The Study of Silicon Shoes Insert Benefits in Symptom and Radiology of Patients With Idiopathic Femoral Head Osteonecrosis: Two Arms Randomized Controlled Trial

C Femoral head osteonecrosis in one of the most common orthopedic diseases in which the exact etiology is unknown and has no specific treatment. This study was designed and with the theory of stopping the disease or at least showing down the progression of the disease and reducing the pain of patients with femoral head idiopathic osteonecrosis (ION).

This study was designed as a randomized clinical trial in which two control and interventional groups with a shoe insert were compared over a period of one year. The shoe insert was made of silicone gel and leather carbide with a thickness of one cm on the heel which gradually reduced until paw and was used at both feet. The study was considered to be meaningful with P<0.05.

A total of seven out of 14 patients were included in every group. They were followed up on a 4-time basis every 3 months and for 1 year. Harris Hip Score (HHS) and Ficat forms were completed for everyone. Despite the clinical satisfaction of the patients regarding the use of the shoe insert, HHS was not meaningful in their viewpoints. The progression of the disease was based on the Ficat form and according to P<0.003 although it was mildly meaningful and showed down the progression of femoral head ION in patients who used a shoe insert in the intervention group.

Although shoes insert clinically controlled pain in patients, it was not significant in data analysis. Finally, the use of shoe inserts could help slow down the progression of the ION femoral head.