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Indication and Treatment of Adult Kyphoscoliosis

Study acronym: INTRAKS
StatusUnknown
PhaseNot specified
Started
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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Trial status: Recruiting to Active, Not Recruitingv5 Show 4 more changesShow less
    • Enrollment target: estimated 300 to confirmed 120
    • Primary completion date changed from estimate of Jul 1, 2024 to Jan 1, 2024
    • Site details revised at 5 of 5 sites
    • Collaborators revised (5)
  3. Primary completion date: Jul 1, 2023 to Jul 1, 2024
    • Study completion date: Jan 1, 2025 to Jan 1, 2026
    v4
  4. Study description shortened, about 9 words
    • Eligibility criteria expanded, about 3 words
    v3
  5. Study description expanded, about 8 wordsv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Degeneration, iatrogenic-/idiopathic causes and fractures can lead to kypho- scoliotic deformities potentially resulting in pain and loss of function. The surgical strategies rely on surgeon preferences and type of deformity as well as clinical symptoms. The complication rate of surgical treatment is high. The aim of this study is to elucidate the indications for surgical treatment of kyphoscoliosis and evaluate the effectiveness of surgical and non-surgical outcome clinically and radiologically. The primary outcome for the PROMs and x-ray is at 12 months, but the investigators will also follow the patients with the PROMs and x-rays after 2,5 and 10 years.
Trial Details
NCT Number NCT04536909
Lead Sponsor University of Bergen
Collaborators: Oslo University Hospital, Kyoto University Hospital, Region Örebro County, Skane University Hospital, Haukeland University Hospital
Conditions
(from sponsor)		 Kyphoscoliosis
Related terms Congenital Abnormalities, Kyphosis, Scoliosis
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov