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Table 1 Study Calendar

From: A randomized, controlled study to evaluate the efficacy of intra-articular, autologous adipose tissue injections for the treatment of mild-to-moderate knee osteoarthritis compared to hyaluronic acid: a study protocol

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
  1. The eligibility screen includes a detailed physical exam/medical history and pregnancy testing (if applicable). The focused physical exam includes Height/weight/vitals, concomitant medications, knee exam, and wound evaluation (if applicable). Only patients that receive the fat treatment will be asked to come in for the safety follow-up. All assessments pertain only to the study knee, unless otherwise indicated