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

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

Approximately 40 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. PROMIS questionnaires will be completed via an online testing system, the NIH funded Assessment Center. For the 6—8 age patient group, 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. Nonoperative management (i.e., without osteotomy); 2. Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) rendered in the early stage of the disease process (stage I); or, 3. Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) rendered in the later stage of the disease process (stage II). For the 8—11 patient age group, the same treatment regimens will be studied: 1. Nonoperative management (i.e., without osteotomy); 2. Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) with 6 weeks post-operative non-weight bearing; and, 3. Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) with 6 months post-operative non-weight bearing. For the >11 patient age group, it is known the patients generally have poor prognosis and that the above treatments do not work well. Thus, we will collect prospective data from surgeons who are currently treating their patients with one of the following alternative treatment regimens 5,6: 1. Core decompression or multiple epiphyseal drilling of the necrotic femoral head; or, 2. Hip arthrodiastasis (application of hinged hip distractor) and core decompression/multiple epiphyseal drilling. 3. Non-operative management of symptoms with non-weight bearing Physicians participating in the study determine their preferred treatment arms for each age group and then enroll patients into arms according to the physicians declared treatment preference for the age group. Patient families have the option to elect nonoperative management even if it is the non-preferred treatment option of the physician. Information regarding patient characteristics at presentation, physical exam findings, responses to Perthes patient and/or outcomes questionnaires, and results of radiographic and MR imaging studies will be collected. 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.

Who is eligible to participate?

Inclusion Criteria: - Diagnosed with Legg-Calvé-Perthes disease - Between age 6-16 - 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

Last updated:

4/1/2014

NCT ID:

NCT02040714

IRB Number:

12-000263