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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02040714
Recruitment Status : Enrolling by invitation
First Posted : January 20, 2014
Last Update Posted : October 25, 2021
Sponsor:
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 National 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
Montefiore Medical Center
Nationwide Children's Hospital
NYU Langone Health
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
Baylor College of Medicine
Universitätsklinikum Hamburg-Eppendorf
Ann & Robert H Lurie Children's Hospital of Chicago
British Columbia Children's Hospital
Children's of Alabama
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
University of Oklahoma
Oregon Health and Science University
Rady Children's Hospital, San Diego
San Jorge Children's Hospital (Puerto Rico)
University College Dublin
Tianjin Children's Hospital
University Hospital Schleswig-Holstein
University of California, San Francisco
University of Haifa
Uppsala University
Information provided by (Responsible Party):
Harry Kim, MD, Texas Scottish Rite Hospital for Children

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.


Condition or disease Intervention/treatment
Legg Calve Perthes Disease Procedure: Osteotomy + Long Term Non-Weight Bearing Procedure: Osteotomy + Short Term Non-Weight Bearing Procedure: Nonoperative Observation 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.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease
Study Start Date : August 2012
Estimated Primary Completion Date : September 2032
Estimated Study Completion Date : September 2032

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. 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.



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.


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
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

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


Locations
Show Show 42 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 National 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
Montefiore Medical Center
Nationwide Children's Hospital
NYU Langone Health
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
Baylor College of Medicine
Universitätsklinikum Hamburg-Eppendorf
Ann & Robert H Lurie Children's Hospital of Chicago
British Columbia Children's Hospital
Children's of Alabama
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
University of Oklahoma
Oregon Health and Science University
Rady Children's Hospital, San Diego
San Jorge Children's Hospital (Puerto Rico)
University College Dublin
Tianjin Children's Hospital
University Hospital Schleswig-Holstein
University of California, San Francisco
University of Haifa
Uppsala University
Investigators
Layout table for investigator information
Study Chair: Harry KW Kim, MD, MS Texas Scottish Rite Hospital for Children
Additional Information:
Layout table for additonal information
Responsible Party: Harry Kim, MD, Director of Research, Texas Scottish Rite Hospital for Children
ClinicalTrials.gov Identifier: NCT02040714    
Other Study ID Numbers: IPSG 001
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
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:
Layout table for MeSH terms
Legg-Calve-Perthes Disease
Bone Diseases
Musculoskeletal Diseases
Femur Head Necrosis
Osteonecrosis