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

This study is currently recruiting participants.
Verified April 2017 by Harry Kim, MD, Texas Scottish Rite Hospital for Children
Sponsor:
ClinicalTrials.gov Identifier:
NCT02040714
First Posted: January 20, 2014
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Alberta Children's Hospital
Alfred I. duPont Hospital for Children
Le Bonheur Children's Hospital
Children's Hospital Colorado
Children's Hospital Los Angeles
Children's Research Institute
Children's Healthcare of Atlanta
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
Columbia University
Connecticut Children's Medical Center
Gillette Children's Specialty Healthcare
Boston Children’s Hospital
Johns Hopkins University
Kaiser Permanente
Kasturba Medical College
Mayo Clinic
Medical Universtity of Lodz
Montefiore Medical Center
Nationwide Children's Hospital
New York University Langone Medical Center
OrthoCarolina Research Institute, Inc.
University of Sao Paulo General Hospital
Seoul National University Childrens Hospital
Shriners Hospitals for Children
University Hospital Southampton NHS Foundation Trust
Texas Children's Hospital
Phoenix Children's Hospital
University Hospital, Clermont-Ferrand
Universitätsklinikum Hamburg-Eppendorf
Sheffield Children's NHS Foundation Trust
Royal Children's Hospital
Information provided by (Responsible Party):
Harry Kim, MD, Texas Scottish Rite Hospital for Children
  Purpose

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 preference. Physicians pick an intervention for each age group and treat each patient with the same intervention.


Condition Intervention
Legg Calve Perthes Disease Procedure: osteotomy Procedure: multiple epiphyseal drilling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease

Resource links provided by NLM:


Further study details as provided by Harry Kim, MD, Texas Scottish Rite Hospital for Children:

Primary Outcome Measures:
  • Sphericity deviation score of the femoral head [ Time Frame: 5 years post intervention ]
    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.


Secondary Outcome Measures:
  • Perfusion percentage [ Time Frame: Just after diagnosis of Perthes disease ]
    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.


Other Outcome Measures:
  • Stulberg classification [ Time Frame: at 2 years and 5 years post intervention ]
    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.


Estimated Enrollment: 1500
Study Start Date: August 2012
Estimated Study Completion Date: September 2032
Estimated Primary Completion Date: September 2032 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Nonoperative management between ages 6-8
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 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 (stage I)
Procedure: osteotomy
Surgical procedures that improve femoral head containment
Other Names:
  • Femoral osteotomy
  • Shelf osteotomy
Operative containment between age 6-8 in the late stages
This arm examines operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) rendered in the later stage of the disease process (stage II)
Procedure: osteotomy
Surgical procedures that improve femoral head containment
Other Names:
  • Femoral osteotomy
  • Shelf osteotomy
Nonoperative management between age 8-11
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
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
Surgical procedures that improve femoral head containment
Other Names:
  • Femoral osteotomy
  • Shelf osteotomy
Operative containment with prolonged non-weightbearing
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
Surgical procedures that improve femoral head containment
Other Names:
  • Femoral osteotomy
  • Shelf osteotomy
Multiple epiphyseal drilling for patients over age 11
Patients will receive Multiple drilling and be non weight bearing for 6 months according to the treating physician's preference
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.
Multiple epiphyseal drilling and arthrodiastasis
Patients will undergo multiple epiphyseal drilling with application of fixator for 3-4 months followed by 8-12 weeks of non-weight bearing after fixator removal.
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.
Non-surgical management in over 11 age group
Patients will be non-weight bearing and receive physical therapy according to the physician preferences.
Non-surgical 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).
Surgical 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
Surgical procedures that improve femoral head containment
Other Names:
  • Femoral osteotomy
  • Shelf osteotomy
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).
Procedure: osteotomy
Surgical procedures that improve femoral head containment
Other Names:
  • Femoral osteotomy
  • Shelf osteotomy

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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.
Criteria

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 if not in the >11 age group
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040714


Contacts
Contact: Harry K Kim, PhD (214) 559-7620 harry.kim@tsrh.org
Contact: Rebecca Nelson, BS (214) 559-5112 rebecca.nelson@tsrh.org

  Show 41 Study Locations
Sponsors and Collaborators
Texas Scottish Rite Hospital for Children
Alberta Children's Hospital
Alfred I. duPont Hospital for Children
Le Bonheur Children's Hospital
Children's Hospital Colorado
Children's Hospital Los Angeles
Children's Research Institute
Children's Healthcare of Atlanta
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
Columbia University
Connecticut Children's Medical Center
Gillette Children's Specialty Healthcare
Boston Children’s Hospital
Johns Hopkins University
Kaiser Permanente
Kasturba Medical College
Mayo Clinic
Medical Universtity of Lodz
Montefiore Medical Center
Nationwide Children's Hospital
New York University Langone Medical Center
OrthoCarolina Research Institute, Inc.
University of Sao Paulo General Hospital
Seoul National University Childrens Hospital
Shriners Hospitals for Children
University Hospital Southampton NHS Foundation Trust
Texas Children's Hospital
Phoenix Children's Hospital
University Hospital, Clermont-Ferrand
Universitätsklinikum Hamburg-Eppendorf
Sheffield Children's NHS Foundation Trust
Royal Children's Hospital
Investigators
Study Chair: Harry KW Kim, MD, MS Texas Scottish Rite Hospital for Children
  More Information

Additional Information:
Responsible Party: Harry Kim, MD, Director of Research, Texas Scottish Rite Hospital for Children
ClinicalTrials.gov Identifier: NCT02040714     History of Changes
Other Study ID Numbers: IPSG 001
First Submitted: January 2, 2014
First Posted: January 20, 2014
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Keywords provided by Harry Kim, MD, Texas Scottish Rite Hospital for Children:
femur head necrosis
hip
pediatric orthopedics
MRI
Osteonecrosis
Bone diseases
Legg Calve Perthes Syndrome

Additional relevant MeSH terms:
Legg-Calve-Perthes Disease
Femur Head Necrosis
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases


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