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Table 3 Schedule of study procedures

From: ARC (Australian Rotator Cuff) trial: study protocol for a randomised placebo-controlled trial comparing rotator cuff repair to no repair during arthroscopic shoulder surgery for people with shoulder pain and non-acute rotator cuff tears

 

Enrolment

Baseline

Visit 1 -Surgery

PS-1

1–2 weeks

PS-2

6–8 weeks

PS-3

3 months

PS-4

6 months

PS-5

12 months

PS-6

24 months

PS-7

5 years

PS-8

10 years

Informed consent

X

          

Inclusion / exclusion criteria

 

X

X

        

Copy of clinical MRI

 

X

     

Xa

   

Medical history/demographics

 

X

         

Surgery / randomisation

  

X

        

Operation reports

  

X

        

Surgeon follow up

   

X

X

X

X

X

X

  

Blinding fidelity

   

X

  

X

X

X

  

Shoulder strength

 

X

    

X

X

   

Work status

 

X

    

X

X

   

Physiotherapy attendance

      

X

    

Outcome questionnaires

 

X

    

X

X

X

X

X

AE/ SAE

/Complications

   

X

X

X

X

X

X

Xb

Xb

  1. PS post surgery
  2. a11–18 months
  3. bOnly complications will be recorded (not adverse events)
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Trials

ISSN: 1745-6215