Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of avascular necrosis (I vs II vs III). Patients are randomized into one of two treatment arms.

Arm I: Patients undergo a core biopsy and decompression of the hip followed by a standardized program of touch down or nonweight bearing with appropriate equipment and regular physical therapy for 6 weeks and then full weight bearing if tolerated.

Arm II: Patients undergo the standardized ambulation and physical therapy program as in arm I. They do not undergo any surgical procedure.

For 1 week prior to the beginning of the standardized program and during the 6 weeks of touch down or nonweight bearing, all patients complete a weekly pain and medication diary.

Patients are followed at 3 months and 6 months, then every 6 months for 1.5 years, and then annually for up to 5 years.

Inclusion criteria

• Diagnosis of stage I, II, or III avascular necrosis (AVN) by MRI or plain film imaging that is related to sickle cell disease
• Clinically moderate to severe pain originating from the hip and/or limitation of movement of the affected hip
• AVN in the contralateral hip allowed, regardless of stage, if the primary hip is eligible If both hips eligible, most symptomatic hip enrolled

Exclusion criteria

• Non-sickle cell arthropathies
• Concurrent chronic steroids
• Chronic transfusion therapy
• Alcoholism