Overview

This trial is active, not recruiting.

Conditions bone avascular necrosis, sickle cell anemia
Treatment core decompression
Sponsor National Center for Research Resources (NCRR)
Collaborator University of North Carolina
Start date June 1999
Trial size 50 participants
Trial identifier NCT00006130, NCRR-M01RR01271-5715, UNCCH-GCRC-1375

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 10 years old.

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

Additional Information

Official title Randomized Study of Decompression Coring Versus 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by National Center for Research Resources (NCRR).