Which is the Most Reliable Radiologic Examination for the Diagnosis of Rotator Cuff Tendon Tear? (COIFFE)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00925366
First received: June 19, 2009
Last updated: July 28, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention
Shoulder
Rotator Cuff Disease
Other: Imaging Procedure

Study Type: Interventional
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.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: September 2003
Study Completion Date: June 2009
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00925366

Locations
France
Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Denis Laredo, Pr, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Myriem CARRIER, Department of Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00925366     History of Changes
Other Study ID Numbers: P020909
Study First Received: June 19, 2009
Last Updated: July 28, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Shoulder
MRI
MR arthrography
CT arthrography
Rotator cuff tear
Arthroscopy

ClinicalTrials.gov processed this record on August 28, 2014