Trial record 3 of 7 for:    Open Studies | "Acromioclavicular Joint"

Distal Clavicle Resection With Rotator Cuff Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01040065
First received: December 23, 2009
Last updated: June 28, 2011
Last verified: June 2011
  Purpose

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 Intervention
Acromioclavicular Joint Arthritis
Procedure: distal clavicle resection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • the presence of acromioclavicular joint tenderness [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • American Shoulder and Elbow Surgeons score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2008
Estimated Study Completion Date: March 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: distal clavicle resection
    Presence of tenderness at 2 years after surgery
    Other Name: mumford procedure
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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Jae Chul Yoo, MD, Samsung Medical center
ClinicalTrials.gov Identifier: NCT01040065     History of Changes
Other Study ID Numbers: 2008-08-002
Study First Received: December 23, 2009
Last Updated: June 28, 2011
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Samsung Medical Center:
Acromioclavicular joint arthritis
distal clavicle resection
Mumford procedure

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 24, 2014