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Description Allocation 93 were enrolled
75 received intervention
18 did not receive intervention2 denied insurance coverage
8 changed their minds
3 were no longer surgical candidates at time of surgery
5 were treated off protocol
2 y 73 were evaluated (97.1% follow-up) 2 secondary surgical interventions (included in primary composite endpoint, excluded from secondary analyses)
5 y 56 were evaluated (74.7% follow-up) 5 secondary surgical interventions (included in primary composite endpoint, excluded from secondary analyses)
1 death
18 were lost to follow-up
- Table 2
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).
ODI score n Mean (SD) % Change (SD) Baseline 75 62.7 (10.3) — 2 y 71 39.8 (24.3) −37.8% (36.0%) 5 y 51 36.2 (25.7) −43.8% (37.1%) NOTE. The Wilcoxon test was used to compare baseline data; t tests were used to compare 24- and 60-month percent improvement.
SF-36 PCS score n Mean (SD) % Change (SD) Baseline 74 30.9 (5.6) — 2 y 70 38.8 (11.3) 29.8% (40.9%) 5 y 51 40.1 (13.6) 29.9% (43.7%) NOTE. The Wilcoxon test was used to compare baseline data; tests were used to compare 2-and 5-year percent improvement
VAS pain score n Mean (SD) % Change (SD) Baseline 73 74.9 (14.7) — 2 y 71 43.3 (31.6) −42.4% (42.9%) 5 y 51 40.0 (32.1) −47.5% (43.8%) NOTE. The Wilcoxon test was used to compare baseline data; tests were used to compare 24-and 60-month percent improvement.