Table 1.
Study Flow Chart
| Evaluations | Baseline/Day1 | Day 7 | Day 14 | Day 30 | Day 90 | Day 356 Day |
|---|---|---|---|---|---|---|
| Informed Consent | X | |||||
| Medical History | X | |||||
| Vital Signs and Physical Exam | X | |||||
| X-Ray Evaluation | X | |||||
| Patients VAS of pain at rest | X | X | X | X | X | X |
| Patients VAS of pain after grip assessment | X | X | X | X | X | X |
| Patients global assessment of elbow injury | X | X | X | X | X | X |
| Patients assessment of normal function/activity | X | X | X | X | X | X |
| Physician's global assessment of elbow injury | X | X | X | X | X | X |
| Patients/physician satisfaction assessment | X | X | X | X | X | |
| Time to return to pain and disability-free sport | X | X | X | X | ||
| HA or placebo Administration | X | X | ||||
| Concomitant Medications | X | X | X | X | X | X |
| Adverse Events | X | X | X | X | X |