MRI study of steroid-induced osteonecrosis

MRI study of steroid-induced osteonecrosis - MRI study of steroid-induced osteonecrosis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000001333

Enrollment

120

Registered

2008-08-22

Start date

2008-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

systemic lupus erythematosus and steroid-induced osteonecrosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) The patients fulfill the 1982 revised criteria for the classification of SLE of American College of Rheumatology (2)Asymptomatic joints at the initial examination (3) MRI screening for osteonecrosis of all hip and knee joints (4) Non-collapsed osteonecrosis at the initial MRI examination (5) Periodic MRI examinations of all hip and knee joints (6) Prospectively follow-up for at least 10 years (7) Imformed consent about this study (8) Outpatients

Exclusion criteria

Exclusion criteria: (1) Previous trauma and surgery (2) MRI can not undergo. (3) Unfavorable patient condition (4) Inappropriate patient

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactNAKAMURA JUNICHI

Chiba University Hospital Orthopaedic Surgery

shiken@office.chiba-u.jp

Outcome results