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

Legg Calve Perthes Disease Clinical Trial

— IPSG1  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02040714
• Other study ID #: IPSG 001
• Status: Enrolling by invitation
• Start date: August 2012
• Est. completion date: September 2032

Study information

• Verified date: May 2024
• Source: Texas Scottish Rite Hospital for Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1500
• Est. completion date: September 2032
• Est. primary completion date: September 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Legg Calve Perthes Disease

Intervention

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.
• 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 Observation
Group will not undergo any surgical or invasive procedures during course of treatment.
• 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.

Locations

Country	Name	City	State
Australia	Women and Children's Hospital of Adelaide	Adelaide	South Australia
Brazil	Universidade de São Paulo	São Paulo
Canada	Alberta Children's Hospital, Division of Paediatric Surgery	Calgary	Alberta
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
China	Tianjin Hospital Pediatric Orthopedics	Tianjin
Germany	Children's Hospital Hamburg-Altona	Hamburg
Germany	Hospital of Schleswig-Holstein	Lübeck
Germany	University Hospital of Schleswig-Holstein (Campus Lubeck)	Lübeck
India	Kasturba Medical College (KMC), Manipal	Udupi	Karnataka
Ireland	Children's Health Ireland at Temple Street	Dublin
Norway	Oslo University Hospital	Oslo
Poland	Medical University of Lodz	Lódz
Puerto Rico	San Jorge Children's Hospital	San Juan
Spain	Hospital Infantil Universitario Nino Jesus	Madrid
Sweden	Uppsala University	Uppsala
Switzerland	Centre hopsitalier universitaire Vaudois	Lausanne
United Kingdom	Alder Hey Children's Hosopital (University of Oxford)	Liverpool
United Kingdom	Southampton Children's Hospital	Southampton
United States	Children's Orthopaedics of Atlanta	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Johns Hopkins	Baltimore	Maryland
United States	Children's Hospital of Alabama	Birmingham	Alabama
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Children's Hospital at Montefiore	Bronx	New York
United States	OrthoCarolina	Charlotte	North Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Texas Scottish Rite Hospital for Children	Dallas	Texas
United States	University of Tennessee-Campbell Clinic	Germantown	Tennessee
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Texas Children's Hospital	Houston	Texas
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	Kaiser Permanente Hospital	Los Angeles	California
United States	New York Presbyterian Hospital (Columbia Campus)	New York	New York
United States	NYU Langone/Hospital for Joint Disease	New York	New York
United States	Oklahoma University Health Science Center	Oklahoma City	Oklahoma
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Gillette Children's Specialty Healthcare	Saint Paul	Minnesota
United States	Shriners Hospital for Children	Salt Lake City	Utah
United States	Rady Children's Hospital California	San Diego	California
United States	UCSF Benioff Children's Hospitals	San Francisco	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	Children's National Medical Center	Washington	District of Columbia
United States	Alfred I. DuPont Hospital for Children of the Nemours Foundation	Wilmington	Delaware

Sponsors (45)

Lead Sponsor

Collaborator

Texas Scottish Rite Hospital for Children

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

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  China,  Germany,  India,  Ireland,  Norway,  Poland,  Puerto Rico,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stulberg classification	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.	at 2 years and 5 years post intervention
Primary	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.	5 years post intervention
Secondary	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.	Just after diagnosis of Perthes disease

External Links

•   IPSG Website