Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Osteotomy + Long Term Non-Weight Bearing, Osteotomy + Short Term Non-Weight Bearing, Nonoperative Observation, Multiple Epiphyseal Drilling.
- Who it may be relevant to
- Registry conditions: Legg Calve Perthes Disease. Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Brazil, Canada, China +10
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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 Nonoperative Observation
Group will not undergo any surgical or invasive procedures during course of treatment. - 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.
Primary outcome measures
- Sphericity deviation score of the femoral head [Time frame: 5 years post intervention]
Secondary outcome measures (1)
- Perfusion percentage [Time frame: Just after diagnosis of Perthes disease]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 28 centers
- Children's Hospital of Alabama — Birmingham
- Children's Hospital of Los Angeles — Los Angeles
- Kaiser Permanente Hospital — Los Angeles
- Rady Children's Hospital California — San Diego
- UCSF Benioff Children's Hospitals — San Francisco
- Children's Hospital Colorado — Aurora
- Connecticut Children's Medical Center — Hartford
- Alfred I. DuPont Hospital for Children of the Nemours Foundation — Wilmington
- … and 20 more centers
Germany · 3 centers
- Children's Hospital Hamburg-Altona — Hamburg
- Hospital of Schleswig-Holstein — Lübeck
- University Hospital of Schleswig-Holstein (Campus Lubeck) — Lübeck
Canada · 2 centers
- Alberta Children's Hospital, Division of Paediatric Surgery — Calgary
- British Columbia Children's Hospital — Vancouver
United Kingdom · 2 centers
- Alder Hey Children's Hosopital (University of Oxford) — Liverpool
- Southampton Children's Hospital — Southampton
Australia · 1 center
- Women and Children's Hospital of Adelaide — Adelaide
Brazil · 1 center
- Universidade de São Paulo — São Paulo
China · 1 center
- Tianjin Hospital Pediatric Orthopedics — Tianjin
India · 1 center
- Kasturba Medical College (KMC), Manipal — Udupi
Ireland · 1 center
- Children's Health Ireland at Temple Street — Dublin
Norway · 1 center
- Oslo University Hospital — Oslo
Poland · 1 center
- Medical University of Lodz — Lodz
Puerto Rico · 1 center
- San Jorge Children's Hospital — San Juan
Spain · 1 center
- Hospital Infantil Universitario Nino Jesus — Madrid
Sweden · 1 center
- Uppsala University — Uppsala
Switzerland · 1 center
- Centre hopsitalier universitaire Vaudois — Lausanne
Identifiers
NCT: NCT02040714 · IPSG 001