Table 4.
Comparisons of efficacy and neurological variables at 84 months.
| Measure | P1 (Investigational) | P0 (Control) | P0 – P1 | Probability of Superiority | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| % Investigational | % Control | Mean | 95% HPD | Mean | 95% HPD | Mean | 95% HPD | Non-inferiority | Superiority | |
| NDI | 86.06% (179/208) | 80.11% (145/181) | 0.862 | (0.810, 0.908) | 0.801 | (0.735, 0.859) | -0.061 | (-0.144, 0.020) | ∼1.000 | 0.932 |
| Neurological status | 92.75% (192/207) | 79.67% (145/182) | 0.927 | (0.887, 0.959) | 0.800 | (0.737, 0.858) | -0.127 | (-0.201, -0.055) | ∼1.000 | ∼1.000 |
| FSU | 83.65% (133/159) | 96.85% (123/127) | 0.827 | (0.761, 0.885) | 0.973 | (0.940, 0.993) | 0.146 | (0.079, 0.217) | 0.093 | 0.000 |
| Neck pain | 94.69% (196/207) | 95.56% (172/180) | 0.945 | (0.908, 0.972) | 0.961 | (0.928, 0.984) | 0.016 | (-0.029, 0.060) | ∼1.000 | 0.234 |
| Arm pain | 94.20% (195/207) | 92.78% (167/180) | 0.945 | (0.908, 0.972) | 0.927 | (0.884, 0.961) | -0.018 | (-0.072, 0.033) | ∼1.000 | 0.748 |
| SF-36 PCS | 85.29% (174/204) | 79.21% (141/178) | 0.851 | (0.797, 0.898) | 0.797 | (0.732, 0.856) | -0.053 | (-0.137, 0.028) | ∼1.000 | 0.894 |
| SF-36 MCS | 77.45% (158/204) | 70.22% (125/178) | 0.786 | (0.724, 0.840) | 0.690 | (0.616, 0.758) | -0.095 | (-0.192, 0.0001) | ∼1.000 | 0.975 |
| Overall success (w/o FSU) | 74.88% (158/211) | 63.19% (115/182) | 0.746 | (0.683, 0.804) | 0.637 | (0.563, 0.709) | -0.109 | (-0.208, -0.011) | ∼1.000 | 0.985 |
| Overall success (w/FSU) | 62.05% (103/166) | 60.00% (81/135) | 0.612 | (0.533, 0.688) | 0.611 | (0.520, 0.696) | -0.001 | (-0.125, 0.122) | 0.947 | 0.508 |
FSU = functional spinal unit, HPD = highest posterior density, MCS = Short Form-36 Mental Component Summary, NDI = Neck Disability Index, SF-36 PCS = Short Form-36 Physical Component Summary.