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.

Condition	Treatment or Intervention
Bone Avascular Necrosis Sickle Cell Anemia	Procedure: Core decompression

Further Study Details: 

Expected Total Enrollment:  50

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.

Ages Eligible for Study:  10 Years and above,  Genders Eligible for Study:  Both

Criteria

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

California
      Children's Hospital of Oakland, Oakland,  California,  94609,  United States
North Carolina
      University of North Carolina School of Medicine, Chapel Hill,  North Carolina,  27599-7070,  United States

Study chairs or principal investigators

Elliott P. Vichinsky,  Study Chair,  University of North Carolina   

Study ID Numbers:  NCRR-M01RR01271-5715; UNCCH-GCRC-1375
Record last reviewed:  May 2002
Last Updated:  October 13, 2004
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006130
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08