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

NCT02040714 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2025-05-06

No results posted yet for this study

Summary

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.

Conditions

  • Legg Calve Perthes Disease

Interventions

PROCEDURE

Osteotomy + Long Term Non-Weight Bearing

Surgical procedure that improves femoral head containment, plus a post-operative protocol that requires patient to maintain non-weight bearing for 6 months.

PROCEDURE

Osteotomy + Short Term Non-Weight Bearing

Surgical procedure that improves femoral head containment, plus a post-operative protocol that allows early return to function after 6 weeks of non-weight bearing.

PROCEDURE

Nonoperative Observation

Group will not undergo any surgical or invasive procedures during course of treatment.

PROCEDURE

Multiple Epiphyseal Drilling

Multiple epiphyseal drilling is a procedure that creates small holes in the femoral head growth plate to increase blood flow into the femoral head.

Sponsors & Collaborators

  • Alberta Children's Hospital

    collaborator OTHER
  • Alfred I. duPont Hospital for Children

    collaborator OTHER
  • Le Bonheur Children's Hospital

    collaborator OTHER
  • Children's Hospital Colorado

    collaborator OTHER
  • Children's Hospital Los Angeles

    collaborator OTHER
  • Children's National Research Institute

    collaborator OTHER
  • Children's Healthcare of Atlanta

    collaborator OTHER
  • Children's Hospital of Philadelphia

    collaborator OTHER
  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER
  • Columbia University

    collaborator OTHER
  • Connecticut Children's Medical Center

    collaborator OTHER
  • Gillette Children's Specialty Healthcare

    collaborator OTHER
  • Boston Children's Hospital

    collaborator OTHER
  • Johns Hopkins University

    collaborator OTHER
  • Kaiser Permanente

    collaborator OTHER
  • Kasturba Medical College

    collaborator OTHER
  • Montefiore Medical Center

    collaborator OTHER
  • Nationwide Children's Hospital

    collaborator OTHER
  • NYU Langone Health

    collaborator OTHER
  • OrthoCarolina Research Institute, Inc.

    collaborator OTHER
  • University of Sao Paulo General Hospital

    collaborator OTHER
  • Seoul National University Childrens Hospital

    collaborator OTHER
  • Shriners Hospitals for Children

    collaborator OTHER
  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER
  • Baylor College of Medicine

    collaborator OTHER
  • Universitätsklinikum Hamburg-Eppendorf

    collaborator OTHER
  • Ann & Robert H Lurie Children's Hospital of Chicago

    collaborator OTHER
  • British Columbia Children's Hospital

    collaborator OTHER
  • Children's of Alabama

    collaborator OTHER
  • Hospital Infantil Universitario Niño Jesús, Madrid, Spain

    collaborator OTHER
  • University of Oklahoma

    collaborator OTHER
  • Oregon Health and Science University

    collaborator OTHER
  • Rady Children's Hospital, San Diego

    collaborator OTHER
  • San Jorge Children's Hospital (Puerto Rico)

    collaborator UNKNOWN
  • University College Dublin

    collaborator OTHER
  • Tianjin Children's Hospital

    collaborator OTHER
  • University Hospital Schleswig-Holstein

    collaborator OTHER
  • University of California, San Francisco

    collaborator OTHER
  • University of Haifa

    collaborator OTHER
  • Uppsala University

    collaborator OTHER
  • Medical University of Lodz

    collaborator OTHER
  • Oslo University Hospital

    collaborator OTHER
  • Seattle Children's Hospital

    collaborator OTHER
  • Mayo Clinic

    collaborator OTHER
  • Texas Scottish Rite Hospital for Children

    lead OTHER

Principal Investigators

  • Harry KW Kim, MD, MS · Texas Scottish Rite Hospital for Children

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2032-09-30
Completion
2032-09-30

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • China
  • Germany
  • India
  • Ireland
  • Norway
  • Poland
  • Puerto Rico
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02040714 on ClinicalTrials.gov