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Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease
This study is ongoing, but not recruiting participants.
Study NCT00006130   Information provided by National Center for Research Resources (NCRR)
First Received: August 3, 2000   Last Updated: June 23, 2005   History of Changes

August 3, 2000
June 23, 2005
June 1999
 
 
 
Complete list of historical versions of study NCT00006130 on ClinicalTrials.gov Archive Site
 
 
 
Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease
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.

 
Interventional
Treatment, Randomized
  • Bone Avascular Necrosis
  • Sickle Cell Anemia
Procedure: Core decompression
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
50
 
 

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
Both
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006130
 
NCRR-M01RR01271-5715, UNCCH-GCRC-1375
National Center for Research Resources (NCRR)
University of North Carolina
Study Chair: Elliott P. Vichinsky University of North Carolina
National Center for Research Resources (NCRR)
May 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP