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Table 1 SPIRIT table

From: Surgical treatment of neuromuscular Early Onset Scoliosis with a bilateral posterior one-way rod compared to the Spring Distraction System: study protocol for a limited-efficacy Randomized Controlled Trial (BiPOWR)

 

STUDY PERIOD

Enrolment

Allocation

Surgery

Post-allocation

TIMEPOINT**

-t2

Before -2 weeks

-t1

-2 weeks

t0

Day of surgery

t1

 + 1 week

t2

 + 4 weeks

t3

3 months

t4

6 months

t5

12 months

Enrolment

 Eligibility screen

X

       

 Informed consent

X

       

 Allocation

 

X

      

Interventions

 Spring Distraction System

  

Implant in Situ

Implant in Situ

Implant in Situ

Implant in Situ

Implant in Situ

Implant in Situ

 One Way Self-Expanding Rod

  

Implant in Situ

Implant in Situ

Implant in Situ

Implant in Situ

Implant in Situ

Implant in Situ

Outcomes

 Main coronal Cobb angle

X

  

X

X

X

X

X

 Serious Adverse Events

  

X

X

X

X

X

X

 Implant length

   

X

X

X

X

X

 EOSQ-24 questionnaire

X

  

X

X

X

X

X