Purpose

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 preference. Physicians pick an intervention for each age group and treat each patient with the same intervention.

Condition

Eligibility

Eligible Ages
Between 6 Years and 16 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 if not in the >11 age group

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Nonoperative management between ages 6-8 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 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 (stage I)
  • Procedure: osteotomy
    Surgical procedures that improve femoral head containment
    Other names:
    • Femoral osteotomy
    • Shelf osteotomy
Operative containment between age 6-8 in the late stages This arm examines operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) rendered in the later stage of the disease process (stage II)
  • Procedure: osteotomy
    Surgical procedures that improve femoral head containment
    Other names:
    • Femoral osteotomy
    • Shelf osteotomy
Nonoperative management between age 8-11 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 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.
  • Procedure: osteotomy
    Surgical procedures that improve femoral head containment
    Other names:
    • Femoral osteotomy
    • Shelf osteotomy
Operative containment with prolonged non-weightbearing 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.
  • Procedure: osteotomy
    Surgical procedures that improve femoral head containment
    Other names:
    • Femoral osteotomy
    • Shelf osteotomy
Multiple epiphyseal drilling for patients over age 11 Patients will receive Multiple drilling and be non weight bearing for 6 months according to the treating physician's preference
  • 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.
Multiple epiphyseal drilling and arthrodiastasis Patients will undergo multiple epiphyseal drilling with application of fixator for 3-4 months followed by 8-12 weeks of non-weight bearing after fixator removal.
  • 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.
Non-surgical management in over 11 age group Patients will be non-weight bearing and receive physical therapy according to the physician preferences.
Non-surgical 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).
Surgical 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).
  • Procedure: osteotomy
    Surgical procedures that improve femoral head containment
    Other names:
    • Femoral osteotomy
    • Shelf osteotomy
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).
  • Procedure: osteotomy
    Surgical procedures that improve femoral head containment
    Other names:
    • Femoral osteotomy
    • Shelf osteotomy

Recruiting Locations

Montefiore Greene Medical Arts Pavilion
New York, New York 10467
Contact:
Eric Fornari, MD
718-920-2060
efornari@montefiore.org

More Details

NCT ID
NCT02040714
Status
Recruiting
Sponsor
Texas Scottish Rite Hospital for Children

Study Contact

Harry K Kim, PhD
(214) 559-7620
harry.kim@tsrh.org

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. Those 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. Patient Reported Outcomes Measurement Information System (PROMIS) questionnaires will be completed via an online testing system, the NIH funded Assessment Center.

1-6 Cohort: For the 1-6 age patient group, patients presenting in an early stage of the disease (stage I or IIa), the surgeons who treat patients with one of the following 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).

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 2-4.

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, patients presenting in an early stage of the disease (stage I or IIa) we will collect prospective data from surgeons who are currently treating their patients with one of the following alternative treatment regimens 5,6:

1. Non-operative management (i.e. no osteotomy);

2. Core decompression or multiple epiphyseal drilling of the necrotic femoral head with post-operative non-weight bearing; or,

3. Core decompression or multiple epiphyseal drilling of the necrotic femoral head with application of hinged hip distractor.

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 from surgeons who are currently treating these patients with operative or non-operative treatment regimens.

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 de-identified radiographic and MR images, clinical information, and Perthes patient and/or outcomes questionnaire responses.

All patients willing to complete the PROMIS questionnaires will do so regardless of group, treatment, or stage of the disease. The administration of the instrument is facilitated by the use of an online testing platform, the NIH-funded Assessment Center. Data will be transmitted and stored on a secure and dedicated server for the purpose of this study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.