Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease (IPSG1)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Legg Calve Perthes Disease
• Intervention / Treatment: Procedure: Nonoperative Observation; Procedure: Osteotomy + Long Term Non-Weight Bearing; Procedure: Osteotomy + Short Term Non-Weight Bearing; Procedure: Multiple Epiphyseal Drilling

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5006
      • Women and Children's Hospital of Adelaide
• Brazil
  • São Paulo, Brazil, 05508-070
    • Universidade de São Paulo
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B6A8
      • Alberta Children's Hospital, Division of Paediatric Surgery
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • British Columbia Children's Hospital
• China
  • Tianjin, China, 85016
    • Tianjin Hospital Pediatric Orthopedics
• Germany
  • Hamburg, Germany, 22763
    • Children's Hospital Hamburg-Altona
  • Lübeck, Germany, 23538
    • Hospital of Schleswig-Holstein
  • Lübeck, Germany
    • University Hospital of Schleswig-Holstein (Campus Lubeck)
• India
  • Karnataka
    • Udupi, Karnataka, India
      • Kasturba Medical College (KMC), Manipal
• Ireland
  • Dublin, Ireland
    • Children's Health Ireland at Temple Street
• Norway
  • Oslo, Norway, 0372
    • Oslo University Hospital
• Poland
  • Łódź, Poland
    • Medical University of Lodz
• Puerto Rico
  • San Juan, Puerto Rico, 00912
    • San Jorge Children's Hospital
• Spain
  • Madrid, Spain
    • Hospital Infantil Universitario Niño Jesús
• Sweden
  • Uppsala, Sweden
    • Uppsala University
• Switzerland
  • Lausanne, Switzerland
    • Centre hopsitalier universitaire Vaudois
• United Kingdom
  • Liverpool, United Kingdom
    • Alder Hey Children's Hosopital (University of Oxford)
  • Southampton, United Kingdom, SO166YD
    • Southampton Children's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Children's Hospital of Alabama
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital of Los Angeles
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Hospital
    • San Diego, California, United States, 92024
      • Rady Children's Hospital California
    • San Francisco, California, United States, 94158
      • UCSF Benioff Children's Hospitals
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Alfred I. DuPont Hospital for Children of the Nemours Foundation
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Children's Orthopaedics of Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02115-5724
      • Children's Hospital Boston
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
    • Saint Paul, Minnesota, United States, 55101
      • Gillette Children's Specialty Healthcare
  • New York
    • Bronx, New York, United States, 10467
      • Children's Hospital at Montefiore
    • New York, New York, United States, 10003
      • NYU Langone/Hospital for Joint Disease
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital (Columbia Campus)
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Health Science Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • University of Tennessee-Campbell Clinic
  • Texas
    • Dallas, Texas, United States, 75219
      • Texas Scottish Rite Hospital for Children
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with a recent diagnosis of Perthes disease that are being followed by a participating orthopedic surgeon. Participants are invited to participate during a visit to their treating hospital.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

12

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nonoperative management between ages 6-8 in early stage; The choice of non-osteotomy management without containment or surgical containment would be solely governed by the current practice of the participating surgeons (i.e. the current practice of the individual surgeon would be followed within the broad framework of the study).	Procedure: Nonoperative Observation; Group will not undergo any surgical or invasive procedures during course of treatment.
Operative management between age 6-8 in early stage; Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) rendered in the early stage of the disease process	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.
Nonoperative management between age 8-11 in early stage; Patients who do not undergo some form of containment surgery because of medical, social, or other reasons will receive no surgical treatment.	Procedure: Nonoperative Observation; Group will not undergo any surgical or invasive procedures during course of treatment.
Operative containment with short-term non-weightbearing in early stage; As per the current standard practice for patients between age 8-11 in developed countries, all patients will undergo some form of containment surgery (pelvic or femoral osteotomy) in order to better "contain" the femoral head underneath the acetabulum. Post-operative treatment will include 6 weeks of non-weight bearing on the operated leg.	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.
Operative containment with prolonged non-weightbearing in early stage; As per the current standard practice for patients between age 8-11, all patients will undergo some form of containment surgery (pelvic or femoral osteotomy) in order to better "contain" the femoral head underneath the acetabulum. Post-operative treatment will include 6 months of non-weight bearing on the operated leg.	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.
Operative containment for over 11 age group; Patients presenting over age 11 may receive multiple drilling and be non weight bearing for up to 6 months according to the treating physician's preference. Patients with application of fixator (arthrodiastasis) will be studied in this cohort arm as well, which typically involved 3-4 months followed by 8-12 weeks of non-weight bearing after fixator removal. Other surgical techniques may be included, however these are the most common for this age group.	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: 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.
Nonoperative management in over 11 age group; Patients will be non-weight bearing and receive physical therapy according to the physician preferences.	Procedure: Nonoperative Observation; Group will not undergo any surgical or invasive procedures during course of treatment.
Nonoperative management in 1-6 age group; The choice of non-osteotomy management without containment or surgical containment would be solely governed by the current practice of the participating surgeons (i.e. the current practice of the individual surgeon would be followed within the broad framework of the study).	Procedure: Nonoperative Observation; Group will not undergo any surgical or invasive procedures during course of treatment.
Operative management in 1-6 age group; The choice of osteotomy management with containment would be solely governed by the current practice of the participating surgeons (i.e. the current practice of the individual surgeon would be followed within the broad framework of the study).	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: 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.
Late Stage Bracing group; Patients presenting with <= 20 degrees of abduction on a maximum abduction x-ray treated with bracing who also present in the late stages of the disease (Waldenstrom Stage IIb or IIIa).The choice of management with or without containment or surgical containment would be solely governed by the current practice of the participating surgeons (i.e. the current practice of the individual surgeon would be followed within the broad framework of the study).	Procedure: Nonoperative Observation; Group will not undergo any surgical or invasive procedures during course of treatment.
Late Stage Symptomatic treatment group; Patients presenting in the late stages of the disease (defined as Waldenstrom stage IIb or IIIa) who are treated symptomatically. The choice of management with or without containment or surgical containment would be solely governed by the current practice of the participating surgeons (i.e. the current practice of the individual surgeon would be followed within the broad framework of the study).	Procedure: Nonoperative Observation; Group will not undergo any surgical or invasive procedures during course of treatment.
Late Stage Surgical Containment group; Patients presenting in the late stages of the disease (defined as Waldenstrom stage IIb or IIIa) who are treated with surgical containment. The choice of management with or without containment or surgical containment would be solely governed by the current practice of the participating surgeons (i.e. the current practice of the individual surgeon would be followed within the broad framework of the study).	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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sphericity deviation score of the femoral head	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.	5 years post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfusion percentage	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.	Just after diagnosis of Perthes disease

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stulberg classification	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.	at 2 years and 5 years post intervention

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• IPSG Website

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Estimated): September 1, 2032
• Study Completion (Estimated): September 1, 2032

Study Registration Dates

• First Submitted: January 2, 2014
• First Submitted That Met QC Criteria: January 15, 2014
• First Posted (Estimated): January 20, 2014

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: MRI; hip; Osteonecrosis; Bone diseases; femur head necrosis; pediatric orthopedics; Legg Calve Perthes Syndrome
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Femur Head Necrosis; Osteonecrosis; Legg-Calve-Perthes Disease
• Other Study ID Numbers: IPSG 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient enrolled in study will be deidentified (a specific ID will be assigned to participants) in each respective site, Each site will be in charge of entering their respective data in a main database. Data analysis of this collective data will be done mainly through the host site.