Table 1 Time and Events Schedule
Base-line | Intra-OP | Discharge | Follow-up Period from Surgery Date (± Days) | ||||||
|---|---|---|---|---|---|---|---|---|---|
6 wks (± 14) | 3 mon (± 14) | 6 mon (± 30) | 12 mon (± 60) | 24 mon (± 60) | 3-5 yrs (± 60) | ||||
Inclusion/Exclusion Determination | X | ||||||||
Osteoporosis/ osteopenia screen | X | ||||||||
Medical History/Physical Exam | X | ||||||||
Work Status | X | X | X | X | X | X | X | ||
Pain Medications | X | X | X | X | |||||
Antibiotics | X | X** | X | ||||||
Visual Analog Scale (VAS) Pain Assessment | X | X | X | X | X | X | X | ||
Neurological Assessment | X | X | X | X | X | X | X | X | |
DVT Prophylaxis | X | ||||||||
QOL SF-36 | X | X | X | X | X | X | X | ||
Oswestry Disability Index (ODI) | X | X | X | X | X | X | X | ||
Hospital Stay | X | ||||||||
Range of Motion | X | X | X | X | X | ||||
Subject Satisfaction | X | X | X | ||||||
Adverse Events | X | X | X | X | X | X | X | X | |
RADIOGRAPHIC EVENTS | |||||||||
MRI scan | X | ||||||||
DXA Scan | X (IR) | ||||||||
X-rays, A/P -- Standing Neutral | X | X (Implant Position) | X (Implant Position) | X | X | X | X | X | X |
X-rays, A/P- Right/Left Bending | X | X | X | X | X | X | X | ||
X-rays, Lateral - Flexion-Extension | X | X | X | X | X | X | X | ||
X-Rays, Lateral Standing Neutral | X | X (Implant Position) | X (Implant Position) | X | X | X | X | X | X |