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Enrolling by Invitation

NCT Number: NCT02040714

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

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.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Women and Children's Hospital of Adelaide, Adelaide, South Australia, Australia

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About this study

Approximately 50 pediatric orthopaedic surgeons from pediatric centers in the US and other countries have agreed to participate in this database as members of the International Perthes Study Group (IPSG). TSRH will be the lead center. Sites who agree to participate will seek IRB approval from their own institutions. Data will be collected prospectively and entered into REDCap (Research Electronic Data Capture), a browser-based research database.

1-6 Cohort: For the 1-6 age patient group, patients involved in any treatment will be asked to participate in the study.

6-8 Cohort: For the 6-8 age patient group, patients presenting in an early stage of the disease (stage I or IIa), the surgeons who treat their patients with one of the following three treatment regimens currently used in practice will be asked to participate in the study :

  • Non-operative management (i.e., no osteotomy but can include soft tissue release);
  • Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty).

8-11 Cohort: For the 8-11 patient age group, patients presenting in an early stage of the disease (stage I or IIa), the surgeons who treat their patients with one of the following treatment regiments currently used in practice will be asked to participate in the study:

  • Non-operative management (i.e., no osteotomy);
  • Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) followed by 6 weeks of postoperative non-weight bearing; and,
  • Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) followed by 6 months of postoperative non-weight bearing.

>11 Cohort Registry: For the >11 patient age group, we will collect prospective data from surgeons who are currently treating their patients with any treatment regimens.

Patients who present to an IPSG member or their group during the late stages of the disease (stage IIb or stage III) will also be arranged into four separate age cohorts, identical to the list above. We will collect prospective data for these cases, as well.

Regardless of the patient's stage at enrollment, the patient's age at diagnosis or assigned cohort, the following data will be collected: information regarding patient characteristics at presentation, physical exam findings, responses to Perthes patient and/or outcomes questionnaires, and results of radiographic and MR imaging.

Participants will be assigned a unique study number. A secure web application, REDCap, will be used to capture and store research information including radiographic and MR images, clinical information, and de-identified outcomes questionnaire responses. Data will be transmitted and stored on a secure and dedicated server for the purpose of this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with Legg-Calvé-Perthes disease
  • Between age 1-18
  • Patients with possible secondary femoral osteonecrosis if over the age of 11 due to trauma or corticosteroid therapy are also eligible.

Exclusion criteria

  • Patients with previous surgical treatment on the affected hip

Treatment and study plan

Osteotomy + Long Term Non-Weight Bearing

Procedure

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

Osteotomy + Short Term Non-Weight Bearing

Procedure

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.

Nonoperative Observation

Procedure

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

Multiple Epiphyseal Drilling

Procedure

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

Primary outcomes

  1. Sphericity deviation score of the femoral head

    Time frame: 5 years post intervention

    The primary outcome for each age group will be a quantitative estimate of the sphericity of the femoral head as a measure of femoral head deformity. A more deformed head will be less spherical. Greater deformity leads to an increased risk of arthritis early in life.

Secondary outcomes

  1. Perfusion percentage

    Time frame: Just after diagnosis of Perthes disease

    The perfusion percentage is a measure of the amount of blood flow in the femoral head relative to the volume of the whole head. This measure is calculated from the perfusion MRI images that are collected just prior to the application of the intervention.

Other outcomes

  1. Stulberg classification

    Time frame: at 2 years and 5 years post intervention

    The Stulberg classification is a categorical system used to describe the shape of the femoral head that is traditionally used to evaluate outcomes and arthritis risk for patients with Perthes disease.

Sponsors and collaborators

Lead sponsor

Texas Scottish Rite Hospital for Children

Other

Collaborators

  • Alberta Children's Hospital
  • Alfred I. duPont Hospital for Children
  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Baylor College of Medicine
  • Boston Children's Hospital
  • British Columbia Children's Hospital
  • Children's Healthcare of Atlanta
  • Children's Hospital Colorado
  • Children's Hospital Los Angeles
  • Children's Hospital Medical Center, Cincinnati
  • Children's Hospital of Philadelphia
  • Children's National Research Institute
  • Children's of Alabama
  • Columbia University
  • Connecticut Children's Medical Center
  • Gillette Children's Specialty Healthcare
  • Hospital Infantil Universitario Niño Jesús, Madrid, Spain
  • Johns Hopkins University
  • Kaiser Permanente
  • Kasturba Medical College
  • Le Bonheur Children's Hospital
  • Mayo Clinic
  • Medical University of Lodz
  • Montefiore Medical Center
  • NYU Langone Health
  • Nationwide Children's Hospital
  • Oregon Health and Science University
  • OrthoCarolina Research Institute, Inc.
  • Oslo University Hospital
  • Rady Children's Hospital, San Diego
  • San Jorge Children's Hospital (Puerto Rico)
  • Seattle Children's Hospital
  • Seoul National University Childrens Hospital
  • Shriners Hospitals for Children
  • Tianjin Children's Hospital
  • University College Dublin
  • University Hospital Schleswig-Holstein
  • University Hospital Southampton NHS Foundation Trust
  • University of California, San Francisco
  • University of Haifa
  • University of Oklahoma
  • University of Sao Paulo General Hospital
  • Universitätsklinikum Hamburg-Eppendorf
  • Uppsala University

Registry information

Acronym: IPSG1

Important dates

Study start
2012
Primary completion
2032
Study completion
2032
First posted
Jan 20, 2014
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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