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| Tracking Information | |||||
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| First Received Date ICMJE | August 3, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | June 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00006130 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease | ||||
| Official Title ICMJE | Randomized Study of Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease | ||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized | ||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: Core decompression | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 10 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00006130 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NCRR-M01RR01271-5715, UNCCH-GCRC-1375 | ||||
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) | ||||
| Collaborators ICMJE | University of North Carolina | ||||
| Investigators ICMJE |
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| Information Provided By | National Center for Research Resources (NCRR) | ||||
| Verification Date | May 2002 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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