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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2002 by National Center for Research Resources (NCRR). Recruitment status was Active, not recruiting

First Received on August 3, 2000. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	University of North Carolina
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00006130

Purpose

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	Intervention
Bone Avascular Necrosis Sickle Cell Anemia	Procedure: Core decompression

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Randomized Study of Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease

Resource links provided by NLM:

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: Anemia Osteonecrosis Sickle Cell Anemia

U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:	50
Study Start Date:	June 1999

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006130

Locations

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

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of North Carolina

Investigators

Study Chair:

Elliott P. Vichinsky

University of North Carolina

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00006130 History of Changes
Other Study ID Numbers:	NCRR-M01RR01271-5715, UNCCH-GCRC-1375
Study First Received:	August 3, 2000
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

arthritis & connective tissue diseases
avascular necrosis
disease-related problem/condition
genetic diseases and dysmorphic syndromes

hematologic disorders
pain
rare disease
sickle cell anemia

Additional relevant MeSH terms:

Anemia
Anemia, Sickle Cell
Necrosis
Osteonecrosis
Hematologic Diseases
Anemia, Hemolytic, Congenital

Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 12, 2012