Skip to main content

Table 1 Schedule of events (SPIRIT)

From: Fixation using alternative implants for the treatment of hip fractures (FAITH-2): design and rationale for a pilot multi-centre 2 × 2 factorial randomized controlled trial in young femoral neck fracture patients

Assessment

Screening

Enrollment (baseline)

Surgery

Post-operative

Week 6

Month 3

Month 6

Month 9

Month 12

Informed consent

X

        

Medical history

X

        

Anterior-posterior and lateral X-rays of proximal femur

X

  

X

X

X

X

X

X

Physical Exam/injury assessment

X

        

Screening form

X

        

Randomization form

 

X

       

Pre-operative form

 

X

       

Surgery (SHS or cancellous screws)

  

X

      

Surgical forms

  

X

      

Hospital discharge form

   

X

     

Vitamin D or placebo supplementationb

   

X

X

X

X

  

Follow-up visit forms

   

X

X

X

X

X

X

Assessment for re-operations

   

X

X

X

X

X

X

Assessment of fracture healing complications

    

X

X

X

X

X

Assessment of fracture healing

    

X

X

X

X

X

Hip Outcome Score (HOS)

   

Xa

X

X

X

X

X

Short-Form 12 (SF-12)

   

Xa

X

X

X

X

X

Radiographic Union Score for Hip (RUSH)

      

X

X

X

Assessment of fracture healing of the ipsilateral femoral shaft fracturec

    

X

X

X

X

X

Assessment for fracture-related adverse events

  

X

X

X

X

X

X

X

Assessment for serious adverse events

  

X

X

X

X

X

X

X

Assessment for planned re-operations

        

X

  1. aAsks about participant’s function prior to their hip fracture
  2. bNutritional supplementation will be administered upon hospital discharge or within 2 weeks of the participant’s surgery, whichever comes first. Ideally, participants should be administered the nutritional supplementation as soon as possible following their surgery to repair their femoral neck fracture
  3. cFor participants with an ipsilateral femoral shaft fracture