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Table 1 Schedule for screening and follow-up of included participants

From: The effect of concentrated bone marrow aspirate in operative treatment of fifth metatarsal stress fractures; a double-blind randomized controlled trial

Screening and Follow-Up Clinical and Radiographic Exams

Action

Pre-operative

Intra-operative

Follow-Up Visit (biweekly 2-14 weeks)

Follow-Up Visit Until Union (biweekly) (>14 weeks, determined by physician)

6 month follow-up visit

1 year Follow-Up visit

Information letter

X

     

Obtain written informed consent

X

     

Complete eligibility checklist

X

     

Complete medical history and baseline characteristics (form)

X

     

Complete physical examination (form)

X

 

X

X

X

X

Surgery

 

X

    

- Operative form (surgical information)

 

X

    

- cB + cBMA preparation and administration

 

X

    

- Bone biopsy fracture site

 

X

    

Lab assessments

X

     

Questionnaires

X

 

X

 

X

X

Radiographic assessment

X

X

X

X

X

X

Complication (form)

X

X

X

X

X

X

Adverse events, withdrawals & re-operation (form)

X

X

X

X

X

X