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



Status:Completed
Conditions:Orthopedic, Anemia
Therapuetic Areas:Hematology, Orthopedics / Podiatry
Healthy:No
Age Range:10 - Any
Updated:2/16/2017
Start Date:June 1999

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

OBJECTIVES: I. Phase II trial to determine surgical morbidity of decompression coring,
including any adverse events in the perioperative period and the rate of secondary medical
or surgical interventions.

II. Collect preliminary data to determine if decompression coring results in a substantial
improvement in pain and mobility compared to 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
We found this trial at
2
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Oakland, California 94609
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333 South Columbia Street
Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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