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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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

Detailed Summary:

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:

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.