Legg Calve Perthes DiseaseIPSG1NCT02040714
Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease
An observational study of Legg Calve Perthes Disease, run by Texas Scottish Rite Hospital for Children at 46 sites in 15 countries.
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… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Legg Calve Perthes Disease
- What is being tested?
- Osteotomy + Long Term Non-Weight Bearing, Osteotomy + Short Term Non-Weight Bearing and Nonoperative Observation
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 46 sitesin 15 countries
- Study dates
- Aug 2012to Sep 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with previous surgical treatment on the affected hip
Trial locations and contacts
46 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
46 sites in 15 countries
United States28 sites
Children's Orthopaedics of Atlanta
Atlanta, Georgia, 30342
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins
Baltimore, Maryland, 21218
Children's Hospital of Alabama
Birmingham, Alabama, 35294
Children's Hospital Boston
Boston, Massachusetts, 02115-5724
OrthoCarolina
Charlotte, North Carolina, 28207
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Texas Scottish Rite Hospital for Children
Dallas, Texas, 75219
University of Tennessee-Campbell Clinic
Germantown, Tennessee, 38138
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Kaiser Permanente Hospital
Los Angeles, California, 90027
NYU Langone/Hospital for Joint Disease
New York, New York, 10003
New York Presbyterian Hospital (Columbia Campus)
New York, New York, 10032
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, 73104
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101
Rady Children's Hospital California
San Diego, California, 92024
UCSF Benioff Children's Hospitals
San Francisco, California, 94158
Seattle Children's Hospital
Seattle, Washington, 98105
Children's Hospital at Montefiore
The Bronx, New York, 10467
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Alfred I. DuPont Hospital for Children of the Nemours Foundation
Wilmington, Delaware, 19803
Germany3 sites
Children's Hospital Hamburg-Altona
Hamburg, 22763
Hospital of Schleswig-Holstein
Lübeck, 23538
University Hospital of Schleswig-Holstein (Campus Lubeck)
Lübeck
Canada2 sites
Alberta Children's Hospital, Division of Paediatric Surgery
Calgary, Alberta, T3B6A8
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
United Kingdom2 sites
Alder Hey Children's Hosopital (University of Oxford)
Liverpool
Southampton Children's Hospital
Southampton, SO166YD
Australia1 site
Women and Children's Hospital of Adelaide
Adelaide, South Australia, 5006
About this study
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.
Read the 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 :
- Non-operative management (i.e., no osteotomy but can include soft tissue release);
- 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:
- Non-operative management (i.e., no osteotomy);
- Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) followed by 6 weeks of postoperative non-weight bearing; and,
- 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.
- Conditions
- Legg Calve Perthes Disease
- Being tested
- Osteotomy + Long Term Non-Weight Bearing, Osteotomy + Short Term Non-Weight Bearing, Nonoperative Observation, Multiple Epiphyseal Drilling
- Keywords
- femur head necrosis, hip, pediatric orthopedics, MRI, Osteonecrosis, Bone diseases, Legg Calve Perthes Syndrome
- Medical subject headings
- Legg-Calve-Perthes Disease, Femur Head Necrosis, Osteonecrosis, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteotomy + Long Term Non-Weight BearingProcedure or surgery
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 BearingProcedure or surgery
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 ObservationProcedure or surgery
Group will not undergo any surgical or invasive procedures during course of treatment.
Multiple Epiphyseal DrillingProcedure or surgery
Multiple epiphyseal drilling is a procedure that creates small holes in the femoral head growth plate to increase blood flow into the femoral head.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Nonoperative Observation | |
| 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 Receives: Procedure: Osteotomy + Long Term Non-Weight Bearing; Procedure: Osteotomy + Short Term Non-Weight Bearing | |
| 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. Receives: Procedure: Nonoperative Observation | |
| 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. Receives: Procedure: Osteotomy + Short Term Non-Weight Bearing | |
| 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. Receives: Procedure: Osteotomy + Long Term Non-Weight Bearing | |
| 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. Receives: Procedure: Osteotomy + Long Term Non-Weight Bearing; Procedure: Osteotomy + Short Term Non-Weight Bearing; Procedure: Multiple Epiphyseal Drilling | |
| Nonoperative management in over 11 age group | Patients will be non-weight bearing and receive physical therapy according to the physician preferences. Receives: Procedure: Nonoperative Observation | |
| 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). Receives: Procedure: Nonoperative Observation | |
| 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). Receives: Procedure: Osteotomy + Long Term Non-Weight Bearing; Procedure: Osteotomy + Short Term Non-Weight Bearing; Procedure: Multiple Epiphyseal Drilling | |
| 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). Receives: Procedure: Nonoperative Observation | |
| 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). Receives: Procedure: Nonoperative Observation | |
| 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). Receives: Procedure: Osteotomy + Long Term Non-Weight Bearing; Procedure: Osteotomy + Short Term Non-Weight Bearing; Procedure: Multiple Epiphyseal Drilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years post intervention
Secondary outcomes (1)
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.
Measured: Just after diagnosis of Perthes disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startAug 2012
- Primary completionSep 2032 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Legg Calve Perthes DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Scottish Rite Hospital for Children
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Children's Hospital, Alfred I. duPont Hospital for Children, Le Bonheur Children's Hospital, Children's Hospital Colorado, Children's Hospital Los Angeles, Children's National Research Institute, Children's Healthcare of Atlanta, Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, Columbia University, Connecticut Children's Medical Center, Gillette Children's Specialty Healthcare, Boston Children's Hospital, Johns Hopkins University, Kaiser Permanente, Kasturba Medical College, Montefiore Medical Center, Nationwide Children's Hospital, NYU Langone Health, OrthoCarolina Research Institute, Inc., University of Sao Paulo General Hospital, Seoul National University Childrens Hospital, Shriners Hospitals for Children, University Hospital Southampton NHS Foundation Trust, Baylor College of Medicine, Universitätsklinikum Hamburg-Eppendorf, Ann & Robert H Lurie Children's Hospital of Chicago, British Columbia Children's Hospital, Children's of Alabama, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, University of Oklahoma, Oregon Health and Science University, Rady Children's Hospital, San Diego, San Jorge Children's Hospital (Puerto Rico), University College Dublin, Tianjin Children's Hospital, University Hospital Schleswig-Holstein, University of California, San Francisco, University of Haifa, Uppsala University, Medical University of Lodz, Oslo University Hospital, Seattle Children's Hospital, Mayo Clinic
- Responsible party
- Principal investigator, Harry Kim, MD, Texas Scottish Rite Hospital for Children
- Investigators
- Harry KW Kim, MD, MS, Study chair, Texas Scottish Rite Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040714
- Sponsor's protocol ID
- IPSG 001
- Acronym
- IPSG1
- Status last verified
- May 2025
- First submitted
- 2 Jan 2014
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Patient enrolled in study will be deidentified (a specific ID will be assigned to participants) in each respective site, Each site will be in charge of entering their respective data in a main database. Data analysis of this collective data will be done mainly through the host site.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease
- ClinicalTrials.gov ID
- NCT02040714
- Acronym / sponsor ID
- IPSG1 / IPSG 001
- Conditions
- Legg Calve Perthes Disease
- Keywords
- femur head necrosis, hip, pediatric orthopedics, MRI, Osteonecrosis, Bone diseases, Legg Calve Perthes Syndrome
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Texas Scottish Rite Hospital for ChildrenUniversity, hospital or other
- Collaborators
- Alberta Children's Hospital, Alfred I. duPont Hospital for Children, Le Bonheur Children's Hospital, Children's Hospital Colorado, Children's Hospital Los Angeles, Children's National Research Institute, Children's Healthcare of Atlanta, Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, Columbia University, Connecticut Children's Medical Center, Gillette Children's Specialty Healthcare, Boston Children's Hospital, Johns Hopkins University, Kaiser Permanente, Kasturba Medical College, Montefiore Medical Center, Nationwide Children's Hospital, NYU Langone Health, OrthoCarolina Research Institute, Inc., University of Sao Paulo General Hospital, Seoul National University Childrens Hospital, Shriners Hospitals for Children, University Hospital Southampton NHS Foundation Trust, Baylor College of Medicine, Universitätsklinikum Hamburg-Eppendorf, Ann & Robert H Lurie Children's Hospital of Chicago, British Columbia Children's Hospital, Children's of Alabama, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, University of Oklahoma, Oregon Health and Science University, Rady Children's Hospital, San Diego, San Jorge Children's Hospital (Puerto Rico), University College Dublin, Tianjin Children's Hospital, University Hospital Schleswig-Holstein, University of California, San Francisco, University of Haifa, Uppsala University, Medical University of Lodz, Oslo University Hospital, Seattle Children's Hospital, Mayo Clinic
- Study start
- Aug 2012
- Primary completion
- Sep 2032 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- Non-operative management (i.e., no osteotomy but can include soft tissue release);
- 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:
- Non-operative management (i.e., no osteotomy);
- Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) followed by 6 weeks of postoperative non-weight bearing; and,
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Nonoperative management between ages 6-8 in early stage | – | Procedure: Nonoperative ObservationThe 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 | – | Procedure: Osteotomy + Long Term Non-Weight Bearing, Procedure: Osteotomy + Short Term Non-Weight BearingOperative 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 | – | Procedure: Nonoperative ObservationPatients 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 | – | Procedure: Osteotomy + Short Term Non-Weight BearingAs 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 | – | Procedure: Osteotomy + Long Term Non-Weight BearingAs 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 | – | Procedure: Osteotomy + Long Term Non-Weight Bearing, Procedure: Osteotomy + Short Term Non-Weight Bearing, Procedure: Multiple Epiphyseal DrillingPatients 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 | – | Procedure: Nonoperative ObservationPatients will be non-weight bearing and receive physical therapy according to the physician preferences. |
| Nonoperative management in 1-6 age group | – | Procedure: Nonoperative ObservationThe 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 | – | Procedure: Osteotomy + Long Term Non-Weight Bearing, Procedure: Osteotomy + Short Term Non-Weight Bearing, Procedure: Multiple Epiphyseal DrillingThe 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 | – | Procedure: Nonoperative ObservationPatients 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 | – | Procedure: Nonoperative ObservationPatients 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 | – | Procedure: Osteotomy + Long Term Non-Weight Bearing, Procedure: Osteotomy + Short Term Non-Weight Bearing, Procedure: Multiple Epiphyseal DrillingPatients 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). |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with previous surgical treatment on the affected hip
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteotomy + Long Term Non-Weight BearingSurgical procedure that improves femoral head containment, plus a post-operative protocol that requires patient to maintain non-weight bearing for 6 months. | Procedure or surgery | Late Stage Surgical Containment group, Operative containment for over 11 age group, Operative containment with prolonged non-weightbearing in early stage, Operative management between age 6-8 in early stage, Operative management in 1-6 age group |
| Osteotomy + Short Term Non-Weight BearingSurgical 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 or surgery | Late Stage Surgical Containment group, Operative containment for over 11 age group, Operative containment with short-term non-weightbearing in early stage, Operative management between age 6-8 in early stage, Operative management in 1-6 age group |
| Nonoperative ObservationGroup will not undergo any surgical or invasive procedures during course of treatment. | Procedure or surgery | Late Stage Bracing group, Late Stage Symptomatic treatment group, Nonoperative management between age 8-11 in early stage, Nonoperative management between ages 6-8 in early stage, Nonoperative management in 1-6 age group, Nonoperative management in over 11 age group |
| Multiple Epiphyseal DrillingMultiple epiphyseal drilling is a procedure that creates small holes in the femoral head growth plate to increase blood flow into the femoral head. | Procedure or surgery | Late Stage Surgical Containment group, Operative containment for over 11 age group, Operative management in 1-6 age group |
Primary outcome
Sphericity deviation score of the femoral head
Time frame: 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.
1 secondary outcome
Perfusion percentage
Time frame: Just after diagnosis of Perthes disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- IPSG WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Patient enrolled in study will be deidentified (a specific ID will be assigned to participants) in each respective site, Each site will be in charge of entering their respective data in a main database. Data analysis of this collective data will be done mainly through the host site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harry KW Kim, MD, MS study chair
Texas Scottish Rite Hospital for Children
46 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Legg Calve Perthes Disease, run by Texas Scottish Rite Hospital for Children at 46 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Germany, Canada, United Kingdom, Australia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sphericity deviation score of the femoral head (time frame: 5 years post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.