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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02040714




Registration number
NCT02040714
Ethics application status
Date submitted
2/01/2014
Date registered
20/01/2014

Titles & IDs
Public title
Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease
Scientific title
Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease
Secondary ID [1] 0 0
IPSG 001
Universal Trial Number (UTN)
Trial acronym
IPSG1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Legg Calve Perthes Disease 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Osteotomy + Long Term Non-Weight Bearing
Treatment: Surgery - Osteotomy + Short Term Non-Weight Bearing
Treatment: Surgery - Nonoperative Observation
Treatment: Surgery - Multiple Epiphyseal Drilling

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).


Treatment: Surgery: 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.

Treatment: Surgery: 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.

Treatment: Surgery: Nonoperative Observation
Group will not undergo any surgical or invasive procedures during course of treatment.

Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sphericity deviation score of the femoral head
Timepoint [1] 0 0
5 years post intervention
Secondary outcome [1] 0 0
Perfusion percentage
Timepoint [1] 0 0
Just after diagnosis of Perthes disease

Eligibility
Key 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.
Minimum age
1 Year
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with previous surgical treatment on the affected hip

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2032
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Women and Children's Hospital of Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
5006 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Brazil
State/province [22] 0 0
São Paulo
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
China
State/province [25] 0 0
Tianjin
Country [26] 0 0
Germany
State/province [26] 0 0
Hamburg
Country [27] 0 0
Germany
State/province [27] 0 0
Lübeck
Country [28] 0 0
India
State/province [28] 0 0
Karnataka
Country [29] 0 0
Ireland
State/province [29] 0 0
Dublin
Country [30] 0 0
Norway
State/province [30] 0 0
Oslo
Country [31] 0 0
Poland
State/province [31] 0 0
Lódz
Country [32] 0 0
Puerto Rico
State/province [32] 0 0
San Juan
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Sweden
State/province [34] 0 0
Uppsala
Country [35] 0 0
Switzerland
State/province [35] 0 0
Lausanne
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Liverpool
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Other
Name
Texas Scottish Rite Hospital for Children
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Alberta Children's Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Alfred I. duPont Hospital for Children
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Le Bonheur Children's Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Children's Hospital Colorado
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Children's Hospital Los Angeles
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Children's National Research Institute
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Children's Healthcare of Atlanta
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Children's Hospital of Philadelphia
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Children's Hospital Medical Center, Cincinnati
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Columbia University
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Connecticut Children's Medical Center
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Gillette Children's Specialty Healthcare
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Boston Children's Hospital
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Johns Hopkins University
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
Kaiser Permanente
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
Kasturba Medical College
Address [16] 0 0
Country [16] 0 0
Other collaborator category [17] 0 0
Other
Name [17] 0 0
Montefiore Medical Center
Address [17] 0 0
Country [17] 0 0
Other collaborator category [18] 0 0
Other
Name [18] 0 0
Nationwide Children's Hospital
Address [18] 0 0
Country [18] 0 0
Other collaborator category [19] 0 0
Other
Name [19] 0 0
NYU Langone Health
Address [19] 0 0
Country [19] 0 0
Other collaborator category [20] 0 0
Other
Name [20] 0 0
OrthoCarolina Research Institute, Inc.
Address [20] 0 0
Country [20] 0 0
Other collaborator category [21] 0 0
Other
Name [21] 0 0
University of Sao Paulo General Hospital
Address [21] 0 0
Country [21] 0 0
Other collaborator category [22] 0 0
Other
Name [22] 0 0
Seoul National University Childrens Hospital
Address [22] 0 0
Country [22] 0 0
Other collaborator category [23] 0 0
Other
Name [23] 0 0
Shriners Hospitals for Children
Address [23] 0 0
Country [23] 0 0
Other collaborator category [24] 0 0
Other
Name [24] 0 0
University Hospital Southampton NHS Foundation Trust
Address [24] 0 0
Country [24] 0 0
Other collaborator category [25] 0 0
Other
Name [25] 0 0
Baylor College of Medicine
Address [25] 0 0
Country [25] 0 0
Other collaborator category [26] 0 0
Other
Name [26] 0 0
Universitätsklinikum Hamburg-Eppendorf
Address [26] 0 0
Country [26] 0 0
Other collaborator category [27] 0 0
Other
Name [27] 0 0
Ann & Robert H Lurie Children's Hospital of Chicago
Address [27] 0 0
Country [27] 0 0
Other collaborator category [28] 0 0
Other
Name [28] 0 0
British Columbia Children's Hospital
Address [28] 0 0
Country [28] 0 0
Other collaborator category [29] 0 0
Other
Name [29] 0 0
Children's of Alabama
Address [29] 0 0
Country [29] 0 0
Other collaborator category [30] 0 0
Other
Name [30] 0 0
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Address [30] 0 0
Country [30] 0 0
Other collaborator category [31] 0 0
Other
Name [31] 0 0
University of Oklahoma
Address [31] 0 0
Country [31] 0 0
Other collaborator category [32] 0 0
Other
Name [32] 0 0
Oregon Health and Science University
Address [32] 0 0
Country [32] 0 0
Other collaborator category [33] 0 0
Other
Name [33] 0 0
Rady Children's Hospital, San Diego
Address [33] 0 0
Country [33] 0 0
Other collaborator category [34] 0 0
Other
Name [34] 0 0
San Jorge Children's Hospital (Puerto Rico)
Address [34] 0 0
Country [34] 0 0
Other collaborator category [35] 0 0
Other
Name [35] 0 0
University College Dublin
Address [35] 0 0
Country [35] 0 0
Other collaborator category [36] 0 0
Other
Name [36] 0 0
Tianjin Children's Hospital
Address [36] 0 0
Country [36] 0 0
Other collaborator category [37] 0 0
Other
Name [37] 0 0
University Hospital Schleswig-Holstein
Address [37] 0 0
Country [37] 0 0
Other collaborator category [38] 0 0
Other
Name [38] 0 0
University of California, San Francisco
Address [38] 0 0
Country [38] 0 0
Other collaborator category [39] 0 0
Other
Name [39] 0 0
University of Haifa
Address [39] 0 0
Country [39] 0 0
Other collaborator category [40] 0 0
Other
Name [40] 0 0
Uppsala University
Address [40] 0 0
Country [40] 0 0
Other collaborator category [41] 0 0
Other
Name [41] 0 0
Medical University of Lodz
Address [41] 0 0
Country [41] 0 0
Other collaborator category [42] 0 0
Other
Name [42] 0 0
Oslo University Hospital
Address [42] 0 0
Country [42] 0 0
Other collaborator category [43] 0 0
Other
Name [43] 0 0
Seattle Children's Hospital
Address [43] 0 0
Country [43] 0 0
Other collaborator category [44] 0 0
Other
Name [44] 0 0
Mayo Clinic
Address [44] 0 0
Country [44] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Harry KW Kim, MD, MS
Address 0 0
Texas Scottish Rite Hospital for Children
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02040714