NCT00006130

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1999

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2000

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

First QC Date

August 3, 2000

Last Update Submit

February 14, 2017

Conditions

Bone Avascular NecrosisSickle Cell Anemia

Keywords

arthritis & connective tissue diseasesavascular necrosisdisease-related problem/conditiongenetic diseases and dysmorphic syndromeshematologic disorderspainrare diseasesickle cell anemia

Interventions

Core decompressionPROCEDURE

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non-sickle cell arthropathies
  • Concurrent chronic steroids
  • Chronic transfusion therapy
  • Alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Oakland

Oakland, California, 94609, United States

Location

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27599-7070, United States

Location

MeSH Terms

Conditions

OsteonecrosisAnemia, Sickle CellArthritisConnective Tissue DiseasesGenetic Diseases, InbornHematologic DiseasesPainRare Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHemic and Lymphatic DiseasesHemoglobinopathiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesJoint DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsDisease Attributes

Study Officials

  • Elliott P. Vichinsky

    UCSF Benioff Children's Hospital Oakland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2000

First Posted

August 4, 2000

Study Start

June 1, 1999

Last Updated

February 15, 2017

Record last verified: 2017-02

Locations

US(2)