Which is the Most Reliable Radiologic Examination for the Diagnosis of Rotator Cuff Tendon Tear? (COIFFE)
| Tracking Information | |||||
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| First Received Date ICMJE | June 19, 2009 | ||||
| Last Updated Date | July 28, 2009 | ||||
| Start Date ICMJE | September 2003 | ||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To determine which of the 3 radiological examinations, MRI, MR-arthrography and CT-arthrography, is the best in term of sensitivity, specificity and predictive value, in the preoperative assessment of rotator cuff tears. [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00925366 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To improve our knowledge of the radiological aspect of degenerative lesions of rotator cuff tendon thanks to clinical, radiological and surgical confrontations [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| 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 | Which is the Most Reliable Radiologic Examination for the Diagnosis of Rotator Cuff Tendon Tear? | ||||
| Official Title ICMJE | Comparative Performances of CT-arthrography, MRI and MR-arthrography in the Preoperative Assessment of the Rotator Cuff Tendon Tears, Surgical Observations Being Used as a Standard. | ||||
| Brief Summary | At this point in time the approach to the diagnosis of rotator cuff tendon tears is not consensual. The French surgeons, considering they have a good experience of this method, preferably use a shoulder CT-arthrography. Whereas in the United States surgeons rather rely on MRI or MR-arthrography of the shoulder. However, nobody can say which of these three examinations is most precise and gives the best information. We proposed to carry out the three examinations at the same time in a large number of patients who needed to be operated for a rotator cuff tendon tear and then to compare the results of each of these examinations with the operative observations. |
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| Detailed Description | Rotator cuff tendon tear is the principal pathology of the shoulder. These degenerative tendon lesions are due to normal ageing. True complete asymptomatic tears are even quite frequently noted in old subjects. However, they can be very invalidating. The majority of these degenerative lesions are treated medically. In a limited number of cases, a surgical treatment aimed at reducing a mechanical conflict and/or repair the tendons is necessary. The indication for a surgical treatment is based on the clinical evaluation and the radiological assessment. The radiological assessment is essential to confirm the tears but also to evaluate their extent. The type of surgery depends on this anatomic and radiologic assessment. It is thus possible, in the event of small complete tear, to make a simple tendon suture or a transosseous reinsertion. On the other hand, in the event of a large tear with tendon retraction, muscular flap reconstruction is needed. The preoperative radiological assessment is based on different radiological examinations, exploring the tendons. In the United States, MRI is mainly used in this case. In France, it is CT-arthrography which is regarded as the standard of care because the high contrast resolution of the images obtained and their reliability appear to be higher than those of MRI. The articular puncture necessary to perform this examination is not regarded in our country as an obstacle. The MR-arthrography, which consists in injecting into the joint of very low concentration of gadolinium, makes it possible to obtain an arthrographic effect in MRI. This examination gives images with an excellent contrast. It is already very widespread in the USA. In France, we have an increasingly large experience of it, but still limited. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Imaging Procedure
CT Arthroscopy of the Shoulder - MR Arthroscopy of the Shoulder - MR of the shoulder |
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| Study Arm (s) | Shoulder rotator cuff tear
Shoulder rotator cuff tear
Intervention: Other: Imaging Procedure |
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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 | Completed | ||||
| Enrollment ICMJE | 64 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00925366 | ||||
| Other Study ID Numbers ICMJE | P020909 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Myriem CARRIER, Department of Clinical Research of Developpement | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | June 2009 | ||||
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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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