Clinical trial NCT02040714: Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease
Official title: Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Legg Calve Perthes Disease
Keywords: femur head necrosis
hip
pediatric orthopedics
MRI
Osteonecrosis
Bone diseases
Legg Calve Perthes Syndrome
Lead sponsor: Texas Scottish Rite Hospital for Children
Sponsor class: OTHER
Collaborators: name: Alberta Children's Hospital
name: Alfred I. duPont Hospital for Children
name: Le Bonheur Children's Hospital
name: Children's Hospital Colorado
name: Children's Hospital Los Angeles
name: Children's National Research Institute
name: Children's Healthcare of Atlanta
name: Children's Hospital of Philadelphia
name: Children's Hospital Medical Center, Cincinnati
name: Columbia University
name: Connecticut Children's Medical Center
name: Gillette Children's Specialty Healthcare
name: Boston Children's Hospital
name: Johns Hopkins University
name: Kaiser Permanente
name: Kasturba Medical College
name: Montefiore Medical Center
name: Nationwide Children's Hospital
name: NYU Langone Health
name: OrthoCarolina Research Institute, Inc.
name: University of Sao Paulo General Hospital
name: Seoul National University Childrens Hospital
name: Shriners Hospitals for Children
name: University Hospital Southampton NHS Foundation Trust
name: Baylor College of Medicine
name: Universitätsklinikum Hamburg-Eppendorf
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: British Columbia Children's Hospital
name: Children's of Alabama
name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
name: University of Oklahoma
name: Oregon Health and Science University
name: Rady Children's Hospital, San Diego
name: San Jorge Children's Hospital (Puerto Rico)
name: University College Dublin
name: Tianjin Children's Hospital
name: University Hospital Schleswig-Holstein
name: University of California, San Francisco
name: University of Haifa
name: Uppsala University
name: Medical University of Lodz
name: Oslo University Hospital
name: Seattle Children's Hospital
name: Mayo Clinic
First posted: 2014-01-20
Enrollment: 1500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Sphericity deviation score of the femoral head
timeFrame: 5 years post intervention
Secondary outcomes:
measure: Perfusion percentage
timeFrame: Just after diagnosis of Perthes disease
Other outcomes:
measure: Stulberg classification
timeFrame: at 2 years and 5 years post intervention
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Hospital
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital California
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospitals
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Wilmington
country: United States
facility: Alfred I. DuPont Hospital for Children of the Nemours Foundation
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Children's Orthopaedics of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: Gillette Children's Specialty Healthcare
state: Minnesota
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
city: New York
country: United States
facility: NYU Langone/Hospital for Joint Disease
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital (Columbia Campus)
state: New York
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Health Science Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Germantown
country: United States
facility: University of Tennessee-Campbell Clinic
state: Tennessee
city: Dallas
country: United States
facility: Texas Scottish Rite Hospital for Children
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Adelaide
country: Australia
facility: Women and Children's Hospital of Adelaide
state: South Australia
city: São Paulo
country: Brazil
facility: Universidade de São Paulo
city: Calgary
country: Canada
facility: Alberta Children's Hospital, Division of Paediatric Surgery
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: Tianjin
country: China
facility: Tianjin Hospital Pediatric Orthopedics
city: Hamburg
country: Germany
facility: Children's Hospital Hamburg-Altona
city: Lübeck
country: Germany
facility: Hospital of Schleswig-Holstein
city: Lübeck
country: Germany
facility: University Hospital of Schleswig-Holstein (Campus Lubeck)
city: Udupi
country: India
facility: Kasturba Medical College (KMC), Manipal
state: Karnataka
city: Dublin
country: Ireland
facility: Children's Health Ireland at Temple Street
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Łódź
country: Poland
facility: Medical University of Lodz
city: San Juan
country: Puerto Rico
facility: San Jorge Children's Hospital
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus
city: Uppsala
country: Sweden
facility: Uppsala University
city: Lausanne
country: Switzerland
facility: Centre hopsitalier universitaire Vaudois
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hosopital (University of Oxford)
city: Southampton
country: United Kingdom
facility: Southampton Children's Hospital
Study officials:
affiliation: Texas Scottish Rite Hospital for Children
name: Harry KW Kim, MD, MS
role: STUDY_CHAIR
References: