Magnetic Resonance Imaging Follow-up on Temporomandibular Arthritis in Children With Juvenile Idiopathic Arthritis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University Hospital Tuebingen.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital Tuebingen
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00801593
First received: December 2, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | December 2, 2008 | ||||
| Last Updated Date | December 2, 2008 | ||||
| Start Date ICMJE | May 2008 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
TMJ arthritis on MRI [ Time Frame: every three to six months from recruitment to end of study ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Magnetic Resonance Imaging Follow-up on Temporomandibular Arthritis in Children With Juvenile Idiopathic Arthritis | ||||
| Official Title ICMJE | Arthritis of the Temporomandibular Joints in Children With Juvenile Idiopathic Arthritis- Pilot Study on Diagnostic Value of Ultrasonography and Magnetic Resonance Imaging and Influence of Drug Treatment | ||||
| Brief Summary | Children with juvenile idiopathic arthritis (JIA) suffer in up to 87% of the cases of arthritis of the temporomandibular joints (TMJs). Magnetic resonance imaging (MRI) is the only modality for the early diagnosis of TMJ involvement. Aim of the study is to compare symptoms and clinical findings with MRI and ultrasonography results and to describe the action of the current medication on the arthritis of the TMJs. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Children with JIA. |
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| Condition ICMJE | Juvenile Idiopathic Arthritis | ||||
| Intervention ICMJE | Procedure: Steroid injection into the TMJs.
In case of otherwise noncontrollable TMJ involvement steroids are injected into arthritic TMJs under MRI guidance. |
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| Study Group/Cohort (s) | Children with JIA
Intervention: Procedure: Steroid injection into the TMJs. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | June 2010 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00801593 | ||||
| Other Study ID Numbers ICMJE | TMJ PROSPECT2008 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Nikolay Tzaribachev, Dr., University Children's Hospital, Tuebingen | ||||
| Study Sponsor ICMJE | University Hospital Tuebingen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital Tuebingen | ||||
| Verification Date | December 2008 | ||||
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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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