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 |