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