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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01079455 |
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Date of registration:
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01/03/2010 |
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Primary sponsor: |
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Public title:
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Comparison of Hyaluronic Acid and Corticosteroid Intra-articular Injections for the Treatment of Osteoarthritis of the Hip
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Scientific title:
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Comparison of Hyaluronic Acid and Corticosteroid Intra-articular Injections for the Treatment of Osteoarthritis of the Hip Controlled With Intra-articular Injections With Bupivacaine |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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489 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01079455 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Sascha Colen, MD |
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Address:
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Telephone:
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0032497180798 |
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Email:
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sascolen@hotmail.com |
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Affiliation:
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Name:
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Sascha Colen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Pellenberg |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. an age between 30 and 70years
2. radiographic evidence of OA of the hip (Kellgren-Lawrence grading scale 1-3)
3. chronic pain for at least 3 months prior to study entry (day 0)
4. dissatisfaction with prior attempts at non-operative management including
nonsteroidal anti-inflammatory drugs.
Exclusion Criteria:
1. Kellgren and Lawrence grade 4
2. an intra-articular hip injection (with any corticosteroid, hyaluronic acid
preparation or other) within the previous three months
3. non compliance to the study procedures and or non completion of the study according
to investigator's judgment
4. rapid destructive hip.
5. a history of crystalline arthropathy or inflammatory arthritis, neuropathic
arthropathy
6. a current other problem in the affected extremity
7. contra-indications for the use of corticosteroids (gastrointestinal ulcer, severe
osteoporosis, psychiatric anamnesis, herpes simplex or zoster (viremic stadium),
varicella, 8 weeks before and 2 weeks after immunization, systemic mycosis,
poliomyelitic except of bulbar encephalitic form lymphadenitis after BCG-vaccination,
parenteral depot medication, closed- and wide-angle glaucoma)
8. allergy or hypersensitivity to any of the study medications or to contrast
solutions.
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coxarthrosis
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Intervention(s)
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Drug: Corticosterone
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Primary Outcome(s)
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Harris Hip Score
[Time Frame: 0 - 6 - 12 - 26 weeks]
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Secondary Outcome(s)
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Visual Analog Score
[Time Frame: 0 - 6 - 12 - 26 weeks]
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Secondary ID(s)
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2009-014274-17
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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