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

Status: Enrolling by invitation
Location: See all (42) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
United States
Alabama
Children's Hospital of Alabama
Birmingham
California
Children's Hospital of Los Angeles
Los Angeles
Kaiser Permanente Hospital
Los Angeles
Rady Children's Hospital California
San Diego
Colorado
Children's Hospital Colorado
Aurora
Connecticut
Connecticut Children's Medical Center
Hartford
Washington, D.c.
Children's National Medical Center
Washington
Delaware
Alfred I. DuPont Hospital for Children of the Nemours Foundation
Wilmington
Florida
Arnold Palmer Hospital for Children
Orlando
Paley Orthopedic & Spine Institute at St. Mary's Medical Center
West Palm Beach
Georgia
Children's Orthopaedics of Atlanta
Atlanta
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
Massachusetts
Children's Hospital Boston
Boston
Maryland
Johns Hopkins
Baltimore
Minnesota
Gillette Children's Specialty Healthcare
Saint Paul
North Carolina
OrthoCarolina
Charlotte
New York
Children's Hospital at Montefiore
Bronx
New York Presbyterian Hospital (Columbia Campus)
New York
NYU Langone/Hospital for Joint Disease
New York
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Nationwide Children's Hospital
Columbus
Oregon
Oregon Health and Science University
Portland
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
Tennessee
University of Tennessee-Campbell Clinic
Germantown
Texas
Texas Scottish Rite Hospital for Children
Dallas
Texas Children's Hospital
Houston
Utah
Shriners Hospital for Children
Salt Lake City
Other Locations
Australia
Women and Children's Hospital of Adelaide
Adelaide
Brazil
Universidade de São Paulo
São Paulo
Canada
Alberta Children's Hospital, Division of Paediatric Surgery
Calgary
British Columbia Children's Hospital
Vancouver
China
Tianjin Hospital Pediatric Orthopedics
Tianjin
Germany
Children's Hospital Hamburg-Altona
Hamburg
Hospital of Schleswig-Holstein
Lübeck
University Hospital of Schleswig-Holstein (Campus Lubeck)
Lübeck
India
Kasturba Medical College (KMC), Manipal
Udupi
Norway
Oslo University Hospital
Oslo
Poland
Medical University of Lodz
Łódź
Republic of Korea
Seoul National University Children's Hospital
Seoul
Sweden
Uppsala University
Uppsala
United Kingdom
Alder Hey Children's Hosopital (University of Oxford)
Liverpool
Southampton Children's Hospital
Southampton
Time Frame
Start Date: August 2012
Estimated Completion Date: September 2032
Participants
Target number of participants: 1500
Treatments
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).
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
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.
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.
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.
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.
Nonoperative management in over 11 age group
Patients will be non-weight bearing and receive physical therapy according to the physician preferences.
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).
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).
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).
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).
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).
Authors
Peter Kundy, Novais Eduardo, Benedikt Wilke, Jianping Zhang, Jennifer Laine, Harry Kim, Shawn Gilbert, Philip Mack, Eric Fornari, Paul Choi, Jeffrey Kessler, Kevin Klingele, Benjamin Shore, Vedant Kulkarni, Joshua Hyman, Wudbhav Sankar, Benjamin Martin, Mihir Thacker, Junichi Tamai, Judson Karlen, Eduardo Novais, Derek M Kelly, Scott Yang, David Godfried, Tim Schrader, Joseph Janicki, Stephen Sundberg, Klane White, Virginia Casey, John Tis, Charles Mehlman, Ludwig Meiss, Patricia Moreno, Tony Herring, Alex Aarvold, Jose Herrera, Courtney O'Donnell, Martin Russlies, Ralf Stuecker, Nicholas Clarke, Simon Thomas, Rachel Goldstein, Fábio Ferri-de-Barros, Roberto Guarniero, Yukun Wang, Stefan Huhnstock, Won Joon Yoo, David Feldman, Marek Synder, Noelle Larson, Salil Upasani, Marcel Abouassaly, Young-Jo Kim, Ola Wiig, Pablo Castaneda, Andrew Howard, Kishore Mulpuri, Hitesh Shah, WonJoon Yoo, Benjamin Joseph, Yasmin Hailer, Scott Rosenfeld
Sponsors
Collaborators: Children's Healthcare of Atlanta, Rady Children's Hospital, San Diego, Children's Hospital Colorado, University of Haifa, OrthoCarolina Research Institute, Inc., Universitätsklinikum Hamburg-Eppendorf, Uppsala University, Shriners Hospitals for Children, Columbia University, Children's Hospital Medical Center, Cincinnati, Tianjin Children's Hospital, Kaiser Permanente, University Hospital Southampton NHS Foundation Trust, Johns Hopkins University, Children's Hospital Los Angeles, University of Oklahoma, NYU Langone Health, British Columbia Children's Hospital, Connecticut Children's Medical Center, University of California, San Francisco, University Hospital Schleswig-Holstein, Boston Children's Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, Baylor College of Medicine, Oregon Health and Science University, Children's of Alabama, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Alfred I. duPont Hospital for Children, Montefiore Medical Center, Alberta Children's Hospital, University College Dublin, Children's Hospital of Philadelphia, Children's National Research Institute, Gillette Children's Specialty Healthcare, Le Bonheur Children's Hospital, Seoul National University Childrens Hospital, University of Sao Paulo General Hospital, Nationwide Children's Hospital, Kasturba Medical College, San Jorge Children's Hospital (Puerto Rico)
Leads: Texas Scottish Rite Hospital for Children

This content was sourced from clinicaltrials.gov

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