Which is the Most Reliable Radiologic Examination for the Diagnosis of Rotator Cuff Tendon Tear? (COIFFE)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||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.|
- 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 ]
- 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 ]
|Study Start Date:||September 2003|
|Study Completion Date:||June 2009|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Shoulder rotator cuff tear
Shoulder rotator cuff tear
Other: Imaging Procedure
CT Arthroscopy of the Shoulder - MR Arthroscopy of the Shoulder - MR of the shoulder
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925366
|Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire|
|Paris, France, 75010|
|Principal Investigator:||Jean-Denis Laredo, Pr, PhD||Assistance Publique - Hôpitaux de Paris|