Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease
IPSG1
1 other identifier
observational
1,500
15 countries
46
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2012
Longer than P75 for all trials
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 2, 2014
CompletedFirst Posted
Study publicly available on registry
January 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2032
May 6, 2025
May 1, 2025
20.1 years
January 2, 2014
May 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Perfusion percentage
Just after diagnosis of Perthes disease
Other Outcomes (1)
Stulberg classification
at 2 years and 5 years post intervention
Study Arms (12)
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).
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
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.
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.
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.
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.
Nonoperative management in over 11 age group
Patients will be non-weight bearing and receive physical therapy according to the physician preferences.
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).
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).
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).
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).
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).
Interventions
Surgical procedure that improves femoral head containment, plus a post-operative protocol that requires patient to maintain non-weight bearing for 6 months.
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.
Group will not undergo any surgical or invasive procedures during course of treatment.
Multiple epiphyseal drilling is a procedure that creates small holes in the femoral head growth plate to increase blood flow into the femoral head.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Patients with previous surgical treatment on the affected hip
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Texas Scottish Rite Hospital for Childrenlead
- Alberta Children's Hospitalcollaborator
- Alfred I. duPont Hospital for Childrencollaborator
- Le Bonheur Children's Hospitalcollaborator
- Children's Hospital Coloradocollaborator
- Children's Hospital Los Angelescollaborator
- Children's National Research Institutecollaborator
- Children's Healthcare of Atlantacollaborator
- Children's Hospital of Philadelphiacollaborator
- Children's Hospital Medical Center, Cincinnaticollaborator
- Columbia Universitycollaborator
- Connecticut Children's Medical Centercollaborator
- Gillette Children's Specialty Healthcarecollaborator
- Boston Children's Hospitalcollaborator
- Johns Hopkins Universitycollaborator
- Kaiser Permanentecollaborator
- Kasturba Medical Collegecollaborator
- Montefiore Medical Centercollaborator
- Nationwide Children's Hospitalcollaborator
- NYU Langone Healthcollaborator
- OrthoCarolina Research Institute, Inc.collaborator
- University of Sao Paulo General Hospitalcollaborator
- Seoul National University Childrens Hospitalcollaborator
- Shriners Hospitals for Childrencollaborator
- University Hospital Southampton NHS Foundation Trustcollaborator
- Baylor College of Medicinecollaborator
- Universitätsklinikum Hamburg-Eppendorfcollaborator
- Ann & Robert H Lurie Children's Hospital of Chicagocollaborator
- British Columbia Children's Hospitalcollaborator
- Children's of Alabamacollaborator
- Hospital Infantil Universitario Niño Jesús, Madrid, Spaincollaborator
- University of Oklahomacollaborator
- Oregon Health and Science Universitycollaborator
- Rady Children's Hospital, San Diegocollaborator
- San Jorge Children's Hospital (Puerto Rico)collaborator
- University College Dublincollaborator
- Tianjin Children's Hospitalcollaborator
- University Hospital Schleswig-Holsteincollaborator
- University of California, San Franciscocollaborator
- University of Haifacollaborator
- Uppsala Universitycollaborator
- Medical University of Lodzcollaborator
- Oslo University Hospitalcollaborator
- Seattle Children's Hospitalcollaborator
- Mayo Cliniccollaborator
Study Sites (46)
Children's Hospital of Alabama
Birmingham, Alabama, 35294, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Kaiser Permanente Hospital
Los Angeles, California, 90027, United States
Rady Children's Hospital California
San Diego, California, 92024, United States
UCSF Benioff Children's Hospitals
San Francisco, California, 94158, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Alfred I. DuPont Hospital for Children of the Nemours Foundation
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Children's Orthopaedics of Atlanta
Atlanta, Georgia, 30342, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Johns Hopkins
Baltimore, Maryland, 21218, United States
Children's Hospital Boston
Boston, Massachusetts, 02115-5724, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101, United States
NYU Langone/Hospital for Joint Disease
New York, New York, 10003, United States
New York Presbyterian Hospital (Columbia Campus)
New York, New York, 10032, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
OrthoCarolina
Charlotte, North Carolina, 28207, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Tennessee-Campbell Clinic
Germantown, Tennessee, 38138, United States
Texas Scottish Rite Hospital for Children
Dallas, Texas, 75219, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Women and Children's Hospital of Adelaide
Adelaide, South Australia, 5006, Australia
Universidade de São Paulo
São Paulo, 05508-070, Brazil
Alberta Children's Hospital, Division of Paediatric Surgery
Calgary, Alberta, T3B6A8, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
Tianjin Hospital Pediatric Orthopedics
Tianjin, 85016, China
Children's Hospital Hamburg-Altona
Hamburg, 22763, Germany
Hospital of Schleswig-Holstein
Lübeck, 23538, Germany
University Hospital of Schleswig-Holstein (Campus Lubeck)
Lübeck, Germany
Kasturba Medical College (KMC), Manipal
Udupi, Karnataka, India
Children's Health Ireland at Temple Street
Dublin, Ireland
Oslo University Hospital
Oslo, 0372, Norway
Medical University of Lodz
Lodz, Poland
San Jorge Children's Hospital
San Juan, 00912, Puerto Rico
Hospital Infantil Universitario Nino Jesus
Madrid, Spain
Uppsala University
Uppsala, Sweden
Centre hopsitalier universitaire Vaudois
Lausanne, Switzerland
Alder Hey Children's Hosopital (University of Oxford)
Liverpool, United Kingdom
Southampton Children's Hospital
Southampton, SO166YD, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Harry KW Kim, MD, MS
Texas Scottish Rite Hospital for Children
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Research
Study Record Dates
First Submitted
January 2, 2014
First Posted
January 20, 2014
Study Start
August 1, 2012
Primary Completion (Estimated)
September 1, 2032
Study Completion (Estimated)
September 1, 2032
Last Updated
May 6, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
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.