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Table 3 Outcome assessments experimental phase B

From: Autologous bone marrow expanded mesenchymal stem cells in patellar tendinopathy: protocol for a phase I/II, single-centre, randomized with active control PRP, double-blinded clinical trial

Study period

 

Enrollment

Treatment

Follow-up

Timepoints

 

0

23 days

1 weeks

2 weeks

3 weeks

6 weeks

8 weeks

10 weeks

3 months

18 weeks

6 months

12 months

IC

 

X

             

Preop + serology

  

X

            

Physicalexam

X

X

   

X

X

X

X

X

X

X

X

X

X

VAS

 

X

   

X

X

X

X

X

X

X

X

X

X

VISA-P

 

X

   

X

X

X

X

X

X

X

X

X

X

blood test

           

X

   

BM

   

X

           

MSV

    

X

          

Bloodbank

   

X

           

MRI

 

X

         

X*

X

X

X

Ultrasound

 

X

   

X

X

X

X

X

X

X

X

X

X

UTC

  

X

    

X

 

X

 

X

X

X

X

DYN

  

X

    

X

 

X

 

X

X

X

X

AE

   

X

X

X

X

X

X

X

X

X

X

X

X

Medication

   

X

X

X

X

X

X

X

X

X

X

X

X

  1. VAS visual analog scale; VISA-P Victorian Institute of Sport Assessment (Patellar); BM bone marrow harvest; MSV injection of MSV; MRI magnetic resonance imaging; UTC ultrasound tissue characterization; DYN dynamometry, PreOp preoperative study, AE adverse Events.
  2. X* this MRI test will establish the status of the healing process at 3 months.