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

Condition(s) studied

Investigational drug(s) / intervention(s)

Osteotomy + Long Term Non-Weight Bearing: 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 Bearing: 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 Observation: Group will not undergo any surgical or invasive procedures during course of treatment.

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.

Study 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 treatment expertise, and is not pre-determined by the study.

Eligibility

Primary outcome measure(s)

• Sphericity deviation score of the femoral head — 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.

Trial sites (46)

+ 6 more sites — see the full list on the official registry below.