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Distal Clavicle Resection With Rotator Cuff Repair

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ClinicalTrials.gov Identifier: NCT01040065
Recruitment Status : Unknown
Verified June 2011 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : December 25, 2009
Last Update Posted : June 29, 2011
Sponsor:
Information provided by:
Samsung Medical Center

Brief Summary:
The purpose of this study is to determine whether distal clavicle resection is effective treatments in patients with acromioclavicular joint pain accompanied by rotator cuff tear.

Condition or disease Intervention/treatment
Acromioclavicular Joint Arthritis Procedure: distal clavicle resection

Detailed Description:
Today, acromioclavicular joint syndrome is itself rarely a cause for hospital visit, and the need for its treatment is even rarer. In comparison, patients who suffer rotator cuff tear accompanied by shoulder impingement syndrome often complain of acromioclavicular joint pain. However, often patients who complain of severe pain have no positive findings on X-ray or MRI, or any sign of impingement. On the other hand, there are patients with positive findings on X-ray or MRI who have only little pain. Even a patient who in the out-patient-department complained of acromioclavicular joint pain on pressure may feel pain on pressure in the physical exam performed for rotator cuff tear surgery. The opposite is very frequent as well, so it is often different depending on the time and the performer. In the literature, there are some authors who maintain that a distal clavicular resection must be done when surgery is used to treat the impingement syndrome, while on the other hand, there are those who endorse only complaining (an operation to trim the distal clavicle and the protruding part of adjust the plane acromion in order to level their plane), and also those who propose an all or none approach to either perform a distal clavicular resection or not at all. Thus, there are varying opinions depending on the authors; moreover, these are all observational studies, and none report on the rotator cuff tear injury. The authors of this study hypothesize and will prove that since the osteoarthritic change and pain of the acromioclavicular joint is secondary to impingement syndrome, distal clavicular resection on rotator cuff repair surgery will have no long term effect.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Distal Clavicle Resection of Symptomatic Acromioclavicular Joint Arthritis Combined With Rotator Cuff Tear. Prospective Randomized Trial
Study Start Date : June 2008
Actual Primary Completion Date : February 2010
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: distal clavicle resection
    Presence of tenderness at 2 years after surgery
    Other Name: mumford procedure


Primary Outcome Measures :
  1. the presence of acromioclavicular joint tenderness [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. American Shoulder and Elbow Surgeons score [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
medium sized rotator cuff tears
Criteria

Inclusion Criteria:

  • rotator-cuff tear requiring repair
  • acromioclavicular joint tenderness more than moderate(Pain Visual Analogue Scale 4-7)
  • acromioclavicular arthritis(Petersson Grade II-III)

Exclusion Criteria:

  • Arthritic changes of glenohumeral joint
  • Combined infection
  • Mini-open, open procedures
  • Complete subscapularis tear
  • Incomplete repair
  • Neurologic abnormality including axillary nerve
  • Adhesive capsulitis
  • Prior surgery, trauma, or infection on shoulder girdle
  • SLAP lesion or biceps tendon lesion without rotator-cuff tear or impingement syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040065


Contacts
Contact: Jae Chul Yoo, MD 821099333501 shoulderyoo@gmail.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Jae chul Yoo, MD    821099333501    shoulderyoo@gmail.com   
Principal Investigator: Jae Chul Yoo, MD         
Principal Investigator: Kyoung Hwan Koh, MD         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Jae Chul Yoo, MD Samsung Medical Center