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Table 1 Summary of trial-specific interventions and documentation

From: Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID): protocol for a randomized clinical multi-center trial

 

V1

V2

V3

V4

V5

V6

 

Baseline

Treatment

1 d post-intervention

2 w post-intervention

3 mo post-intervention

12 mo final F/U

Assessment

LI

LI, RA

LI, RA, SR

LI, RA, SR

LI, RA, SR

LI, RA, SR

Entry criteria

X

     

Randomization

X

     

Radiographs

X

X

X

X

X

optional

SF-36

    

X

X

EQ-5D

  

X

 

X

X

DASH

    

X

X

Wrist ROM

    

X

X

Complications

 

X

X

X

X

X

SAE

 

X

X

X

X

X

  1. LI = local investigator, RA = research assistant/study nurse, SR = patient self report