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Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease

Study acronym: IPSG1
StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Study sites: 47 to 46v14
  2. Study sites: 46 to 47
    • Collaborators: 43 to 44
    v13
  3. Study sites: 42 to 46
    • Collaborators: 40 to 43
    v12
  4. Trial status: Recruiting to Enrolling by Invitationv11 Show 6 more changesShow less
    • Study sites: 44 to 42
    • Interventions: multiple epiphyseal drilling (Procedure), osteotomy (Procedure) to Multiple Epiphyseal Drilling (Procedure), Nonoperative Observation (Procedure), Osteotomy + Long Term Non-Weight Bearing (Procedure)…
    • Eligibility criteria shortened, about 7 words
    • Study description shortened, about 173 words
    • Collaborators: 32 to 40
    • Study arms: 14 to 12
  5. Re-verified, no change to tracked fieldsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 41 to 44v9
  2. Site contacts updated at 1 of 41 sitesv8
  3. Enrollment target: 600 to 1500v7 Show 6 more changesShow less
    • Primary and study completion dates: Sep 2023 to Sep 2032
    • Eligibility criteria expanded, about 11 words
    • Study description expanded, about 123 words
    • Site contacts updated at 1 of 41 sites
    • Collaborators: 34 to 32
    • Study arms: 9 to 14
  4. Site details revised at 5 of 41 sitesv6
  5. Site contacts updated at 1 of 41 sites
    • Collaborators expanded, about 124 words
    v5
  6. Site details revised at 16 of 41 sitesv4
  7. Study sites: 40 to 41v3
  8. Site details revised at 2 of 40 sitesv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a significant public health problem (affects 1 in 740 boys between ages 0-14), but uncommon enough to have a sufficient number of patients from a single institution to perform a definitive prospective study comparing the results of current treatments. The present study will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP) Disease and collect information regarding their presentation, treatment, and outcomes in the course of receiving currently available treatments. This study seeks to compare the outcomes of current treatments in the management of different age groups (ages 1-6, 6-8, 8-11, \>11) of patients with Perthes disease at two- and five-year followup and at skeletal maturity. For each age group, two to three common treatment regimens currently used by practicing pediatric orthopaedic surgeons will be compared. The intervention a patient receives is determined through physician treatment expertise, and is not pre-determined by the study.
Trial Details
NCT Number NCT02040714
Lead Sponsor Texas Scottish Rite Hospital for Children
Collaborators: Alberta Children's Hospital, Alfred I. duPont Hospital for Children, Le Bonheur Children's Hospital, Children's Hospital Colorado, Children's Hospital Los Angeles, Children's National Research Institute, Children's Healthcare of Atlanta, Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, Columbia University, Connecticut Children's Medical Center, Gillette Children's Specialty Healthcare, Boston Children's Hospital, Johns Hopkins University, Kaiser Permanente, Kasturba Medical College, Montefiore Medical Center, Nationwide Children's Hospital, NYU Langone Health, OrthoCarolina Research Institute, Inc., University of Sao Paulo General Hospital, Seoul National University Childrens Hospital, Shriners Hospitals for Children, University Hospital Southampton NHS Foundation Trust, Baylor College of Medicine, Universitätsklinikum Hamburg-Eppendorf, Ann & Robert H Lurie Children's Hospital of Chicago, British Columbia Children's Hospital, Children's of Alabama, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, University of Oklahoma, Oregon Health and Science University, Rady Children's Hospital, San Diego, San Jorge Children's Hospital (Puerto Rico), University College Dublin, Tianjin Children's Hospital, University Hospital Schleswig-Holstein, University of California, San Francisco, University of Haifa, Uppsala University, Medical University of Lodz, Oslo University Hospital, Seattle Children's Hospital, Mayo Clinic
Conditions
(from sponsor)		 Legg Calve Perthes Disease
Related terms Bone Diseases, Femur Head Necrosis, Legg-Calve-Perthes Disease, Osteonecrosis
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov