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

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT00006130
First received: August 3, 2000
Last updated: February 14, 2017
Last verified: February 2017
  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:


Further study details as provided by Children's Hospital & Research Center Oakland:

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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Children's Hospital & Research Center Oakland
Investigators
Study Chair: Elliott P. Vichinsky Children's Hospital & Research Center Oakland
  More Information

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: February 14, 2017

Keywords provided by Children's Hospital & Research Center Oakland:
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, Sickle Cell
Necrosis
Osteonecrosis
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 18, 2017