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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02040714
Ethics application status
Date submitted
2/01/2014
Date registered
20/01/2014
Date last updated
25/04/2019

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
Treatment: Surgery - multiple epiphyseal drilling

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)

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)

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.

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.

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

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.

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).

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
Surgical procedures that improve femoral head containment

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 - 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.
Timepoint [1] 0 0
5 years post intervention
Secondary outcome [1] 0 0
Perfusion percentage - 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.
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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with previous surgical treatment on the affected hip if not in the >11 age
group

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
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
Beijing
Country [26] 0 0
China
State/province [26] 0 0
Tianjin
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Lübeck
Country [29] 0 0
India
State/province [29] 0 0
Karnataka
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Seoul
Country [31] 0 0
Norway
State/province [31] 0 0
Oslo
Country [32] 0 0
Poland
State/province [32] 0 0
Lódz
Country [33] 0 0
Sweden
State/province [33] 0 0
Uppsala
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Liverpool
Country [35] 0 0
United Kingdom
State/province [35] 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 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
Mayo Clinic
Address [17] 0 0
Country [17] 0 0
Other collaborator category [18] 0 0
Other
Name [18] 0 0
Medical Universtity of Lodz
Address [18] 0 0
Country [18] 0 0
Other collaborator category [19] 0 0
Other
Name [19] 0 0
Montefiore Medical Center
Address [19] 0 0
Country [19] 0 0
Other collaborator category [20] 0 0
Other
Name [20] 0 0
Nationwide Children's Hospital
Address [20] 0 0
Country [20] 0 0
Other collaborator category [21] 0 0
Other
Name [21] 0 0
NYU Langone Health
Address [21] 0 0
Country [21] 0 0
Other collaborator category [22] 0 0
Other
Name [22] 0 0
OrthoCarolina Research Institute, Inc.
Address [22] 0 0
Country [22] 0 0
Other collaborator category [23] 0 0
Other
Name [23] 0 0
University of Sao Paulo General Hospital
Address [23] 0 0
Country [23] 0 0
Other collaborator category [24] 0 0
Other
Name [24] 0 0
Seoul National University Childrens Hospital
Address [24] 0 0
Country [24] 0 0
Other collaborator category [25] 0 0
Other
Name [25] 0 0
Shriners Hospitals for Children
Address [25] 0 0
Country [25] 0 0
Other collaborator category [26] 0 0
Other
Name [26] 0 0
University Hospital Southampton NHS Foundation Trust
Address [26] 0 0
Country [26] 0 0
Other collaborator category [27] 0 0
Other
Name [27] 0 0
Texas Children's Hospital
Address [27] 0 0
Country [27] 0 0
Other collaborator category [28] 0 0
Other
Name [28] 0 0
Phoenix Children's Hospital
Address [28] 0 0
Country [28] 0 0
Other collaborator category [29] 0 0
Other
Name [29] 0 0
University Hospital, Clermont-Ferrand
Address [29] 0 0
Country [29] 0 0
Other collaborator category [30] 0 0
Other
Name [30] 0 0
Universitätsklinikum Hamburg-Eppendorf
Address [30] 0 0
Country [30] 0 0
Other collaborator category [31] 0 0
Other
Name [31] 0 0
Sheffield Children's NHS Foundation Trust
Address [31] 0 0
Country [31] 0 0
Other collaborator category [32] 0 0
Other
Name [32] 0 0
Royal Children's Hospital
Address [32] 0 0
Country [32] 0 0

Ethics approval
Ethics application status

Summary
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 preference. Physicians pick
an intervention for each age group and treat each patient with the same intervention.
Trial website
https://clinicaltrials.gov/show/NCT02040714
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
Harry K Kim, PhD
Address 0 0
Country 0 0
Phone 0 0
(214) 559-7620
Fax 0 0
Email 0 0
harry.kim@tsrh.org
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02040714