MRI study of steroid-induced osteonecrosis

UMIN ID: UMIN000001333

Registered date:22/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: systemic lupus erythematosus and steroid-induced osteonecrosis
• Date of first enrollment: 2008/08/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Changes of the necrotic area were evaluated as either improved, aggravated, or unchanged. Improvement was defined as either a reduction or disappearance of osteonecrosis, with reduction defined as an improvement of more than one type of the 2001 revised criteria for classification of osteonecrosis of the femoral head of the Japanese Ministry of Health, Labor and Welfare. Aggravation was defined as enlargement of a previous osteonecrotic lesion, a new lesion, and/or collapse of osteonecrosis. Enlargement included both cases that were enlarged after reduction of the necrotic area or were reduced after enlargement. Collapse was defined as MR finding of bone marrow edema with clinical symptom of pain. Collapse included cases subsequent to enlarged or new osteonecrotic lesions. Unchanged was defined as no change of the necrotic area. A p-value less than 0.05 is considered significant using Fisher exact probability test.
• Secondary Outcome: The total cumulative corticosteroid dose (g), mean corticosteroid dosage (mg/day), and duration of corticosteroid treatment (years) were compared between joints with and without osteonecrosis.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Previous trauma and surgery (2) MRI can not undergo. (3) Unfavorable patient condition (4) Inappropriate patient

Related Information

• Primary Sponsor: Department of Orthopaedic Surgery, Graduate school of Medicine, Chiba University
• Source(s) of Monetary Support: None