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

NCT00925366 | Completed

• 1 other identifier: P020909
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder; Rotator Cuff Disease

Keywords

Shoulder; MRI; MR arthrography; CT arthrography; Rotator cuff tear; Arthroscopy

Outcome Measures

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.

  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

  6 months

Study Arms (1)

Shoulder rotator cuff tear

OTHER

Shoulder rotator cuff tear

Other: Imaging Procedure

Interventions

Imaging Procedure OTHER

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

Shoulder rotator cuff tear

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient whose age is \> to 18 years
• Patient presenting a clinical suspicion of rotator cuff tear
• Obtaining the enlightened consent of the patient

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire

Paris, 75010, France

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Jean-Denis Laredo, Pr, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 19, 2009
• First Posted: June 22, 2009
• Study Start: September 1, 2003
• Primary Completion: September 1, 2007
• Study Completion: June 1, 2009
• Last Updated: July 29, 2009

Record last verified: 2009-06

Locations

FR (1)