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Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

Study acronym: PRISCOPRO
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. 4 versions Re-verified since Oct 7, 2022, no change to tracked fieldsv5-v8
  2. Start date changed from estimate of Apr 27, 2021 to Apr 30, 2021v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 2021 to Apr 27, 2021
    • Site details revised at 2 of 2 sites
    • Study title expanded, about 4 words
    v3
  4. Secondary endpoints: details revised at 2 of 6 entriesv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. When brace treatment for scoliosis is indicated, standard treatment consists of bracing 20 hours or more per day. Outcomes of brace treatment depend to a large extent on wearing time and since many adolescents feel uncomfortable in the brace, it is of importance to combine efficacy and comfortability of the brace.
Trial Details
NCT Number NCT04805437
Lead Sponsor Karolinska Institutet
Collaborators: Linkoeping University
Conditions
(from sponsor)		 Idiopathic Scoliosis
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov