ShoulderCOIFFENCT00925366
Which is the Most Reliable Radiologic Examination for the Diagnosis of Rotator Cuff Tendon Tear?
A study testing Imaging Procedure in people with Shoulder and Rotator Cuff Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder, Rotator Cuff Disease
- What is being tested?
- Imaging Procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2003to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient whose age is > to 18 years
- Patient presenting a clinical suspicion of rotator cuff tear
- Obtaining the enlightened consent of the patient
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire
Paris, 75010
About this study
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.
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.
- Conditions
- Shoulder, Rotator Cuff Disease
- Being tested
- Imaging Procedure
- Keywords
- Shoulder, MRI, MR arthrography, CT arthrography, Rotator cuff tear, Arthroscopy
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging ProcedureOther
CT Arthroscopy of the Shoulder - MR Arthroscopy of the Shoulder - MR of the shoulder
| Study group | Role | What they receive |
|---|---|---|
| Shoulder rotator cuff tear | Other | Shoulder rotator cuff tear Receives: Other: Imaging Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startSep 2003
- Primary completionSep 2007
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShoulderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Denis Laredo, Pr, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925366
- Sponsor's protocol ID
- P020909
- Acronym
- COIFFE
- Status last verified
- Jun 2009
- First submitted
- 19 Jun 2009
- Last updated
- 29 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00925366
- Acronym / sponsor ID
- COIFFE / P020909
- Conditions
- Shoulder, Rotator Cuff Disease
- Keywords
- Shoulder, MRI, MR arthrography, CT arthrography, Rotator cuff tear, Arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder rotator cuff tear | Other | Other: Imaging ProcedureShoulder rotator cuff tear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient whose age is > to 18 years
- Patient presenting a clinical suspicion of rotator cuff tear
- Obtaining the enlightened consent of the patient
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging ProcedureCT Arthroscopy of the Shoulder - MR Arthroscopy of the Shoulder - MR of the shoulder | Other | Shoulder rotator cuff tear |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2009.
Related trials for Shoulder
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Active, not recruiting
At Home, Digital Rehabilitation for Patients After Reverse Total Shoulder Arthroplasty
Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Denis Laredo, Pr, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging Procedure in people with Shoulder and Rotator Cuff Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2009.