Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease
- Conditions
- Legg Calve Perthes Disease
- Interventions
- Procedure: Nonoperative ObservationProcedure: Osteotomy + Long Term Non-Weight BearingProcedure: Osteotomy + Short Term Non-Weight BearingProcedure: Multiple Epiphyseal Drilling
- Registration Number
- NCT02040714
- Lead Sponsor
- Texas Scottish Rite Hospital for Children
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1500
- 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.
- Patients with previous surgical treatment on the affected hip
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Operative management in 1-6 age group Osteotomy + Short Term Non-Weight Bearing 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 Symptomatic treatment group Nonoperative Observation 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). Operative management between age 6-8 in early stage Osteotomy + Long Term Non-Weight Bearing Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) rendered in the early stage of the disease process Operative management between age 6-8 in early stage Osteotomy + Short Term Non-Weight Bearing Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) rendered in the early stage of the disease process Operative management in 1-6 age group Osteotomy + Long Term Non-Weight Bearing 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 Nonoperative Observation 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). Nonoperative management between ages 6-8 in early stage Nonoperative Observation 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 for over 11 age group Multiple Epiphyseal Drilling 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. Late Stage Surgical Containment group Multiple Epiphyseal Drilling 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). Nonoperative management between age 8-11 in early stage Nonoperative Observation Patients who do not undergo some form of containment surgery because of medical, social, or other reasons will receive no surgical treatment. Operative containment for over 11 age group Osteotomy + Long Term Non-Weight Bearing 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. Operative containment for over 11 age group Osteotomy + Short Term Non-Weight Bearing 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 Nonoperative Observation Patients will be non-weight bearing and receive physical therapy according to the physician preferences. Late Stage Surgical Containment group Osteotomy + Short Term Non-Weight Bearing 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). Operative containment with short-term non-weightbearing in early stage Osteotomy + Short Term Non-Weight Bearing 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 Osteotomy + Long Term Non-Weight Bearing 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. Nonoperative management in 1-6 age group Nonoperative Observation 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 Multiple Epiphyseal Drilling 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 Surgical Containment group Osteotomy + Long Term Non-Weight Bearing 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).
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (46)
Hospital Infantil Universitario Nino Jesus
🇪🇸Madrid, Spain
Uppsala University
🇸🇪Uppsala, Sweden
Centre hopsitalier universitaire Vaudois
🇨🇭Lausanne, Switzerland
Kaiser Permanente Hospital
🇺🇸Los Angeles, California, United States
San Jorge Children's Hospital
🇵🇷San Juan, Puerto Rico
Alder Hey Children's Hosopital (University of Oxford)
🇬🇧Liverpool, United Kingdom
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States
Rady Children's Hospital California
🇺🇸San Diego, California, United States
UCSF Benioff Children's Hospitals
🇺🇸San Francisco, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Alfred I. DuPont Hospital for Children of the Nemours Foundation
🇺🇸Wilmington, Delaware, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Children's Orthopaedics of Atlanta
🇺🇸Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Gillette Children's Specialty Healthcare
🇺🇸Saint Paul, Minnesota, United States
Children's Hospital at Montefiore
🇺🇸Bronx, New York, United States
NYU Langone/Hospital for Joint Disease
🇺🇸New York, New York, United States
New York Presbyterian Hospital (Columbia Campus)
🇺🇸New York, New York, United States
OrthoCarolina
🇺🇸Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Oklahoma University Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Tennessee-Campbell Clinic
🇺🇸Germantown, Tennessee, United States
Texas Scottish Rite Hospital for Children
🇺🇸Dallas, Texas, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Women and Children's Hospital of Adelaide
🇦🇺Adelaide, South Australia, Australia
Universidade de São Paulo
🇧🇷São Paulo, Brazil
Alberta Children's Hospital, Division of Paediatric Surgery
🇨🇦Calgary, Alberta, Canada
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
Tianjin Hospital Pediatric Orthopedics
🇨🇳Tianjin, China
Children's Hospital Hamburg-Altona
🇩🇪Hamburg, Germany
Hospital of Schleswig-Holstein
🇩🇪Lübeck, Germany
University Hospital of Schleswig-Holstein (Campus Lubeck)
🇩🇪Lübeck, Germany
Kasturba Medical College (KMC), Manipal
🇮🇳Udupi, Karnataka, India
Children's Health Ireland at Temple Street
🇮🇪Dublin, Ireland
Oslo University Hospital
🇳🇴Oslo, Norway
Medical University of Lodz
🇵🇱Łódź, Poland
Southampton Children's Hospital
🇬🇧Southampton, United Kingdom