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

Sickle Cell Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006130
• Other study ID #: NCRR-M01RR01271-5715
• Secondary ID: UNCCH-GCRC-1375
• Status: Completed
• Phase: N/A
• First received: August 3, 2000
• Last updated: February 14, 2017
• Start date: June 1999

Study information

• Verified date: February 2017
• Source: Children's Hospital & Research Center Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Bone Avascular Necrosis
• Necrosis
• Osteonecrosis
• Sickle Cell Anemia

Intervention

Procedure:
• Core decompression

Locations

Country	Name	City	State
United States	University of North Carolina School of Medicine	Chapel Hill	North Carolina
United States	Children's Hospital of Oakland	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital & Research Center Oakland

Country where clinical trial is conducted

United States,