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



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:6 - 16
Updated:2/14/2018
Start Date:August 2012
End Date:September 2032
Contact:Harry K Kim, PhD
Email:harry.kim@tsrh.org
Phone:(214) 559-7620

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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.

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.

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
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Charlotte, North Carolina 28207
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Chicago, Illinois 60614
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Dallas, Texas 75219
Principal Investigator: Harry Kim, MD
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6621 Fannin St
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