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

NCT ID: NCT00006130

Last Updated: 2017-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-06-30

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.

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.

Conditions

Bone Avascular Necrosis; Sickle Cell Anemia

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

Core decompression

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role: lead

Principal Investigators

Elliott P. Vichinsky

Role: STUDY_CHAIR

UCSF Benioff Children's Hospital Oakland

Locations

Children's Hospital of Oakland

Oakland, California, United States

University of North Carolina School of Medicine

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

UNCCH-GCRC-1375

Identifier Type: -

Identifier Source: secondary_id

NCRR-M01RR01271-5715

Identifier Type: -

Identifier Source: org_study_id