CClinicalTrials.gg
CompletedNCT00925366COIFFEUpdated Jul 29, 2009

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

An interventional study of Imaging Procedure in Shoulder and Rotator Cuff Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-07-29.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Shoulder
  • Rotator Cuff Disease

Keywords

  • Shoulder
  • MRI
  • MR arthrography
  • CT arthrography
  • Rotator cuff tear
  • Arthroscopy
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,504 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Other
    Shoulder rotator cuff tear

    Shoulder rotator cuff tear

    Other: Imaging Procedure

Interventions

  • OtherImaging Procedure

    CT Arthroscopy of the Shoulder - MR Arthroscopy of the Shoulder - MR of the shoulder

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire
    Paris, 75010, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00925366
Lead sponsor
Assistance Publique - Hôpitaux de Paris
First posted
Jun 22, 2009
Start date
Sep 2003
Primary completion
Sep 2007
Completion
Jun 2009
Last update
Jul 29, 2009

Study contacts

Jean-Denis Laredo, Pr, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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