Timepoint** | Study period | ||||
---|---|---|---|---|---|
Screening | Allocation | Follow-up visits | Close-out | ||
Day − 21 to 0 | day 0 | Safety follow-up visit Day 2–7 (inclusive) | Week 6 ± 7 days | Month 6 ± 30 days | |
Enrolment: | |||||
Eligibility screen | X | ||||
Informed consent | X | ||||
Focused physical exam | X | X | X | X | |
Randomization / Allocation | X | ||||
Interventions: | |||||
Autologous Adipose Tissue Injection | X | ||||
Hyaluronic Acid Injection | X | ||||
Assessments: | |||||
WOMAC | X | X | X | X | |
WOMAC-A (contralateral knee) | X | X | X | X | |
PROMIS-29 | X | X | X | ||
Force Plate Analysis (bilateral) | X | X | X | ||
Clinical anchors | X | X | X | ||
Synovial fluid aspiration | X | X | X |