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

Last updated: May 2, 2025
Sponsor: Texas Scottish Rite Hospital for Children
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

Multiple Epiphyseal Drilling

Osteotomy + Long Term Non-Weight Bearing

Nonoperative Observation

Clinical Study ID

NCT02040714
IPSG 001
  • Ages 1-18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 totrauma or corticosteroid therapy are also eligible.

Exclusion

Exclusion Criteria:

  • Patients with previous surgical treatment on the affected hip

Study Design

Total Participants: 1500
Treatment Group(s): 4
Primary Treatment: Multiple Epiphyseal Drilling
Phase:
Study Start date:
August 01, 2012
Estimated Completion Date:
September 30, 2032

Study Description

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 :

  1. Non-operative management (i.e., no osteotomy but can include soft tissue release);

  2. 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:

  1. Non-operative management (i.e., no osteotomy);

  2. Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) followed by 6 weeks of postoperative non-weight bearing; and,

  3. 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.

Connect with a study center

  • Women and Children's Hospital of Adelaide

    Adelaide, South Australia 5006
    Australia

    Site Not Available

  • Universidade de São Paulo

    São Paulo, 05508-070
    Brazil

    Site Not Available

  • Alberta Children's Hospital, Division of Paediatric Surgery

    Calgary, Alberta T3B6A8
    Canada

    Site Not Available

  • British Columbia Children's Hospital

    Vancouver, British Columbia V6H 3V4
    Canada

    Site Not Available

  • IWK Health Centre

    Halifax, Nova Scotia B3K 6R8
    Canada

    Site Not Available

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Beijing University

    Beijing, 100871
    China

    Site Not Available

  • Tianjin Hospital Pediatric Orthopedics

    Tianjin, 85016
    China

    Site Not Available

  • Children's Hospital Hamburg-Altona

    Hamburg, 22763
    Germany

    Site Not Available

  • Hospital of Schleswig-Holstein

    Lübeck, 23538
    Germany

    Site Not Available

  • University Hospital of Schleswig-Holstein (Campus Lubeck)

    Lübeck,
    Germany

    Site Not Available

  • Kinderzentrum Mecklenburg

    Schwerin, 22609
    Germany

    Site Not Available

  • Kasturba Medical College (KMC), Manipal

    Manipal, Karnataka
    India

    Site Not Available

  • Kasturba Medical College (KMC), Manipal

    Udupi, Karnataka
    India

    Site Not Available

  • Children's Health Ireland at Temple Street

    Dublin,
    Ireland

    Site Not Available

  • Seoul National University Children's Hospital

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • Shriners Hospital for Children

    Mexico City, Mexico, DF 04600
    Mexico

    Site Not Available

  • Oslo University Hospital

    Oslo, 0372
    Norway

    Site Not Available

  • Medical University of Lodz, Poland

    Lodz,
    Poland

    Site Not Available

  • Medical University of Lodz

    Łódź,
    Poland

    Site Not Available

  • San Jorge Children's Hospital

    San Juan, 00912
    Puerto Rico

    Site Not Available

  • Hospital Infantil Universitario Nino Jesus

    Madrid,
    Spain

    Site Not Available

  • Uppsala University

    Uppsala,
    Sweden

    Site Not Available

  • Centre hopsitalier universitaire Vaudois

    Lausanne,
    Switzerland

    Site Not Available

  • Bristol Royal Hospital for Children

    Bristol, Avon BS2 8BJ
    United Kingdom

    Site Not Available

  • Sanjeev Madan

    Sheffield, South Yorkshire
    United Kingdom

    Site Not Available

  • Alder Hey Children's Hosopital (University of Oxford)

    Liverpool,
    United Kingdom

    Site Not Available

  • Southampton Children's Hospital

    Southampton, SO166YD
    United Kingdom

    Site Not Available

  • Children's Hospital of Alabama

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Arizona College of Medicine

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Children's Hospital of Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Kaiser Permanente Hospital

    Los Angeles, California 90027
    United States

    Site Not Available

  • Rady Children's Hospital California

    San Diego, California 92024
    United States

    Site Not Available

  • UCSF Benioff Children's Hospitals

    San Francisco, California 94158
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Alfred I. DuPont Hospital for Children of the Nemours Foundation

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, D.C., District of Columbia 20010
    United States

    Site Not Available

  • Arnold Palmer Hospital for Children

    Orlando, Florida 32806
    United States

    Site Not Available

  • Paley Orthopedic & Spine Institute at St. Mary's Medical Center

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Children's Orthopaedics of Atlanta

    Atlanta, Georgia 30342
    United States

    Site Not Available

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

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Johns Hopkins

    Baltimore, Maryland 21218
    United States

    Site Not Available

  • Children's Hospital Boston

    Boston, Massachusetts 02115-5724
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Gillette Children's Specialty Healthcare

    Saint Paul, Minnesota 55101
    United States

    Site Not Available

  • Gillette Children's Specialty Healthcare

    St. Paul, Minnesota 55101
    United States

    Site Not Available

  • Children's Hospital at Montefiore

    Bronx, New York 10467
    United States

    Site Not Available

  • NYU Langone/Hospital for Joint Disease

    New York, New York 10003
    United States

    Site Not Available

  • New York Presbyterian Hospital (Columbia Campus)

    New York, New York 10032
    United States

    Site Not Available

  • Montefiore Greene Medical Arts Pavilion

    New York City, New York 10467
    United States

    Site Not Available

  • OrthoCarolina

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Oklahoma University Health Science Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Tennessee-Campbell Clinic

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Texas Scottish Rite Hospital for Children

    Dallas, Texas 75219
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Shriners Hospital for Children

    Salt Lake City, Utah 84103
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

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