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

Sponsor

Texas Scottish Rite Hospital for Children (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT02040714

Collaborator

Alberta Children's Hospital (Other), Alfred I. duPont Hospital for Children (Other), Le Bonheur Children's Hospital (Other), Children's Hospital Colorado (Other), Children's Hospital Los Angeles (Other), Children's National Research Institute (Other), Children's Healthcare of Atlanta (Other), Children's Hospital of Philadelphia (Other), Children's Hospital Medical Center, Cincinnati (Other), Columbia University (Other), Connecticut Children's Medical Center (Other), Gillette Children's Specialty Healthcare (Other), Boston Children's Hospital (Other), Johns Hopkins University (Other), Kaiser Permanente (Other), Kasturba Medical College (Other), Montefiore Medical Center (Other), Nationwide Children's Hospital (Other), NYU Langone Health (Other), OrthoCarolina Research Institute, Inc. (Other), University of Sao Paulo General Hospital (Other), Seoul National University Childrens Hospital (Other), Shriners Hospitals for Children (Other), University Hospital Southampton NHS Foundation Trust (Other), Baylor College of Medicine (Other), Universitätsklinikum Hamburg-Eppendorf (Other), Ann & Robert H Lurie Children's Hospital of Chicago (Other), British Columbia Children's Hospital (Other), Children's of Alabama (Other), Hospital Infantil Universitario Niño Jesús, Madrid, Spain (Other), University of Oklahoma (Other), Oregon Health and Science University (Other), Rady Children's Hospital, San Diego (Other), San Jorge Children's Hospital (Puerto Rico) (Other), University College Dublin (Other), Tianjin Children's Hospital (Other), University Hospital Schleswig-Holstein (Other), University of California, San Francisco (Other), University of Haifa (Other), Uppsala University (Other)

1,500

Enrollment

Locations

241

Duration (Months)

35.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 :

Non-operative management (i.e., no osteotomy but can include soft tissue release);
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:

Non-operative management (i.e., no osteotomy);
Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) followed by 6 weeks of postoperative non-weight bearing; and,
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Aug 1, 2012

Anticipated Primary Completion Date :

Sep 1, 2032

Anticipated Study Completion Date :

Sep 1, 2032

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

Sphericity deviation score of the femoral head [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Alabama	Birmingham	Alabama	United States	35294
2	Children's Hospital of Los Angeles	Los Angeles	California	United States	90027
3	Kaiser Permanente Hospital	Los Angeles	California	United States	90027
4	Rady Children's Hospital California	San Diego	California	United States	92024
5	Children's Hospital Colorado	Aurora	Colorado	United States	80045
6	Connecticut Children's Medical Center	Hartford	Connecticut	United States	06106
7	Alfred I. DuPont Hospital for Children of the Nemours Foundation	Wilmington	Delaware	United States	19803
8	Children's National Medical Center	Washington	District of Columbia	United States	20010
9	Arnold Palmer Hospital for Children	Orlando	Florida	United States	32806
10	Paley Orthopedic & Spine Institute at St. Mary's Medical Center	West Palm Beach	Florida	United States	33407
11	Children's Orthopaedics of Atlanta	Atlanta	Georgia	United States	30342
12	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611
13	Johns Hopkins	Baltimore	Maryland	United States	21218
14	Children's Hospital Boston	Boston	Massachusetts	United States	02115-5724
15	Gillette Children's Specialty Healthcare	Saint Paul	Minnesota	United States	55101
16	Children's Hospital at Montefiore	Bronx	New York	United States	10467
17	NYU Langone/Hospital for Joint Disease	New York	New York	United States	10003
18	New York Presbyterian Hospital (Columbia Campus)	New York	New York	United States	10032
19	OrthoCarolina	Charlotte	North Carolina	United States	28207
20	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
21	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
22	Oregon Health and Science University	Portland	Oregon	United States	97239
23	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
24	University of Tennessee-Campbell Clinic	Germantown	Tennessee	United States	38138
25	Texas Scottish Rite Hospital for Children	Dallas	Texas	United States	75219
26	Texas Children's Hospital	Houston	Texas	United States	77030
27	Shriners Hospital for Children	Salt Lake City	Utah	United States	84103
28	Women and Children's Hospital of Adelaide	Adelaide	South Australia	Australia	5006
29	Universidade de São Paulo	São Paulo		Brazil	05508-070
30	Alberta Children's Hospital, Division of Paediatric Surgery	Calgary	Alberta	Canada	T3B6A8
31	British Columbia Children's Hospital	Vancouver	British Columbia	Canada	V6H 3V4
32	Tianjin Hospital Pediatric Orthopedics	Tianjin		China	85016
33	Children's Hospital Hamburg-Altona	Hamburg		Germany	22763
34	Hospital of Schleswig-Holstein	Lübeck		Germany	23538
35	University Hospital of Schleswig-Holstein (Campus Lubeck)	Lübeck		Germany
36	Kasturba Medical College (KMC), Manipal	Udupi	Karnataka	India
37	Seoul National University Children's Hospital	Seoul		Korea, Republic of	110-744
38	Oslo University Hospital	Oslo		Norway	0372
39	Medical University of Lodz	Łódź		Poland
40	Uppsala University	Uppsala		Sweden
41	Alder Hey Children's Hosopital (University of Oxford)	Liverpool		United Kingdom
42	Southampton Children's Hospital	Southampton		United Kingdom	SO166YD

Investigators

Study Chair: Harry KW Kim, MD, MS, Texas Scottish Rite Hospital for Children

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

IPSG Website

Publications

None provided.

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:

Jan 20, 2014

Last Update Posted:

Oct 25, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Harry Kim, MD, Director of Research, 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

Study Results

No Results Posted as of Oct 25, 2021

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

Study Details

Study Description

Brief Summary

Detailed Description

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Other Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Study Results