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- Klinische proef NCT00925366
Which is the Most Reliable Radiologic Examination for the Diagnosis of Rotator Cuff Tendon Tear? (COIFFE)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Paris, Frankrijk, 75010
- Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patient whose age is > to 18 years
- Patient presenting a clinical suspicion of rotator cuff tear
- Obtaining the enlightened consent of the patient
Exclusion Criteria:
- Patient having refused to sign his consent
- Patient whose age is < to 18 years.
- Patient with capsulitis
- Patient presenting history of allergy.
- Patient presenting an anticoagulant or salicylated treatment which can not be interrupted.
- Pregnant woman.
- Patient with a contra-indication to MRI.
- Patient with a psychiatric pathology preventing a clinical evaluation.
- Patient with contra-indication (cutaneous or different) to the intra-articular injection.
- Patient with a history of non degenerative pathology in the same shoulder (inflammatory disease, serious infection, tumor…) or with past intervention on the same shoulder.
- Surgery contra-indication (cardiac failure, respiratory…)
- Patient without health coverage.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: Shoulder rotator cuff tear
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CT Arthroscopy of the Shoulder - MR Arthroscopy of the Shoulder - MR of the shoulder
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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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.
Tijdsspanne: 6 months
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6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To improve our knowledge of the radiological aspect of degenerative lesions of rotator cuff tendon thanks to clinical, radiological and surgical confrontations
Tijdsspanne: 6 months
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6 months
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Jean-Denis Laredo, Pr, PhD, Assistance Publique - Hôpitaux de Paris
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- P020909
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Klinische onderzoeken op Schouder
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Issa, Abdulhamid Sayed, M.D.VoltooidSchouder Impingement Syndroom | Rotator cuff tendinopathie | Adhesieve capsulitis en het Frozen Shoulder SyndroomSyrische Arabische Republiek