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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