Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease
NCT ID: NCT02040714
Last Updated: 2025-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
1500 participants
OBSERVATIONAL
2012-08-31
2032-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Global Hip Dysplasia Registry
NCT04117685
Pediatric ACL: Understanding Treatment Options
NCT02772770
SCFE Longitudinal International Prospective Registry
NCT04117841
Evaluation of Aid to Diagnosis for Congenital Dysplasia of the Hip in General Practice
NCT04101903
Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH
NCT07166172
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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).
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).
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).
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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 Observation
Group will not undergo any surgical or invasive procedures during course of treatment.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
1 Year
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alberta Children's Hospital
OTHER
Alfred I. duPont Hospital for Children
OTHER
Le Bonheur Children's Hospital
OTHER
Children's Hospital Colorado
OTHER
Children's Hospital Los Angeles
OTHER
Children's National Research Institute
OTHER
Children's Healthcare of Atlanta
OTHER
Children's Hospital of Philadelphia
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Columbia University
OTHER
Connecticut Children's Medical Center
OTHER
Gillette Children's Specialty Healthcare
OTHER
Boston Children's Hospital
OTHER
Johns Hopkins University
OTHER
Kaiser Permanente
OTHER
Kasturba Medical College
OTHER
Montefiore Medical Center
OTHER
Nationwide Children's Hospital
OTHER
NYU Langone Health
OTHER
OrthoCarolina Research Institute, Inc.
OTHER
University of Sao Paulo General Hospital
OTHER
Seoul National University Childrens Hospital
OTHER
Shriners Hospitals for Children
OTHER
University Hospital Southampton NHS Foundation Trust
OTHER
Baylor College of Medicine
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
British Columbia Children's Hospital
OTHER
Children's of Alabama
OTHER
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
OTHER
University of Oklahoma
OTHER
Oregon Health and Science University
OTHER
Rady Children's Hospital, San Diego
OTHER
San Jorge Children's Hospital (Puerto Rico)
UNKNOWN
University College Dublin
OTHER
Tianjin Children's Hospital
OTHER
University Hospital Schleswig-Holstein
OTHER
University of California, San Francisco
OTHER
University of Haifa
OTHER
Uppsala University
OTHER
Medical University of Lodz
OTHER
Oslo University Hospital
OTHER
Seattle Children's Hospital
OTHER
Mayo Clinic
OTHER
Texas Scottish Rite Hospital for Children
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Harry Kim, MD
Director of Research
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Harry KW Kim, MD, MS
Role: STUDY_CHAIR
Texas Scottish Rite Hospital for Children
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital of Alabama
Birmingham, Alabama, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Kaiser Permanente Hospital
Los Angeles, California, United States
Rady Children's Hospital California
San Diego, California, United States
UCSF Benioff Children's Hospitals
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Alfred I. DuPont Hospital for Children of the Nemours Foundation
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Orthopaedics of Atlanta
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Johns Hopkins
Baltimore, Maryland, United States
Children's Hospital Boston
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States
NYU Langone/Hospital for Joint Disease
New York, New York, United States
New York Presbyterian Hospital (Columbia Campus)
New York, New York, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
OrthoCarolina
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Tennessee-Campbell Clinic
Germantown, Tennessee, United States
Texas Scottish Rite Hospital for Children
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Women and Children's Hospital of Adelaide
Adelaide, South Australia, Australia
Universidade de São Paulo
São Paulo, , Brazil
Alberta Children's Hospital, Division of Paediatric Surgery
Calgary, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Tianjin Hospital Pediatric Orthopedics
Tianjin, , China
Children's Hospital Hamburg-Altona
Hamburg, , Germany
Hospital of Schleswig-Holstein
Lübeck, , 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, , Norway
Medical University of Lodz
Lodz, , Poland
San Jorge Children's Hospital
San Juan, , 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, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
IPSG Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IPSG 001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.