (F1R) with Pro- Disc-L single level Randomized patients (P1R).