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IPSG1
Sponsor study identifier
observational
1,500
15 countries
46
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
January 2, 2014
Actual (reported)January 20, 2014
Actual (reported)September 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Perfusion percentage
Just after diagnosis of Perthes disease
Stulberg classification
at 2 years and 5 years post intervention
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 containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) rendered in the early stage of the disease process
Patients who do not undergo some form of containment surgery because of medical, social, or other reasons will receive no surgical treatment.
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.
Surgical procedure that improves femoral head containment, plus a post-operative protocol that requires patient to maintain non-weight bearing for 6 months.
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.
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
Harry KW Kim, MD, MS
Texas Scottish Rite Hospital for Children
First Submitted
January 2, 2014
First Posted
January 20, 2014
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2032
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.
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.
Patients will be non-weight bearing and receive physical therapy according to the physician preferences.
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).
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).
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).
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).
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).
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 6, 2025
Record last verified: 2025-05
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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