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Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease Clinical research trials and Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease. Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease clinical trial. Human subjects often receive the most effective healthcare possible for their Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease  Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease
Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease
For Condition: Bone Avascular Necrosis,Sickle Cell Anemia
Status: No longer recruiting
Sponsor(s): National Center for Research Resources (NCRR) , University of North Carolina
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 10 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
ElliottVichinsky, Study Chair, University of North Carolina
Children's Hospital of Oakland
Oakland, California, 94609
United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599-7070
United States
Additional Information:
Study ID Numbers: NCRR-M01RR01271-5715; UNCCH-GCRC-1375
Study Start Date: June 1999
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006130
Other Sickle Cell Anemia Studies:
1. Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease
Related Studies:
Other Sickle Cell Anemia Clinical Trials
Other California Clinical Trials
Other Oakland Clinical Trials
Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease
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